March 10, 2025 • 52 mins
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The latest in our series of Business of Biotech podcasts recorded in-person at JPM in San Francisco features an inspiring conversation with Affinia Therapeutics CEO Rick Modi. Modi shares on how his upbringing in Kenya shaped his adversity-embracing worldview, and how that worldview contributes to his biotech leadership. We cover his transition from pharmaceutical work in Iowa to a career in biotech, the gene therapy advances Affinia is building on, the company's investment approach, its upcoming clinical trials, and much more.
The 2025 BoB@JPM series is supported by Alston & Bird, whose national health care and life sciences practice has more than 100 attorneys actively involved and integrated across the full spectrum of legal disciplines including regulatory, compliance, public policy, transactional, corporate governance, securities, FDA, biotechnology, intellectual property, government investigations, and litigation practice areas. Learn more at www.alston.com.
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Matt Pillar (00:04):
I'm Matt Pillar.
This is the Business of BiotechJPMorgan 2025 edition, and I'm
here with a man who knowsadversity and challenge quite
well Rick Modi.
Born in Kenya, 17 years inKenya.
Then he decided to come to theUnited States of America.
This is a story we're going tohear very shortly His decision
(00:25):
to come to the US and earn hisdegree in pharmacy and then
launch a career in life sciences, leading up to his leadership
now at Affinia Therapeutics,where he serves as CEO at
(00:45):
Affinia Therapeutics, where heserves as CEO, so we're going to
get right into that story.
We're here, by the way, we'rehere at the offices of Alston
and Bird, in partnership withAlston and Bird, and I'm very
thankful to Alston and Bird, avery reputable law firm in the
biotech space.
If you have any needs for legaladvice in biotech, alston and
Byrd is the place to be, socheck them out.
Rick Modi (01:07):
But yeah, we're here and I want to start right there.
Matt Pillar (01:09):
I want to hear the story about what led up to your
decision to come to the US andearn a pharmacy degree in Iowa.
Rick Modi (01:22):
Sure Matt.
So first thank you for havingme on here as a guest.
Very humbled to be here.
Pleasure to meet you.
The story is very, veryinteresting.
So I was born in Kenya.
When people meet me, by the way, say you don't look Kenya.
Matt Pillar (01:35):
What is?
Rick Modi (01:36):
your heritage.
I'm Asian Indian by heritage.
Kenya is a British colony.
In those days there were a lotof Indians that they brought to
Kenya to do work and they stayedover and started shops and
families and kids like me at thetime.
So I spent 17 years in KenyaAmazing journey living in a
third world country.
People talk about survival ofthe fittest.
Physically, this is survival ofthe fittest because you end up
(01:59):
getting malaria and you surviveit.
It's survival of the fittestbecause there's not enough room
in the next classroom and if youare not, you know working hard
enough you get cut out prettyquickly.
But yeah, I always wanted toget into the medical field.
I mean it was pharmacy,physician, those types of
careers.
And I looked up again.
Many people in these thirdworld countries look up to the
(02:19):
US and say wow, great education,land of opportunity.
So I always had this vision andwant and desire to be in the US
.
The pharmacy school in.
Iowa was one of the top five, sothat's how I ended up choosing.
Matt Pillar (02:31):
Iowa.
Rick Modi (02:32):
It was also one of the cheaper cost of living and
for somebody coming from a thirdworld country to a very
well-developed first worldcountry, cost of living is a
major factor.
Matt Pillar (02:41):
Yeah.
Rick Modi (02:42):
So I got admitted in January in Iowa.
So Kenya is on the equator,beautiful weather, and they use
centigrade, not parametrized.
But we'll come back to that atsome other point Going from
beautiful tropical weather to inthe dead of winter.
Iowa was one story, but I alsogrew up vegetarian and I only
(03:06):
had two food choices in Kenya itwas either corn or beef.
You can imagine how long, muchlonger, I was vegetarian after
moving to Kenya actually.
Matt Pillar (03:14):
Yeah, that's wild.
So you talk about growing up ina third world country and then
making that transition.
Aside from the climate and yourculinary options?
Were you prepared, coming outof an education in Kenya, to
come over here and I mean, wereyou educationally equipped to?
I mean, obviously you got in,but I'm just curious about that.
Rick Modi (03:37):
Sure.
So the education in third worldcountries is actually very
buttoned up in the case of Kenyabecause it was a British colony
way back when they followed theBritish system.
So the British system hasordinary levels, advanced levels
.
They follow the generalcertificate of education, which
many people in the US would notknow what it is, but they are
essentially examinations thatplace people.
Matt Pillar (03:59):
And to give you an idea.
Rick Modi (04:02):
My high school education in Kenya gave me 32
credit units for the universitylevel in the US, so I got a head
start on that and also givesyou an idea of what the standard
of education in Kenya was.
You have to watch your tail off, to be honest, in a third world
country, and the standards arereally, really good.
I was fortunate enough to alsogo into an English speaking
(04:24):
school, which also helped me getpast TOEFL and all these other
tests that you have to gothrough to come to the US.
Matt Pillar (04:32):
Yeah, what did your parents do in Kenya?
Rick Modi (04:34):
No, I was a stay-at-home parent.
My dad was in the bankingsector and when I tell people in
the US who was in the bankingsector, they think oh, it must
not be banking.
No, he was a banking teller anda cashier initially and then
worked his way up into the loandepartment and such, but they
were hardworking people madeends meet, just like hardworking
(04:55):
people do Instilled in me workethics, integrity all the values
that even to this day I lookback and I'm so thankful to my
parents for imparting on me.
They did fund part of myeducation but the rest was
classically.
you know people that come to theUS.
They get a job in a lab workingin the pharmacy school, which
is what I did.
(05:16):
And then also, you know, inaddition to doing the pretty
deep and extensive curriculumthat pharmacy actually requires
as well, it was a hard work, itwas fun Many people, by the way,
that come from other countriestoo.
One of the great things aboutAmerica is also it's a fun,
loving place as well.
So, like every other collegekid, I also had my part of fun.
(05:36):
You know going out to SouthPatrick for like spring break
and you know doing all thethings that college kids do and
are probably not supposed to bedoing.
Matt Pillar (05:42):
But that was part of the experience.
Yeah, where did the interest inlife sciences come from?
I mean, your mom's astay-at-home mom.
Your dad was a bank teller inKenya.
You know, was it yourexperiences in Kenya, with some
of the health problems overthere and diseases that Kenyans
face, what was sort of thenucleus of your desire to put
(06:05):
the work in to become apharmacist?
Rick Modi (06:07):
Yeah, that's a good question.
In some countries, such asKenya, for example, there are
some fields that are looked uponwith very deep respect.
The health sciences is certainlyone of them.
So my initial career choice wasactually becoming a physician.
Yeah, Help patients do right bysociety, all those things.
Pharmacy was my stepping stoneto become a physician and just
(06:30):
to be very good in pharmacy andended up having a career in
pharmacy.
I decided to stay put in thatand I'm very happy that I did.
Eventually went back tobusiness school actually for my
graduate studies, but plan A wasbecoming a doctor, to be honest
, and it was looked in with highregard.
Um, my kids, by the way, are intheir 20s right now.
I have twins, twin boys, andthey, like many kids on that age
(06:53):
, they're, they're working rightnow.
But also wondering is thistheir end stage career?
Will they switch careers?
And I tell them, go and havelike, do things that you enjoy
doing and and it will take careof itself.
It's easier said than done,right, it's easier at this point
to look back and say, yeah, Ishould just follow my heart and
do the things that I enjoy doing.
Of course, in the moment whenyou're debating debating between
(07:15):
a first career or a pharmacistor a physician, or going back to
grad school for business uh, inthe moment those are really
difficult decisions.
But I look back and I say, ifyou work hard and go with the
things that your naturalstrengths are, you should be
okay.
Matt Pillar (07:31):
Yeah, yeah.
No, I can appreciate that.
I have a 20-year-old and an18-year-old, you know, and the
pressures that they receive fromevery influence beyond their
family, you know, to makechoices and choose tracks.
It can be overwhelming forthose kids sometimes and you
know, as dads we sort of have togive them that safe space to
say, look, you know, we've beenaround and it's not all riding
(07:53):
on the decision you make today.
Right yeah, so yeah, gettingback to your career trajectory
the pharmacy to pharmatransition the, the pharmacy to
pharma transition.
Rick Modi (08:09):
Tell me, tell me how that came to, came to pass.
Yeah, so after graduating fromiowa, I, I went to, I came to
california.
We're in california right now.
So I came to california and did10 years in a hospital pharmacy
.
Uh line of work um, it wasgreat because it anchored me.
Uh, these were patients in the,the ICU, where pharmacists are
called upon to dose antibiotics.
These were babies bornprematurely.
The pharmacists were called into start IV nutrition.
(08:30):
As an example, you were on thefloor side by side with
physicians and nurses andsometimes patients and parents
to lend your expertise as ahospital pharmacist.
It was great up to a certainpoint I started getting into
administration within thathealthcare system and then I
began liking the business aspectof things as well, the
administrative part and some ofthe entrepreneurial things that
(08:53):
also come from becoming apharmacist as well.
Matt Pillar (08:56):
Was that part of your pharmacy training, Like
when you were in pharmacy school?
Is there a fair degree of like?
You know, we're going to equipDr Modi to become potentially an
independent pharmacist, orwe're going to equip Dr Modi to
become potentially anindependent pharmacist we're
going to teach some business.
Rick Modi (09:08):
A little bit, I would say, but not that much.
Most of the curriculum isgeared towards science.
Yeah, I'll say the thing that Ilearned the most, both from
pharmacy school as well as thedecade as a working hospital
pharmacist.
They call it SOAP, S-O-A-P.
It's an acronym that physiciansuse quite a bit when they
(09:30):
evaluate patients.
So the S is for subjectiveassessment, the O is for
objective assessment, the A isfor assessment itself, and then
you apply them.
Many people in the businessworld sometimes draw an analogy
between the business situationand a patient.
The treatment is worse as anexample right, it's a benefit.
(09:51):
Risk is an example for adecision you're making.
Those are the skills that Iwould say that I learned a lot
more, that were more applicableto the business world.
But it was very similar in thatsense, you take metrics that are
non very subjective, you addmetrics that are very objective,
quantitative, and then you makean assessment and then find
(10:12):
it's a very analytical field,the pharmacy field, and those
are the skills that helped me,but more than anything I would
say was more transitioning frommany people with a technical
expertise start growing up inthe ranks and then end up being
in a business type of a role.
I began a second love in thesecond part of the business
(10:32):
world Right, and that's where Icompelled.
I got compelled enough to say,well, wouldn't it be great to go
back to business school and geta graduate degree and do all
these things that I'm seeingwith new drugs in the hospital,
on the investigational ReviewBoard, on the Pharmacy and
Therapeutics Committee?
Wouldn't be good to apply whatI'm learning here into bringing
these medicines from the otherside right?
Matt Pillar (10:54):
Yeah.
So what did that movement tell?
You went back to businessschool, right?
Did you get your MBA?
Is that what you did?
Rick Modi (11:00):
I did.
I went to Penn with two little,the twins that I referred to.
Until at the time, they werebarely not even two years old.
Matt Pillar (11:08):
So Iowa to California, to Philly, to Philly
yeah.
Rick Modi (11:12):
And we, literally we, sold everything.
The wife was, of course, youknow not, not excited about it
but came along for the ride as Iwould say yeah, and.
And we put the strollers on thetop of the van and moved cross
country and the next two-ishyears year and a half two years
everything was at risk.
(11:33):
To be honest, full-time,student, full-time yeah, I did
it the hard way, it's probably arecurring thing in my life,
whether it was planned or not.
We can do it at some point, butI did it the hard way.
I quit the job.
My wife quit the job.
She was a working nurse as well, and we were both essentially
just living on loans and goingfull time.
(11:53):
I was going to full time andshe was taking care of the kids
initially.
Matt Pillar (11:57):
Yeah, wow, you have a great wife.
I would agree.
Rick Modi (12:01):
We're coming up on 30 years now.
Congratulations.
Matt Pillar (12:04):
Yeah.
Rick Modi (12:10):
So you stick it out full-time at Penn, get your MBA
and then what?
Another interesting story andit always goes back to it's
never planned, at least for me.
I looked at banking coming outof business school.
Really it seemed like bankingwould be a good career.
Everybody was talking aboutbanking as a place to be.
I looked at consulting because,again, people with MBAs look at
consulting as well.
Interestingly, theopportunities that came to me
(12:33):
were banking and consulting.
Actually, in some cases theywanted to interview me.
The ones that came to me werebiotech and pharma.
Yeah, and I ended up in a verysmall company called Centimore.
This was still in Philadelphia.
This was still in Philadelphia.
This was still in thePhiladelphia area, exactly yeah.
So, thankfully we didn't have tomove again my wife was happy
with that part and Centmor hadjust been acquired by Johnson
(12:56):
Johnson and they were launchinga drug, a biologic that is quite
well known now, of course,called Remicaine, but at the
time it wasn't that well knownand it was their first
indication at the time ofCrohn's and rheumatoid arthritis
.
And of course I had done mydiligence in looking at the
science.
But my first week was theeye-opener for me, that sealed
the deal and that I had made theright choice.
Matt Pillar (13:17):
Actually, and what happened in that first week.
Rick Modi (13:20):
So as happens in, many of these companies, when a
drug is approved, it's a bigcelebration.
Typically in biotech and pharma, the odds are against drugs
getting approved.
The science in the end are somany times it's just a very,
very tough and challengingpublic science and business.
Right With the approval ofRemicade, they got the company
together and did a companymeeting and as part of that
(13:42):
company meeting celebrationwhich is my first week, by the
way, so I'm climbing joiningthat company was just impeccable
.
Very fortunate, there was awoman on stage in her 50s and
she was a mom with two kids andthey wheeled her onto the stage,
but she got out of thewheelchair and her message to
(14:03):
the company was I was in yourclinical trial as a patient who
was involved.
I've been taking Remicade, thisinfused biologic that you all
have developed, and I can nowget up and my walking ability is
improving and I can now hold mykids.
And our message to us was thankyou.
And as I was sitting on thestage, I had no part of this.
(14:26):
I didn't develop the drug.
This is my first week, but tobe a part of that industry, a
part of that company, a part ofthat journey and being able to
say wow, I couldn't be a part ofmaking such a big difference.
That's what sealed the deal forme to say wow, if these
medicines work, the effect sizeof somebody not being able to
(14:47):
walk and then being able to getup and hug their children that's
a private moment.
So that was really like a baby,just to be already open.
Matt Pillar (14:53):
Yeah, for sure.
So how long did you stay withSenecor?
I was at Senecor for sevenyears.
Rick Modi (15:00):
What was your role there?
I was on the marketing,commercial side.
It was great because I couldtake everything I learned when I
was in the hospital all thepharmacy science that I learned,
all the conversations withphysicians, with patients, and
then the application of thebusiness aspect of things and
then be able to educate folksand be able to also place a
(15:20):
therapy like Remicade in theproper place, like in the
treatment paradigm.
That's what I believe biotechand also commercialization is
about the right patient choice,the right positioning and, for
that matter, also the righteducation on the benefits and
the risk of these products.
In those seven years welaunched Remicade in five
different indications.
It might have been sixRheumatoid arthritis is one.
(15:43):
Crohn's disease, ulcerativecolitis, psoriasis.
Psoriatic arthritis it wasdrinking out of a virus.
Literally.
It was amazing learning.
We made a huge difference andwe continued doing lifecycle
management obviously kind of gotup as well.
Matt Pillar (15:57):
Yeah.
So at what point did you startto get the entrepreneurial itch,
like you're?
You know Senecor, johnsonJohnson.
You're in a pretty establishedrole as an established company
doing commercial work for anestablished product.
You know where does this desireto move?
Rick Modi (16:17):
way back to the other side of that continuum in
biotech come from.
Yes, sometimes I believe it'sjust a natural journey For me.
Centercore led to MediMune,another biologics company.
Matt Pillar (16:31):
Again, MediMune was already part of AstroSumicat.
Rick Modi (16:33):
So we were a subsidiary in launching,
building up the pipeline andlaunching additional drugs.
But in MediMune I started doingmore corporate strategic type
of initiatives, including one onbehalf of us or something like
that as well.
So that's where what I wouldsay good judgment skills became
important, and more at thehigher level.
These are decisions aboutfranchises, about size, about
(16:55):
indication selection, but it wasstill working through
governance.
It takes a long time to gothrough in big companies,
various governance meetings.
It takes a long time to gothrough, in big companies,
various governance meetings and,as I developed, these skills
(17:17):
more the ability and the courageto say I can do this in a
smaller setting, became moregermane and more attractive.
So, guess what?
I moved back to California fora smaller company called
Intermune All the way back, yes,In the Bay Area and this was a
company that was developing atherapy a small molecule this
time called Aspirin in a diseasecalled idiopathic pulmonary
fibrosis, and we brought that toapproval and launched that drug
(17:40):
.
And then eventually Rocheacquired the company.
But that company had beenworking on Esprit in the past.
One phase three trial had beenpositive, another one had been
negative and when I joined theywere doing the third trial to
prove or disprove whether thedrug would really work in this
population.
So I was taking significantrisk.
(18:00):
Again I look back and I say,wow, isn't it great that we
brought another therapy topatients and you know, ones that
are in need with idiopathicpulmonary fibrosis.
After that I haven't lookedback at no big company since
then.
It's been all entrepreneurial,all small companies, including,
obviously, you know since thenAvaxis and then now Athenia.
Matt Pillar (18:19):
Yeah, yeah.
So tell me about that story.
How did your, what was yourexposure to it?
Finneas that led you to CEOchair there?
Rick Modi (18:28):
Yeah.
So I think in some cases myjourney is quite typical.
In other cases it's atypical.
What I mean by that is theproving grounds in big companies
, where skill acquisitionhappens, is quite typical.
And then the graduation fromthere might not seem like
graduation at the time and thenthe graduation from there it
does seem like graduation at thetime.
But the graduation from thereto smaller companies, where then
(18:50):
you start expanding your wingsand get into higher roles and
more, bigger responsibilities,is pretty typical and one that I
have enjoyed because when I'vegone into the smaller companies
I now believe I'm anchoredenough and I am courageous
enough to make these decisionsright.
So when I was at Avexis webrought another gene therapy to
patients called Sotresa.
(19:11):
These are kids with spinalmuscular atrophy.
We give them this one-timetherapy.
It's infused as an IV infusion,we give it to them shortly
after birth and the disease iscalled floppy baby syndrome.
It's hard-running enough wheremany of these babies cannot
really function.
They never get the ability tostart walking and such, and in
(19:34):
many cases they can actuallypass away before the age of two.
So it's one protein that'smissing, the SMN protein.
So with the gene therapy wedeliver, using a capsid, this
missing gene and the gene goesto work and these babies are
safe.
So being a part of that teamwhere we brought that therapy to
(19:55):
that patient community andbeing able to help those parents
and those kids they have theirown careers now it was
life-saving for them andlife-changing just to be a part
of that team.
But that's also where I realizedthis particular technology can
be useful in so many otherdiseases.
The problem, however, is youcannot get all the different
(20:18):
types of genes to make thesetypes of curative benefits with
the conventional capsules thatare available out there.
So when I left Avexis, thatcompany was bought up by
Novartis.
After we got the approval, avery good colleague of mine, ed
Mothers, who's a very well knowninvestor with new enterprise
associates, nea that I'd beenworking with at MetaMune
(20:41):
actually way back when, hadapproached me to see what I was
doing and I had consideredmultiple different CEO roles.
But he said hey, I know ascientific leader who is in the
gene therapy space and is tryingto start a company.
That gentleman's name is LukeVandenberg and quite well known.
He co-invented one of theinitial capsules, c89.
So he introduced the two of us.
(21:03):
It was a phone call in a lateevening.
It was supposed to be 30 minutesand we just spent talking into
the evening.
We met in person later thatweek and he told me what he was
trying to do and I had neverstarted a small company before,
forget like a startup.
But I loved what he was tryingto do.
It was gene therapy coming off.
(21:24):
Just seeing what gene therapycould do with the kids in spinal
muscular atrophy, I was hookedand he was doing exactly what we
believed, what I believed thelimitations of interventional
capsules were.
So I took the risk and I saidI'll partner with you.
I haven't done a startup before, ever.
There's no money around thetable right now.
I understand the science enoughto realize.
(21:45):
Of course it's going to be aslog, as I will call it, just
like everything else in science,but sure, we we connected and
we're now five years in.
Matt Pillar (21:54):
Yeah, all right.
Well, there's a lot of severaldirections we can take, all
right.
So you're sitting around thetable and you decide that you're
going to get in on thisopportunity, this project, if
you will.
Right, what did you?
You'd never done a startupbefore.
So what was like?
What was job number one for youpersonally to say, okay, like
(22:15):
we're going to make a companyout of this, I need to.
X.
Rick Modi (22:19):
Yeah, it's a good question.
With any startup, the firstthing is do you have the money?
Can you get the money?
So I to just do the initialwork was six months of work just
figuring out the strategy,figuring out the science,
putting the pitches together.
There's no pay in that.
Matt Pillar (22:37):
You're on your own, yeah, but you and your wife
have been there before.
Was she as receptive to it thistime around?
Rick Modi (22:47):
By the way, I love my wife.
She still works as a nurse,which she is receptive to at
this time around.
By the way, I love my wife.
Matt Pillar (22:50):
She still works as a nurse.
Rick Modi (22:52):
So she enjoys the same things that drove me all my
life the patient interactions,knowing that we could be a part
of this community, knowing thatwe could leave a legacy if it
does work out right.
So that was the again I'll say,the anchoring.
That's the mission, that's themotivation, right?
So, yes, there's no pay for afew months, but there's the hope
(23:14):
, the conviction and the courageto say, well, we could do
something here.
So in those six months, you'rewriting personal checks to say I
need a few more people to getsome work done.
I need a facility which youstart with a shared space
initially, but then you alsoneed labs to start.
So all that was initially apersonal check, while we were
(23:36):
trying to travel funding forwhat is called a seed financing,
right, yeah, so we startedcalling on investors.
I'm again very, I'll say,fortunate, lucky, blessed, but
some is just being there at theright time at the right place
sometimes, where the priorcompanies and the successes that
we had in bringing therapiststo patients also rewarded
(23:58):
shareholders and investors.
Right, so I had now afollowership that I could call
on and say look, this is whatwe're trying to do.
Would you take the meeting?
Let me walk you through whythis particular company could be
a good fit for you.
Right?
So we did that and did the seedfinancing initially, and then
the series A, but those were ourdays.
Sure, you said this was fiveyears ago.
(24:23):
This was 2019.
And of course, you and I knowalso what happened in 2020, this
was 2019.
And of course you and I knowalso what happened in 2020, you
know, called the pandemic,unfortunately, Our friends at
Alston and Byrd set us up withsome amazing space to record
during JPM week.
Matt Pillar (24:42):
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(25:25):
commercial launch.
Learn more at alstoncom andtell them you learned about them
on the Business of Biotech,yeah.
I mean pandemic aside, I wasgonna ask your perspective on
where we were on this sort ofdelivery vehicle fervor in 2019.
(25:47):
Like there's a lot of attentionbeing paid to delivery
mechanisms for gene therapiesand you know how we're
navigating them to the righttissues In 2019, what was it
sort of you know early days forthat, for exploration of that,
or was it in full swing?
Rick Modi (26:05):
It was a bit of both in the following ways in full
swing it was a bit of both inthe following ways.
Conventional gene therapy wasan uptick, so Avexodus was
acquired by a big company.
There were a few other dentistswas acquired by a big company,
right.
So there was a belief thatconventional capsules would be
good enough and it would be copyand paste very, very easy Again
.
Biotech is never easy and pastevery, very easy.
(26:25):
Again, biotech is never easy.
So there did be at the point itwas good but it didn't last
long where people realizedconventional capsids will not
cut it and that developing newcapsids would be the solution to
that.
Again, as often happensincluding me I thought
developing new capsids would beeasy.
It was a journey, so again ittakes.
(26:48):
You think it's going to be donein months.
Sometimes it takes years.
You think the first indicationyou select will be S-lambda.
Sometimes it's not the firstindication, it's the second or
the third choice, right so to beable to persevere during the
time.
It happens in every biotechcompany, maybe not the first
time, but maybe the third or thefourth time.
But this is biotech.
The odds, unfortunately, areagainst drugs getting developed
(27:10):
and getting eventually toapproval.
So those early days was veryinteresting with the investor
dialogues, because with somefunds the time horizon just
doesn't match with what thecompany is trying to do and how
long the science is going totake to mature, especially when
you're in licensing somethingfrom academia into industry.
Matt Pillar (27:31):
You need to redo the experiments, you need to
find the right indication andpatient community to serve, and
the translational aspect is verydifferent than the research
aspect of things yeah, so tellme a little bit about your, your
approach to that, like whatwhat's your um, what what's your
risk aversion sort of strategywhen you know you don't
(27:52):
necessarily know what the marketis going to, especially in the
you know you mentioned thepandemic.
I mean you know, pandemic yearswere financially pretty good, at
least early right, and theneverything goes crazy.
So what sort of managementapproach to that risk has
allowed you to persevere to yourpoint?
Rick Modi (28:14):
Yeah, so I call it accumulation of experiences.
As one goes through a career,or maybe life in general as well
, one learns a few things aboutgood judgment.
I believe for a leader, and aleadership team in particular,
that's one of the best skillsets to have.
How do you render good judgmentwhen data can be conflicting
(28:37):
even with each other?
Right, it can be scientificdata, it can be business data,
it can be market, economic, itcan be the fundraising
environment.
So triangulating that backagain to when I was in the
hospital and using the SOAP theSubjective Objective Assessment
Plan is what drives theperseverance and the good data.
(28:58):
In biotech it's easier than, inmy opinion at least, than in big
pharma, where again, thegovernance bodies can be just
more off our track.
So we were able to make thesecalls as we recruited a great
team of experts, coming inpeople from different companies.
I could have brought again thesame people that I'd worked with
before, but I chose not to, andbringing that diversity in
(29:19):
thinking and across functionsallowed us to take in stride
whatever circumstances that werethere, and that included the
pandemic.
So, yes, from a financingperspective, there was more
money flowing in the era, butfrom an operational perspective.
That was really, reallychallenging for the people that
were affected and also for theleadership that still had to
deliver during that time.
(29:39):
So those things just came withall the prior circumstances that
we have been through, that Iwas wasn't through.
You can then see patternrecognition.
I've seen a movie like thisbefore.
Let me make some judgment callstoday.
Let's see how it unfolds andthen let's course correct if we
need to, like those were whatsaved the day many, many times
(29:59):
over.
Sometimes it was my experience,sometimes it was, you know, my
colleagues experienced the chiefscientific officer or the chief
development officer, the chiefbusiness officer, the chief
medical officer and the board.
It was the collective that Ialways the chief development
officer, the chief businessofficer, the chief medical
officer and the board.
It was the collective that Ialways say is always better than
the individual.
Matt Pillar (30:13):
Yeah, that's interesting.
Have you always been reallygood at maintaining emotional
control in the face of challengeand adversity In the older days
.
Yes, Less so in the youngerdays.
Rick Modi (30:26):
Not to make it about demographic, but I think
anchoring can come with just andsteadiness is the other word I
would use in what you'redescribing can just come from
again when you've seen moremovies, right type of thing, so
you can take more things instride.
Sometimes it's not justprofessional experience, it can
just be you had a child orsomebody in your immediate
(30:48):
family or passed away.
These things also just putthings into context and
experiment that went bad orsomebody left the company.
You're just able to put thingsmuch more in context and say
wait a minute, this is what Ican control, this is what I can
control and honestly, gettingemotionally distraught about it
is not even a consideration,right, but I wouldn't say in my
(31:10):
younger days I was like that,Like with everybody, we do take
things to heart.
We are an organization, by theway, that is very open to
feedback.
That does take time to develop,meaning we give each other
feedback.
Nobody takes it personally, butI believe that actually is
really important for developingan organization that
continuously learns and thefeedback also provides mutual
(31:33):
steadiness too.
So if I am facing a circumstancewhere perhaps I'm having more
difficulty to take it in stride,I have a colleague next to me
who knows how I react to thatsame circumstance and is going
to help me have more of a steadyhand in that situation.
Right yeah, that samecircumstance and is going to
help me have more of a steadyhand in that situation.
We look after each other and, atthe end of it all, I do believe
people will remember thosememories how we went through
(31:55):
crisis and celebrations togetherand how we reacted in the
moment.
So I do believe that's superimportant.
Matt Pillar (32:01):
Give me a sense of who the we is at this point.
For Afinia, what does thecompany look like?
Yeah, it's amazing.
Rick Modi (32:06):
We're about 60 people overall 60 people.
Each one is handpicked withjust the skill set that they
bring, the achievements thatthey've brought in the past, and
then the cultural aspects ofthings as well.
In the leadership team we haveCharlie Albright as our chief
scientific officer, veryaccomplished individual from BMS
, editas, et cetera.
Laura Richmond, our chiefdevelopment officer she was at
(32:28):
the University of Penn at thegene therapy program, the
executive director there with me, and Manny Mew, our select in
the middle there.
Rami Daud, who, coincidentally,I went to school with at Morton
and then we reunited afterabout 25 years, again very
accomplished.
Lilly, human Genome Sciences,auxilium, etc as well.
And then, most recently I willnot be able to disclose the name
(32:50):
, but we have just hired a chiefmedical officer who will be
joining in just about a coupleof weeks actually from now.
And then Rob May is the lastperson who gets over
manufacturing with theIntervaxxers as well.
Matt Pillar (33:02):
By the time this episode drops that chief medical
officer will likely be known.
Yeah, yeah, congratulations.
Yeah, I mean you.
You highlight theaccomplishments of these folks
that you put together on theteam.
What, what was the you know?
Tell us about the challenge ofputting together, scaling up
that leadership team, you know,to align expertise with the
(33:28):
mission of Affinia.
Was it tough?
Rick Modi (33:32):
It's always tough assembling the right team.
I would say recruiting was good.
I wouldn't call it tough, butperhaps because of the various
companies that I've been at,it's the same diversity in
companies that I was at thatexpanded my network.
That also allowed me toapproach investors but also
(33:55):
build out the board as well.
So between the leadership teamand the board we've had exposure
to I don't know what it is 20or 30 companies.
So you amplify that with theentire network of 20 or 30
companies, or 30 companies, soyou amplify that with the entire
network of 20 or 30 companiesYou're just able to speak with
people, make a phone call andthen get a really good, diverse
(34:15):
set of individuals coming intothe company, both at the board,
the individual at the leadershipand also the part of their
organization as well.
The track record, I would say,helps significantly.
So when I can go in front offolks and say I've been at
CenterCorp, metaimmune,interimmune, amexis, I'm
starting to thin out.
They know these companies arefairytale companies in biotech.
(34:36):
And the number of medicationsand patient communities that got
approved with these drugs is,again, I will just say, uncanny.
You have that many.
And it's the same thing for theother people that have the
pleasure and the privilege ofworking with side-by-side in the
management team.
So it's been good to be able torecruit people from that
perspective.
But assembling the team stillrequires careful thought.
(35:00):
And then the other thing that Iwould also say after you
assemble, getting the rightdynamic is also really, really
important, Because the entire60-ish people that are in the
company are relying on theleadership team for making
co-check decisions, beingaligned, and we debate things
really well, very candiddialogues, but when we have made
(35:21):
the decision that we wantflawless execution right.
So putting a culture togetherthat allows the candid dialogue
but then the aligned decisionand the execution is not easy
work.
I still look back through myjourney in SIG.
I also led a sales team as well, and being able to pour all the
forces towards a common goal isan incredible skill set to have
(35:43):
and one that does take time todevelop as well.
Matt Pillar (35:45):
I would say yeah, what were some of the key?
I mean, it's an important point.
I'm curious about some of thesort of key experiences that
have contributed to that skillset.
Rick Modi (35:55):
Yeah, and I use the word sales can be sometimes
misinterpreted In biotech.
You have to remember that youare still providing the
opportunity for a patient or afamily to make a medicine choice
that will affect their healthright, so I always call it
education.
Having gone through the salesexperience, you set the right
(36:18):
expectations of how you want anindividual or an individual team
to behave, the common goal thathe or her or that team has, and
then to be able to work side byside with that individual and
make sure expectations are metand the common goal is achieved.
That's the process and the whatI would say the dynamic that set
(36:40):
up in the world of commercialthat is quite well trained and
exhibited.
So being able to bring thatinto the leadership team and
beyond the leadership team, it'straining, it's development,
it's all those things and it'salso I use the term followership
in a manner in which you haveto be able to craft a vision.
(37:01):
You have to have people.
It's a calling.
You have to have them believein that vision and then they're
jazzed to go and see if it canmake a difference in the world
to these people that arecounting on you that you have a
technology or medicine that canmake a difference in their life.
So that I think is where magichappens in running a company or
running a team or working withpeople.
Matt Pillar (37:23):
So let's talk a little bit about the magic that
Affinia is making happen.
You've got the team, You've gotthe culture.
You're all rowing in the samedirection.
Take us through some recentprogress in terms of the
technology and therapeutics thatyou're working on.
Rick Modi (37:38):
Yeah, it's a momentous year, a very
transformative year.
So over the past many monthsdeveloping capsids that get
genetic cargo to the rightdestination, we focused on two
tissues muscle and the centralnervous system.
In muscle, we focus on skeletalmuscle and cardiac muscle.
So we have capsids that get toskeletal muscle in all the
(37:59):
diseases that are there forskeletal muscles, including
douchan muscle dystrophy,myotonic dystrophy and others,
and we have a set of capsidsthat do the same thing for
cardiac muscle as well.
In the cardiac muscle there'smore and more genes that are
being identified that explainwhy people have certain heart
disease that can.
This can be heart failure.
This can be the heart gettinglarger, hypertrophic
(38:21):
cardiomyopathy.
This can be everything else.
So we are focusing for ourinitial indication and program
or lead program as we call it ona genetic disease of the heart.
That gene that is affected iscalled BAG3.
The resulting impact on thepatient is they have heart
failure.
Now, many people have heartfailure, but they shouldn't be
(38:42):
getting the heart failure intheir 20s and 30s.
That's what happens to theseindividuals.
The BAG3 gene produces thisprotein called BAG3, which is
key to the heart cells beating.
So imagine if the cell only hashalf the protein, of course the
heart cell cannot beat and theindividual ends up having heart
(39:04):
failure.
With the CAPSID and thedelivery method that we have, we
can easily package in thisbag-free gene.
It's full length, it's fullyhuman one dose, simple IV
infusion and we've shown inanimals that the cardiac cell
starts beating healthily againand the cardiac function is
(39:24):
restored back to normal.
We scaled up those studies tothe higher species, the
non-human primate studies, as wecall it, and we've transferred
that technology to ourmanufacturing partner, forge
Biologics, and they'll scale itup to the desired scale they
need.
So this year we plan on filingan investigation on a new drug
(39:45):
to the agency.
We've met with the agencyalready.
Initially that filing willhappen in the fourth quarter of
this year and this is a diseasewhere our preclinical data shows
us that we can actually getefficacy results very quickly.
So we hope to come in the firsthalf of next year and to show
that what we've seen at theanimal studies we can actually
show in people.
Matt Pillar (40:06):
Yeah, that's pretty wild.
That's fantastic.
I mean, you use the word easily.
You know, we showed that wecould do this easily.
It seems like you know nothing.
You even said like nothingcomes easy.
So how easy really was it.
Rick Modi (40:21):
The jury will be in the clinical results for sure.
Matt Pillar (40:23):
Yeah, we've selected this.
Rick Modi (40:25):
I spoke about decision-making and diversity of
opinion.
I hope that reflects how muchdebate we put into selecting
this indication.
The biology of this disease iswell blown out with human data.
So in humans, people have shownthat when bag three protein
levels in the cells are lower,that cell doesn't beat fast
enough hard enough.
(40:45):
In humans, people have shownthat when the MAG3 is not
functioning properly, the peopleend up having heart failure and
the difference is verypronounced and very quick.
And the animal model that we areusing almost identically
mirrors the human disease, fromthe genetic defect to the
(41:07):
molecular design behind it, tothe exhibition of the loss of
cardiac function and then, forthat reason, the early death.
A quarter of these patientshave a heart transplant.
Of course, in these animalsthey don't do a heart transplant
, so that the animals end up,you know, unfortunately dying
until we give them this genetherapy and then, as I mentioned
(41:28):
, the cardiac function is lost.
Will it be easy?
No, have we done all the thingswe could to make sure that we
have the risk?
This program?
Absolutely yes.
So I'm super excited aboutpushing it forward into the
clinical trials and showing thatwhat we're seeing in animals
will be seen in people as well.
Matt Pillar (41:46):
With all the safety measures of depending to that
account yeah, well, uh, whathave you found in terms of the
investment community's appetitefor, for what, if any, is
working on?
You know, the gene, genetherapy space is one of those
ones that's been subject to, youknow, ebbs and flows, peaks and
valleys in terms of investinvestment, general investment
appetite.
Rick Modi (42:07):
Uh yeah, gene therapy is not regarded as in favor, as
I will call it or invoke Again.
There is eventual for investorsentiment on these things.
I will say there is really goodsegregation between gene
therapies that use conventionalcapsids and gene therapy
companies that are developingnew delivery methods, like us,
that are capsids that actuallysolve the issues with
(42:27):
conventional capsids.
The last race that we did wasin April 2021.
So it's four years out sincethen, which is amazing.
That was a series B.
The reason we've been able tocontinue the company without
doing another fundraising untilwe do one in the near future has
been because we have deliveredthe capsids through a business
development deal that we hadwith Vortex, and those have been
(42:48):
earning the maximum financialmilestones that we could have
wonortex, and those have beenearning the maximum financial
milestones that we could havewon.
So that's been steadying thecompany financially.
On those points, thereceptivity is really good with
this indication.
There are tens of thousands ofpatients unfortunately affected
in the US alone.
It's a disease where there isno specific disease-modifying
therapy.
Even in our dialogues with theFDA, we believe that the data
(43:11):
was received as being verycompelling and our sentiment
from the investors so far hasbeen very encouraging that this
is exactly the type ofindication that they would like
to see, where we've shownefficacy, safety.
And also in head-to-head studies.
Differentiation from othersmight be doing down the line in
this disease.
So we will do our best withthat Fundraising.
If any CEO tells you, by theway, it is a good market out
(43:34):
there for fundraising right now,it is not, I can tell you right
away, straight on that.
Matt Pillar (43:39):
I mean, we're in a place right now where the
message is mixed obviously right, like people are putting the
shiny stuff out there, but it'snot necessarily always really
shiny yeah.
Rick Modi (43:48):
Yeah, yeah.
I would say that things that dohelp is the data speaks for
itself, and our prior trackrecord as a leadership team also
speaks for itself.
I think, where the dialoguedoes happen is in the three to
four years timeframe ago.
There was certainly,unfortunately, a lot of hype, so
the valuations were moreinflated than they likely should
have been in retrospect at thetime.
(44:09):
Yeah, so of course there willbe a reset in just the market as
it has been going unfortunatelyfor the past two or three years
.
Matt Pillar (44:20):
Yeah, you mentioned your partnership with Forge
Biologics.
I'm curious about what the planmight look like moving forward.
I don't want you to make toostrong forward-looking statement
, but let's fast forward and saythat those tens of thousands of
patients who could benefit fromthis therapy have the
opportunity to benefit from thistherapy.
Let's just use those words.
This is a space where you knowmanufacturing and access and
(44:45):
distribution have presentedchallenges historically.
Access and distribution havepresented challenges
historically.
How do you feel about thatenvironment and its development
between now and that point?
Right Like, do you, do you have, do you have reason to believe
that there's commercial,commercial manufacturing
(45:07):
opportunity in a in a way thatis going to create accessibility
for patients for therapies likethese?
Rick Modi (45:14):
Yeah, really good question.
So what I didn't mentionearlier is one of the other
areas that we spent significantinvestment in the technical side
is also manufacturing Withinour own company.
On site we have a processscience development lab that
goes all the way up to 250liters.
I mentioned to you that one ofthe individuals we brought into
our company, the head ofmanufacturing, came from AVEXIS,
(45:36):
where he's done gene therapymanufacturing to a very good
level of depth.
So the new technology that wehave developed, which is a
proprietary plasmid design toget a little bit into the
technical depth there,proprietary plasmid design, to
get a little bit into thetechnical depth there allows us
to improve our yields by 10times and also improve the
quality of the product.
So we have tech transferredthis to Forge Biologics.
(45:59):
They have replicated theresults.
The results are good even intheir hands, which is again
really good science, and theamount of scale that we are
using at Ford Biologics, similarto ours, is much smaller than
what other companies might haveto use if they did not have this
proprietary plasmid design.
So we are to give you a reallygood example even to go into our
(46:23):
phase one, the first in humantrial, we will use only a 50
liter scale.
Many companies would use a 250or a 500 liter scale.
So that gives us really highconfidence on both the ability
to have the capacity to provideaccess to these patients but
also to manage some of the costof goods sold as well.
(46:44):
When you take into account adisease such as backfeed I did a
cardiomyopathy and you considerthat about a quarter of them
unfortunately require a hearttransplant, the health economic
argument for a disease like thatand the cost on that individual
, that family and overallsociety and the payer, the
budget impact, as they call itis actually really really high.
(47:04):
A heart transplant is millionsof dollars, unfortunately, right
, not to mention the subsequentcost that comes alongside a
heart and immunosuppressantindividual as well.
So again, when we select thesediseases, we're also very
conscious of the societalbenefit and ensuring that we
have both the benefit risk of agene therapy but also a strong
(47:25):
health economic argument tosupport it as well.
Matt Pillar (47:28):
Yeah, yeah, what would be an investor's
trepidation around, like I mean,if you think about it, just you
know, at a baseline level,simply fundamentally we're
taking a technology that hasshown its merit.
It's demonstrated its merit.
There's the potential to takeit out of ultra rare indications
(47:52):
, where you know, as an investoryour benefit, your payback
might be limited into more broadpatient populations, broader
indications, bigger patientpopulations, and you know, to
your point there's a financialequation that's not going to
make it.
Now we won't speculate on whatthe price tag might be, but
(48:16):
certainly competitive to, orbetter than, a multimillion
dollar heart transplant.
So what's the concern?
What would you say is thebiggest concern right now?
Rick Modi (48:26):
I would not say the investors have a concern.
The Receptive is really goodfor the MAG3 dilated
cardiomyopathy program as anexemplary instance of where gene
therapy is a really goodsolution to it, with capsules
such as ours, which gets toliterally 100% of heart cells.
Many investors, unfortunatelyfrom the I'm speaking secondhand
(48:47):
from the dialogues with them-I'm not myself, of course, but
for many investors.
Unfortunately, the last fewyears have not been good, yeah,
especially for the folks thatare in the life science focused
industry, because thegeneralists have benefited from
higher interest rates and otherareas beyond the lifetime sector
.
So for the ones that arefocused on the life science area
, they find more comfort withclinical programs, the programs
(49:12):
that are already in the clinicand where the readout is in the
next, say, six, months.
Matt Pillar (49:17):
Right.
Rick Modi (49:17):
In the case of Afinia , the IND is this year and the
readout is in the early part ofnext year.
So that is part of the excitingpart is that by the time we do
the subsequent financing, it isjust around the corner.
But they're being selective.
Certainly for more clinicalprograms is the main thing.
Sure, I do believe the way thatgene therapy is evolving I think
(49:39):
similar to what biologics wentthrough when I was launching
Remikade decades ago I believethe receptivity and the
perception and the evaluation ofa gene therapy will become
modality agnostic.
It's another potential medicine.
It's another potential patientcommunity.
It's another potential for aninvestor.
(49:59):
The return on investment right.
The fact that it's a genetherapy is perhaps a secondary
point, right.
And so they will look at thescience.
They will look both in terms ofthe human biology for the
disease and then the preclinicalresults that have been
generated by the company forthat particular disease, the
dialogues with the agency, theFDA, and then make a decision on
whether that is something thatfits into their strategic fund
(50:20):
that they are putting money,that they're deploying money for
.
Matt Pillar (50:23):
Yeah, interesting what's been on your agenda here
this week.
Rick Modi (50:30):
Interesting what's been on your agenda here this
week.
So I'd say about a good halfmeetings are business
development meetings just bigcompanies that like our
technology, that also like ourprograms and pipeline as well
and are curious about what we'rewilling to license to them.
And then the other half areprimarily investor meetings.
Again, as I mentioned, it'sbeen four years since we made
the last round.
(50:50):
We've been producing some greatprogress and we should press
solutions for them, so there'ssome inbound interest in would
like to hear more about you whenI use your next fundraise, you
know might make sense to speaknow and then some are, I would
hope such as yourself.
So being able to speak toyourself and just spread the
word out and also share theleadership journey has been also
(51:13):
amazing as well.
Matt Pillar (51:14):
Yeah, it certainly has.
I mean, it's a great story.
You've got a great story.
The work you guys are doing isappreciated.
We'll be paying close attention.
So you've got some pretty biginflection points coming up here
in the next year or so.
So hopefully you'll be willingto come back on the show when
there's some data to share andprogress to share.
Absolutely.
But I've appreciated the time.
(51:35):
I know it's a super busy weekand I'm glad you made some time
for the business, biotechLikewise.
Rick Modi (51:39):
Thanks for having me over and wonderful.
Matt Pillar (51:41):
Yeah, so that's Rick Modi, ceo at Affinia.
I'm Matt Pillar.
This is the Business of BiotechJP Morgan edition.
We will drop again next Monday,I believe, with another JP
Morgan edition, so subscribe.
Wherever you listen to podcasts, make sure you watch the
videocast at Bioprocess Onlineand Life Science Leader under
(52:04):
the Listen and Watch tab, andwe'll see you next week.
I'm Matt Pillar.
This is the Business of BiotechJPMorgan 2025 edition, and I'm
here with a man who knowsadversity and challenge quite
well Rick Modi.
Born in Kenya, 17 years inKenya.
Then he decided to come to theUnited States of America.
This is a story we're going tohear very shortly His decision
(00:25):
to come to the US and earn hisdegree in pharmacy and then
launch a career in life sciences, leading up to his leadership
now at Affinia Therapeutics,where he serves as CEO at
(00:45):
Affinia Therapeutics, where heserves as CEO, so we're going to
get right into that story.
We're here, by the way, we'rehere at the offices of Alston
and Bird, in partnership withAlston and Bird, and I'm very
thankful to Alston and Bird, avery reputable law firm in the
biotech space.
If you have any needs for legaladvice in biotech, alston and
Byrd is the place to be, socheck them out.
Rick Modi (01:07):
But yeah, we're here and I want to start right there.
Matt Pillar (01:09):
I want to hear the story about what led up to your
decision to come to the US andearn a pharmacy degree in Iowa.
Rick Modi (01:22):
Sure Matt.
So first thank you for havingme on here as a guest.
Very humbled to be here.
Pleasure to meet you.
The story is very, veryinteresting.
So I was born in Kenya.
When people meet me, by the way, say you don't look Kenya.
Matt Pillar (01:35):
What is?
Rick Modi (01:36):
your heritage.
I'm Asian Indian by heritage.
Kenya is a British colony.
In those days there were a lotof Indians that they brought to
Kenya to do work and they stayedover and started shops and
families and kids like me at thetime.
So I spent 17 years in KenyaAmazing journey living in a
third world country.
People talk about survival ofthe fittest.
Physically, this is survival ofthe fittest because you end up
(01:59):
getting malaria and you surviveit.
It's survival of the fittestbecause there's not enough room
in the next classroom and if youare not, you know working hard
enough you get cut out prettyquickly.
But yeah, I always wanted toget into the medical field.
I mean it was pharmacy,physician, those types of
careers.
And I looked up again.
Many people in these thirdworld countries look up to the
(02:19):
US and say wow, great education,land of opportunity.
So I always had this vision andwant and desire to be in the US
.
The pharmacy school in.
Iowa was one of the top five, sothat's how I ended up choosing.
Matt Pillar (02:31):
Iowa.
Rick Modi (02:32):
It was also one of the cheaper cost of living and
for somebody coming from a thirdworld country to a very
well-developed first worldcountry, cost of living is a
major factor.
Matt Pillar (02:41):
Yeah.
Rick Modi (02:42):
So I got admitted in January in Iowa.
So Kenya is on the equator,beautiful weather, and they use
centigrade, not parametrized.
But we'll come back to that atsome other point Going from
beautiful tropical weather to inthe dead of winter.
Iowa was one story, but I alsogrew up vegetarian and I only
(03:06):
had two food choices in Kenya itwas either corn or beef.
You can imagine how long, muchlonger, I was vegetarian after
moving to Kenya actually.
Matt Pillar (03:14):
Yeah, that's wild.
So you talk about growing up ina third world country and then
making that transition.
Aside from the climate and yourculinary options?
Were you prepared, coming outof an education in Kenya, to
come over here and I mean, wereyou educationally equipped to?
I mean, obviously you got in,but I'm just curious about that.
Rick Modi (03:37):
Sure.
So the education in third worldcountries is actually very
buttoned up in the case of Kenyabecause it was a British colony
way back when they followed theBritish system.
So the British system hasordinary levels, advanced levels
.
They follow the generalcertificate of education, which
many people in the US would notknow what it is, but they are
essentially examinations thatplace people.
Matt Pillar (03:59):
And to give you an idea.
Rick Modi (04:02):
My high school education in Kenya gave me 32
credit units for the universitylevel in the US, so I got a head
start on that and also givesyou an idea of what the standard
of education in Kenya was.
You have to watch your tail off, to be honest, in a third world
country, and the standards arereally, really good.
I was fortunate enough to alsogo into an English speaking
(04:24):
school, which also helped me getpast TOEFL and all these other
tests that you have to gothrough to come to the US.
Matt Pillar (04:32):
Yeah, what did your parents do in Kenya?
Rick Modi (04:34):
No, I was a stay-at-home parent.
My dad was in the bankingsector and when I tell people in
the US who was in the bankingsector, they think oh, it must
not be banking.
No, he was a banking teller anda cashier initially and then
worked his way up into the loandepartment and such, but they
were hardworking people madeends meet, just like hardworking
(04:55):
people do Instilled in me workethics, integrity all the values
that even to this day I lookback and I'm so thankful to my
parents for imparting on me.
They did fund part of myeducation but the rest was
classically.
you know people that come to theUS.
They get a job in a lab workingin the pharmacy school, which
is what I did.
(05:16):
And then also, you know, inaddition to doing the pretty
deep and extensive curriculumthat pharmacy actually requires
as well, it was a hard work, itwas fun Many people, by the way,
that come from other countriestoo.
One of the great things aboutAmerica is also it's a fun,
loving place as well.
So, like every other collegekid, I also had my part of fun.
(05:36):
You know going out to SouthPatrick for like spring break
and you know doing all thethings that college kids do and
are probably not supposed to bedoing.
Matt Pillar (05:42):
But that was part of the experience.
Yeah, where did the interest inlife sciences come from?
I mean, your mom's astay-at-home mom.
Your dad was a bank teller inKenya.
You know, was it yourexperiences in Kenya, with some
of the health problems overthere and diseases that Kenyans
face, what was sort of thenucleus of your desire to put
(06:05):
the work in to become apharmacist?
Rick Modi (06:07):
Yeah, that's a good question.
In some countries, such asKenya, for example, there are
some fields that are looked uponwith very deep respect.
The health sciences is certainlyone of them.
So my initial career choice wasactually becoming a physician.
Yeah, Help patients do right bysociety, all those things.
Pharmacy was my stepping stoneto become a physician and just
(06:30):
to be very good in pharmacy andended up having a career in
pharmacy.
I decided to stay put in thatand I'm very happy that I did.
Eventually went back tobusiness school actually for my
graduate studies, but plan A wasbecoming a doctor, to be honest
, and it was looked in with highregard.
Um, my kids, by the way, are intheir 20s right now.
I have twins, twin boys, andthey, like many kids on that age
(06:53):
, they're, they're working rightnow.
But also wondering is thistheir end stage career?
Will they switch careers?
And I tell them, go and havelike, do things that you enjoy
doing and and it will take careof itself.
It's easier said than done,right, it's easier at this point
to look back and say, yeah, Ishould just follow my heart and
do the things that I enjoy doing.
Of course, in the moment whenyou're debating debating between
(07:15):
a first career or a pharmacistor a physician, or going back to
grad school for business uh, inthe moment those are really
difficult decisions.
But I look back and I say, ifyou work hard and go with the
things that your naturalstrengths are, you should be
okay.
Matt Pillar (07:31):
Yeah, yeah.
No, I can appreciate that.
I have a 20-year-old and an18-year-old, you know, and the
pressures that they receive fromevery influence beyond their
family, you know, to makechoices and choose tracks.
It can be overwhelming forthose kids sometimes and you
know, as dads we sort of have togive them that safe space to
say, look, you know, we've beenaround and it's not all riding
(07:53):
on the decision you make today.
Right yeah, so yeah, gettingback to your career trajectory
the pharmacy to pharmatransition the, the pharmacy to
pharma transition.
Rick Modi (08:09):
Tell me, tell me how that came to, came to pass.
Yeah, so after graduating fromiowa, I, I went to, I came to
california.
We're in california right now.
So I came to california and did10 years in a hospital pharmacy
.
Uh line of work um, it wasgreat because it anchored me.
Uh, these were patients in the,the ICU, where pharmacists are
called upon to dose antibiotics.
These were babies bornprematurely.
The pharmacists were called into start IV nutrition.
(08:30):
As an example, you were on thefloor side by side with
physicians and nurses andsometimes patients and parents
to lend your expertise as ahospital pharmacist.
It was great up to a certainpoint I started getting into
administration within thathealthcare system and then I
began liking the business aspectof things as well, the
administrative part and some ofthe entrepreneurial things that
(08:53):
also come from becoming apharmacist as well.
Matt Pillar (08:56):
Was that part of your pharmacy training, Like
when you were in pharmacy school?
Is there a fair degree of like?
You know, we're going to equipDr Modi to become potentially an
independent pharmacist, orwe're going to equip Dr Modi to
become potentially anindependent pharmacist we're
going to teach some business.
Rick Modi (09:08):
A little bit, I would say, but not that much.
Most of the curriculum isgeared towards science.
Yeah, I'll say the thing that Ilearned the most, both from
pharmacy school as well as thedecade as a working hospital
pharmacist.
They call it SOAP, S-O-A-P.
It's an acronym that physiciansuse quite a bit when they
(09:30):
evaluate patients.
So the S is for subjectiveassessment, the O is for
objective assessment, the A isfor assessment itself, and then
you apply them.
Many people in the businessworld sometimes draw an analogy
between the business situationand a patient.
The treatment is worse as anexample right, it's a benefit.
(09:51):
Risk is an example for adecision you're making.
Those are the skills that Iwould say that I learned a lot
more, that were more applicableto the business world.
But it was very similar in thatsense, you take metrics that are
non very subjective, you addmetrics that are very objective,
quantitative, and then you makean assessment and then find
(10:12):
it's a very analytical field,the pharmacy field, and those
are the skills that helped me,but more than anything I would
say was more transitioning frommany people with a technical
expertise start growing up inthe ranks and then end up being
in a business type of a role.
I began a second love in thesecond part of the business
(10:32):
world Right, and that's where Icompelled.
I got compelled enough to say,well, wouldn't it be great to go
back to business school and geta graduate degree and do all
these things that I'm seeingwith new drugs in the hospital,
on the investigational ReviewBoard, on the Pharmacy and
Therapeutics Committee?
Wouldn't be good to apply whatI'm learning here into bringing
these medicines from the otherside right?
Matt Pillar (10:54):
Yeah.
So what did that movement tell?
You went back to businessschool, right?
Did you get your MBA?
Is that what you did?
Rick Modi (11:00):
I did.
I went to Penn with two little,the twins that I referred to.
Until at the time, they werebarely not even two years old.
Matt Pillar (11:08):
So Iowa to California, to Philly, to Philly
yeah.
Rick Modi (11:12):
And we, literally we, sold everything.
The wife was, of course, youknow not, not excited about it
but came along for the ride as Iwould say yeah, and.
And we put the strollers on thetop of the van and moved cross
country and the next two-ishyears year and a half two years
everything was at risk.
(11:33):
To be honest, full-time,student, full-time yeah, I did
it the hard way, it's probably arecurring thing in my life,
whether it was planned or not.
We can do it at some point, butI did it the hard way.
I quit the job.
My wife quit the job.
She was a working nurse as well, and we were both essentially
just living on loans and goingfull time.
(11:53):
I was going to full time andshe was taking care of the kids
initially.
Matt Pillar (11:57):
Yeah, wow, you have a great wife.
I would agree.
Rick Modi (12:01):
We're coming up on 30 years now.
Congratulations.
Matt Pillar (12:04):
Yeah.
Rick Modi (12:10):
So you stick it out full-time at Penn, get your MBA
and then what?
Another interesting story andit always goes back to it's
never planned, at least for me.
I looked at banking coming outof business school.
Really it seemed like bankingwould be a good career.
Everybody was talking aboutbanking as a place to be.
I looked at consulting because,again, people with MBAs look at
consulting as well.
Interestingly, theopportunities that came to me
(12:33):
were banking and consulting.
Actually, in some cases theywanted to interview me.
The ones that came to me werebiotech and pharma.
Yeah, and I ended up in a verysmall company called Centimore.
This was still in Philadelphia.
This was still in Philadelphia.
This was still in thePhiladelphia area, exactly yeah.
So, thankfully we didn't have tomove again my wife was happy
with that part and Centmor hadjust been acquired by Johnson
(12:56):
Johnson and they were launchinga drug, a biologic that is quite
well known now, of course,called Remicaine, but at the
time it wasn't that well knownand it was their first
indication at the time ofCrohn's and rheumatoid arthritis
.
And of course I had done mydiligence in looking at the
science.
But my first week was theeye-opener for me, that sealed
the deal and that I had made theright choice.
Matt Pillar (13:17):
Actually, and what happened in that first week.
Rick Modi (13:20):
So as happens in, many of these companies, when a
drug is approved, it's a bigcelebration.
Typically in biotech and pharma, the odds are against drugs
getting approved.
The science in the end are somany times it's just a very,
very tough and challengingpublic science and business.
Right With the approval ofRemicade, they got the company
together and did a companymeeting and as part of that
(13:42):
company meeting celebrationwhich is my first week, by the
way, so I'm climbing joiningthat company was just impeccable
.
Very fortunate, there was awoman on stage in her 50s and
she was a mom with two kids andthey wheeled her onto the stage,
but she got out of thewheelchair and her message to
(14:03):
the company was I was in yourclinical trial as a patient who
was involved.
I've been taking Remicade, thisinfused biologic that you all
have developed, and I can nowget up and my walking ability is
improving and I can now hold mykids.
And our message to us was thankyou.
And as I was sitting on thestage, I had no part of this.
(14:26):
I didn't develop the drug.
This is my first week, but tobe a part of that industry, a
part of that company, a part ofthat journey and being able to
say wow, I couldn't be a part ofmaking such a big difference.
That's what sealed the deal forme to say wow, if these
medicines work, the effect sizeof somebody not being able to
(14:47):
walk and then being able to getup and hug their children that's
a private moment.
So that was really like a baby,just to be already open.
Matt Pillar (14:53):
Yeah, for sure.
So how long did you stay withSenecor?
I was at Senecor for sevenyears.
Rick Modi (15:00):
What was your role there?
I was on the marketing,commercial side.
It was great because I couldtake everything I learned when I
was in the hospital all thepharmacy science that I learned,
all the conversations withphysicians, with patients, and
then the application of thebusiness aspect of things and
then be able to educate folksand be able to also place a
(15:20):
therapy like Remicade in theproper place, like in the
treatment paradigm.
That's what I believe biotechand also commercialization is
about the right patient choice,the right positioning and, for
that matter, also the righteducation on the benefits and
the risk of these products.
In those seven years welaunched Remicade in five
different indications.
It might have been sixRheumatoid arthritis is one.
(15:43):
Crohn's disease, ulcerativecolitis, psoriasis.
Psoriatic arthritis it wasdrinking out of a virus.
Literally.
It was amazing learning.
We made a huge difference andwe continued doing lifecycle
management obviously kind of gotup as well.
Matt Pillar (15:57):
Yeah.
So at what point did you startto get the entrepreneurial itch,
like you're?
You know Senecor, johnsonJohnson.
You're in a pretty establishedrole as an established company
doing commercial work for anestablished product.
You know where does this desireto move?
Rick Modi (16:17):
way back to the other side of that continuum in
biotech come from.
Yes, sometimes I believe it'sjust a natural journey For me.
Centercore led to MediMune,another biologics company.
Matt Pillar (16:31):
Again, MediMune was already part of AstroSumicat.
Rick Modi (16:33):
So we were a subsidiary in launching,
building up the pipeline andlaunching additional drugs.
But in MediMune I started doingmore corporate strategic type
of initiatives, including one onbehalf of us or something like
that as well.
So that's where what I wouldsay good judgment skills became
important, and more at thehigher level.
These are decisions aboutfranchises, about size, about
(16:55):
indication selection, but it wasstill working through
governance.
It takes a long time to gothrough in big companies,
various governance meetings.
It takes a long time to gothrough, in big companies,
various governance meetings and,as I developed, these skills
(17:17):
more the ability and the courageto say I can do this in a
smaller setting, became moregermane and more attractive.
So, guess what?
I moved back to California fora smaller company called
Intermune All the way back, yes,In the Bay Area and this was a
company that was developing atherapy a small molecule this
time called Aspirin in a diseasecalled idiopathic pulmonary
fibrosis, and we brought that toapproval and launched that drug
(17:40):
.
And then eventually Rocheacquired the company.
But that company had beenworking on Esprit in the past.
One phase three trial had beenpositive, another one had been
negative and when I joined theywere doing the third trial to
prove or disprove whether thedrug would really work in this
population.
So I was taking significantrisk.
(18:00):
Again I look back and I say,wow, isn't it great that we
brought another therapy topatients and you know, ones that
are in need with idiopathicpulmonary fibrosis.
After that I haven't lookedback at no big company since
then.
It's been all entrepreneurial,all small companies, including,
obviously, you know since thenAvaxis and then now Athenia.
Matt Pillar (18:19):
Yeah, yeah.
So tell me about that story.
How did your, what was yourexposure to it?
Finneas that led you to CEOchair there?
Rick Modi (18:28):
Yeah.
So I think in some cases myjourney is quite typical.
In other cases it's atypical.
What I mean by that is theproving grounds in big companies
, where skill acquisitionhappens, is quite typical.
And then the graduation fromthere might not seem like
graduation at the time and thenthe graduation from there it
does seem like graduation at thetime.
But the graduation from thereto smaller companies, where then
(18:50):
you start expanding your wingsand get into higher roles and
more, bigger responsibilities,is pretty typical and one that I
have enjoyed because when I'vegone into the smaller companies
I now believe I'm anchoredenough and I am courageous
enough to make these decisionsright.
So when I was at Avexis webrought another gene therapy to
patients called Sotresa.
(19:11):
These are kids with spinalmuscular atrophy.
We give them this one-timetherapy.
It's infused as an IV infusion,we give it to them shortly
after birth and the disease iscalled floppy baby syndrome.
It's hard-running enough wheremany of these babies cannot
really function.
They never get the ability tostart walking and such, and in
(19:34):
many cases they can actuallypass away before the age of two.
So it's one protein that'smissing, the SMN protein.
So with the gene therapy wedeliver, using a capsid, this
missing gene and the gene goesto work and these babies are
safe.
So being a part of that teamwhere we brought that therapy to
(19:55):
that patient community andbeing able to help those parents
and those kids they have theirown careers now it was
life-saving for them andlife-changing just to be a part
of that team.
But that's also where I realizedthis particular technology can
be useful in so many otherdiseases.
The problem, however, is youcannot get all the different
(20:18):
types of genes to make thesetypes of curative benefits with
the conventional capsules thatare available out there.
So when I left Avexis, thatcompany was bought up by
Novartis.
After we got the approval, avery good colleague of mine, ed
Mothers, who's a very well knowninvestor with new enterprise
associates, nea that I'd beenworking with at MetaMune
(20:41):
actually way back when, hadapproached me to see what I was
doing and I had consideredmultiple different CEO roles.
But he said hey, I know ascientific leader who is in the
gene therapy space and is tryingto start a company.
That gentleman's name is LukeVandenberg and quite well known.
He co-invented one of theinitial capsules, c89.
So he introduced the two of us.
(21:03):
It was a phone call in a lateevening.
It was supposed to be 30 minutesand we just spent talking into
the evening.
We met in person later thatweek and he told me what he was
trying to do and I had neverstarted a small company before,
forget like a startup.
But I loved what he was tryingto do.
It was gene therapy coming off.
(21:24):
Just seeing what gene therapycould do with the kids in spinal
muscular atrophy, I was hookedand he was doing exactly what we
believed, what I believed thelimitations of interventional
capsules were.
So I took the risk and I saidI'll partner with you.
I haven't done a startup before, ever.
There's no money around thetable right now.
I understand the science enoughto realize.
(21:45):
Of course it's going to be aslog, as I will call it, just
like everything else in science,but sure, we we connected and
we're now five years in.
Matt Pillar (21:54):
Yeah, all right.
Well, there's a lot of severaldirections we can take, all
right.
So you're sitting around thetable and you decide that you're
going to get in on thisopportunity, this project, if
you will.
Right, what did you?
You'd never done a startupbefore.
So what was like?
What was job number one for youpersonally to say, okay, like
(22:15):
we're going to make a companyout of this, I need to.
X.
Rick Modi (22:19):
Yeah, it's a good question.
With any startup, the firstthing is do you have the money?
Can you get the money?
So I to just do the initialwork was six months of work just
figuring out the strategy,figuring out the science,
putting the pitches together.
There's no pay in that.
Matt Pillar (22:37):
You're on your own, yeah, but you and your wife
have been there before.
Was she as receptive to it thistime around?
Rick Modi (22:47):
By the way, I love my wife.
She still works as a nurse,which she is receptive to at
this time around.
By the way, I love my wife.
Matt Pillar (22:50):
She still works as a nurse.
Rick Modi (22:52):
So she enjoys the same things that drove me all my
life the patient interactions,knowing that we could be a part
of this community, knowing thatwe could leave a legacy if it
does work out right.
So that was the again I'll say,the anchoring.
That's the mission, that's themotivation, right?
So, yes, there's no pay for afew months, but there's the hope
(23:14):
, the conviction and the courageto say, well, we could do
something here.
So in those six months, you'rewriting personal checks to say I
need a few more people to getsome work done.
I need a facility which youstart with a shared space
initially, but then you alsoneed labs to start.
So all that was initially apersonal check, while we were
(23:36):
trying to travel funding forwhat is called a seed financing,
right, yeah, so we startedcalling on investors.
I'm again very, I'll say,fortunate, lucky, blessed, but
some is just being there at theright time at the right place
sometimes, where the priorcompanies and the successes that
we had in bringing therapiststo patients also rewarded
(23:58):
shareholders and investors.
Right, so I had now afollowership that I could call
on and say look, this is whatwe're trying to do.
Would you take the meeting?
Let me walk you through whythis particular company could be
a good fit for you.
Right?
So we did that and did the seedfinancing initially, and then
the series A, but those were ourdays.
Sure, you said this was fiveyears ago.
(24:23):
This was 2019.
And of course, you and I knowalso what happened in 2020, this
was 2019.
And of course you and I knowalso what happened in 2020, you
know, called the pandemic,unfortunately, Our friends at
Alston and Byrd set us up withsome amazing space to record
during JPM week.
Matt Pillar (24:42):
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(25:25):
commercial launch.
Learn more at alstoncom andtell them you learned about them
on the Business of Biotech,yeah.
I mean pandemic aside, I wasgonna ask your perspective on
where we were on this sort ofdelivery vehicle fervor in 2019.
(25:47):
Like there's a lot of attentionbeing paid to delivery
mechanisms for gene therapiesand you know how we're
navigating them to the righttissues In 2019, what was it
sort of you know early days forthat, for exploration of that,
or was it in full swing?
Rick Modi (26:05):
It was a bit of both in the following ways in full
swing it was a bit of both inthe following ways.
Conventional gene therapy wasan uptick, so Avexodus was
acquired by a big company.
There were a few other dentistswas acquired by a big company,
right.
So there was a belief thatconventional capsules would be
good enough and it would be copyand paste very, very easy Again
.
Biotech is never easy and pastevery, very easy.
(26:25):
Again, biotech is never easy.
So there did be at the point itwas good but it didn't last
long where people realizedconventional capsids will not
cut it and that developing newcapsids would be the solution to
that.
Again, as often happensincluding me I thought
developing new capsids would beeasy.
It was a journey, so again ittakes.
(26:48):
You think it's going to be donein months.
Sometimes it takes years.
You think the first indicationyou select will be S-lambda.
Sometimes it's not the firstindication, it's the second or
the third choice, right so to beable to persevere during the
time.
It happens in every biotechcompany, maybe not the first
time, but maybe the third or thefourth time.
But this is biotech.
The odds, unfortunately, areagainst drugs getting developed
(27:10):
and getting eventually toapproval.
So those early days was veryinteresting with the investor
dialogues, because with somefunds the time horizon just
doesn't match with what thecompany is trying to do and how
long the science is going totake to mature, especially when
you're in licensing somethingfrom academia into industry.
Matt Pillar (27:31):
You need to redo the experiments, you need to
find the right indication andpatient community to serve, and
the translational aspect is verydifferent than the research
aspect of things yeah, so tellme a little bit about your, your
approach to that, like whatwhat's your um, what what's your
risk aversion sort of strategywhen you know you don't
(27:52):
necessarily know what the marketis going to, especially in the
you know you mentioned thepandemic.
I mean you know, pandemic yearswere financially pretty good, at
least early right, and theneverything goes crazy.
So what sort of managementapproach to that risk has
allowed you to persevere to yourpoint?
Rick Modi (28:14):
Yeah, so I call it accumulation of experiences.
As one goes through a career,or maybe life in general as well
, one learns a few things aboutgood judgment.
I believe for a leader, and aleadership team in particular,
that's one of the best skillsets to have.
How do you render good judgmentwhen data can be conflicting
(28:37):
even with each other?
Right, it can be scientificdata, it can be business data,
it can be market, economic, itcan be the fundraising
environment.
So triangulating that backagain to when I was in the
hospital and using the SOAP theSubjective Objective Assessment
Plan is what drives theperseverance and the good data.
(28:58):
In biotech it's easier than, inmy opinion at least, than in big
pharma, where again, thegovernance bodies can be just
more off our track.
So we were able to make thesecalls as we recruited a great
team of experts, coming inpeople from different companies.
I could have brought again thesame people that I'd worked with
before, but I chose not to, andbringing that diversity in
(29:19):
thinking and across functionsallowed us to take in stride
whatever circumstances that werethere, and that included the
pandemic.
So, yes, from a financingperspective, there was more
money flowing in the era, butfrom an operational perspective.
That was really, reallychallenging for the people that
were affected and also for theleadership that still had to
deliver during that time.
(29:39):
So those things just came withall the prior circumstances that
we have been through, that Iwas wasn't through.
You can then see patternrecognition.
I've seen a movie like thisbefore.
Let me make some judgment callstoday.
Let's see how it unfolds andthen let's course correct if we
need to, like those were whatsaved the day many, many times
(29:59):
over.
Sometimes it was my experience,sometimes it was, you know, my
colleagues experienced the chiefscientific officer or the chief
development officer, the chiefbusiness officer, the chief
medical officer and the board.
It was the collective that Ialways the chief development
officer, the chief businessofficer, the chief medical
officer and the board.
It was the collective that Ialways say is always better than
the individual.
Matt Pillar (30:13):
Yeah, that's interesting.
Have you always been reallygood at maintaining emotional
control in the face of challengeand adversity In the older days
.
Yes, Less so in the youngerdays.
Rick Modi (30:26):
Not to make it about demographic, but I think
anchoring can come with just andsteadiness is the other word I
would use in what you'redescribing can just come from
again when you've seen moremovies, right type of thing, so
you can take more things instride.
Sometimes it's not justprofessional experience, it can
just be you had a child orsomebody in your immediate
(30:48):
family or passed away.
These things also just putthings into context and
experiment that went bad orsomebody left the company.
You're just able to put thingsmuch more in context and say
wait a minute, this is what Ican control, this is what I can
control and honestly, gettingemotionally distraught about it
is not even a consideration,right, but I wouldn't say in my
(31:10):
younger days I was like that,Like with everybody, we do take
things to heart.
We are an organization, by theway, that is very open to
feedback.
That does take time to develop,meaning we give each other
feedback.
Nobody takes it personally, butI believe that actually is
really important for developingan organization that
continuously learns and thefeedback also provides mutual
(31:33):
steadiness too.
So if I am facing a circumstancewhere perhaps I'm having more
difficulty to take it in stride,I have a colleague next to me
who knows how I react to thatsame circumstance and is going
to help me have more of a steadyhand in that situation.
Right yeah, that samecircumstance and is going to
help me have more of a steadyhand in that situation.
We look after each other and, atthe end of it all, I do believe
people will remember thosememories how we went through
(31:55):
crisis and celebrations togetherand how we reacted in the
moment.
So I do believe that's superimportant.
Matt Pillar (32:01):
Give me a sense of who the we is at this point.
For Afinia, what does thecompany look like?
Yeah, it's amazing.
Rick Modi (32:06):
We're about 60 people overall 60 people.
Each one is handpicked withjust the skill set that they
bring, the achievements thatthey've brought in the past, and
then the cultural aspects ofthings as well.
In the leadership team we haveCharlie Albright as our chief
scientific officer, veryaccomplished individual from BMS
, editas, et cetera.
Laura Richmond, our chiefdevelopment officer she was at
(32:28):
the University of Penn at thegene therapy program, the
executive director there with me, and Manny Mew, our select in
the middle there.
Rami Daud, who, coincidentally,I went to school with at Morton
and then we reunited afterabout 25 years, again very
accomplished.
Lilly, human Genome Sciences,auxilium, etc as well.
And then, most recently I willnot be able to disclose the name
(32:50):
, but we have just hired a chiefmedical officer who will be
joining in just about a coupleof weeks actually from now.
And then Rob May is the lastperson who gets over
manufacturing with theIntervaxxers as well.
Matt Pillar (33:02):
By the time this episode drops that chief medical
officer will likely be known.
Yeah, yeah, congratulations.
Yeah, I mean you.
You highlight theaccomplishments of these folks
that you put together on theteam.
What, what was the you know?
Tell us about the challenge ofputting together, scaling up
that leadership team, you know,to align expertise with the
(33:28):
mission of Affinia.
Was it tough?
Rick Modi (33:32):
It's always tough assembling the right team.
I would say recruiting was good.
I wouldn't call it tough, butperhaps because of the various
companies that I've been at,it's the same diversity in
companies that I was at thatexpanded my network.
That also allowed me toapproach investors but also
(33:55):
build out the board as well.
So between the leadership teamand the board we've had exposure
to I don't know what it is 20or 30 companies.
So you amplify that with theentire network of 20 or 30
companies, or 30 companies, soyou amplify that with the entire
network of 20 or 30 companiesYou're just able to speak with
people, make a phone call andthen get a really good, diverse
(34:15):
set of individuals coming intothe company, both at the board,
the individual at the leadershipand also the part of their
organization as well.
The track record, I would say,helps significantly.
So when I can go in front offolks and say I've been at
CenterCorp, metaimmune,interimmune, amexis, I'm
starting to thin out.
They know these companies arefairytale companies in biotech.
(34:36):
And the number of medicationsand patient communities that got
approved with these drugs is,again, I will just say, uncanny.
You have that many.
And it's the same thing for theother people that have the
pleasure and the privilege ofworking with side-by-side in the
management team.
So it's been good to be able torecruit people from that
perspective.
But assembling the team stillrequires careful thought.
(35:00):
And then the other thing that Iwould also say after you
assemble, getting the rightdynamic is also really, really
important, Because the entire60-ish people that are in the
company are relying on theleadership team for making
co-check decisions, beingaligned, and we debate things
really well, very candiddialogues, but when we have made
(35:21):
the decision that we wantflawless execution right.
So putting a culture togetherthat allows the candid dialogue
but then the aligned decisionand the execution is not easy
work.
I still look back through myjourney in SIG.
I also led a sales team as well, and being able to pour all the
forces towards a common goal isan incredible skill set to have
(35:43):
and one that does take time todevelop as well.
Matt Pillar (35:45):
I would say yeah, what were some of the key?
I mean, it's an important point.
I'm curious about some of thesort of key experiences that
have contributed to that skillset.
Rick Modi (35:55):
Yeah, and I use the word sales can be sometimes
misinterpreted In biotech.
You have to remember that youare still providing the
opportunity for a patient or afamily to make a medicine choice
that will affect their healthright, so I always call it
education.
Having gone through the salesexperience, you set the right
(36:18):
expectations of how you want anindividual or an individual team
to behave, the common goal thathe or her or that team has, and
then to be able to work side byside with that individual and
make sure expectations are metand the common goal is achieved.
That's the process and the whatI would say the dynamic that set
(36:40):
up in the world of commercialthat is quite well trained and
exhibited.
So being able to bring thatinto the leadership team and
beyond the leadership team, it'straining, it's development,
it's all those things and it'salso I use the term followership
in a manner in which you haveto be able to craft a vision.
(37:01):
You have to have people.
It's a calling.
You have to have them believein that vision and then they're
jazzed to go and see if it canmake a difference in the world
to these people that arecounting on you that you have a
technology or medicine that canmake a difference in their life.
So that I think is where magichappens in running a company or
running a team or working withpeople.
Matt Pillar (37:23):
So let's talk a little bit about the magic that
Affinia is making happen.
You've got the team, You've gotthe culture.
You're all rowing in the samedirection.
Take us through some recentprogress in terms of the
technology and therapeutics thatyou're working on.
Rick Modi (37:38):
Yeah, it's a momentous year, a very
transformative year.
So over the past many monthsdeveloping capsids that get
genetic cargo to the rightdestination, we focused on two
tissues muscle and the centralnervous system.
In muscle, we focus on skeletalmuscle and cardiac muscle.
So we have capsids that get toskeletal muscle in all the
(37:59):
diseases that are there forskeletal muscles, including
douchan muscle dystrophy,myotonic dystrophy and others,
and we have a set of capsidsthat do the same thing for
cardiac muscle as well.
In the cardiac muscle there'smore and more genes that are
being identified that explainwhy people have certain heart
disease that can.
This can be heart failure.
This can be the heart gettinglarger, hypertrophic
(38:21):
cardiomyopathy.
This can be everything else.
So we are focusing for ourinitial indication and program
or lead program as we call it ona genetic disease of the heart.
That gene that is affected iscalled BAG3.
The resulting impact on thepatient is they have heart
failure.
Now, many people have heartfailure, but they shouldn't be
(38:42):
getting the heart failure intheir 20s and 30s.
That's what happens to theseindividuals.
The BAG3 gene produces thisprotein called BAG3, which is
key to the heart cells beating.
So imagine if the cell only hashalf the protein, of course the
heart cell cannot beat and theindividual ends up having heart
(39:04):
failure.
With the CAPSID and thedelivery method that we have, we
can easily package in thisbag-free gene.
It's full length, it's fullyhuman one dose, simple IV
infusion and we've shown inanimals that the cardiac cell
starts beating healthily againand the cardiac function is
(39:24):
restored back to normal.
We scaled up those studies tothe higher species, the
non-human primate studies, as wecall it, and we've transferred
that technology to ourmanufacturing partner, forge
Biologics, and they'll scale itup to the desired scale they
need.
So this year we plan on filingan investigation on a new drug
(39:45):
to the agency.
We've met with the agencyalready.
Initially that filing willhappen in the fourth quarter of
this year and this is a diseasewhere our preclinical data shows
us that we can actually getefficacy results very quickly.
So we hope to come in the firsthalf of next year and to show
that what we've seen at theanimal studies we can actually
show in people.
Matt Pillar (40:06):
Yeah, that's pretty wild.
That's fantastic.
I mean, you use the word easily.
You know, we showed that wecould do this easily.
It seems like you know nothing.
You even said like nothingcomes easy.
So how easy really was it.
Rick Modi (40:21):
The jury will be in the clinical results for sure.
Matt Pillar (40:23):
Yeah, we've selected this.
Rick Modi (40:25):
I spoke about decision-making and diversity of
opinion.
I hope that reflects how muchdebate we put into selecting
this indication.
The biology of this disease iswell blown out with human data.
So in humans, people have shownthat when bag three protein
levels in the cells are lower,that cell doesn't beat fast
enough hard enough.
(40:45):
In humans, people have shownthat when the MAG3 is not
functioning properly, the peopleend up having heart failure and
the difference is verypronounced and very quick.
And the animal model that we areusing almost identically
mirrors the human disease, fromthe genetic defect to the
(41:07):
molecular design behind it, tothe exhibition of the loss of
cardiac function and then, forthat reason, the early death.
A quarter of these patientshave a heart transplant.
Of course, in these animalsthey don't do a heart transplant
, so that the animals end up,you know, unfortunately dying
until we give them this genetherapy and then, as I mentioned
(41:28):
, the cardiac function is lost.
Will it be easy?
No, have we done all the thingswe could to make sure that we
have the risk?
This program?
Absolutely yes.
So I'm super excited aboutpushing it forward into the
clinical trials and showing thatwhat we're seeing in animals
will be seen in people as well.
Matt Pillar (41:46):
With all the safety measures of depending to that
account yeah, well, uh, whathave you found in terms of the
investment community's appetitefor, for what, if any, is
working on?
You know, the gene, genetherapy space is one of those
ones that's been subject to, youknow, ebbs and flows, peaks and
valleys in terms of investinvestment, general investment
appetite.
Rick Modi (42:07):
Uh yeah, gene therapy is not regarded as in favor, as
I will call it or invoke Again.
There is eventual for investorsentiment on these things.
I will say there is really goodsegregation between gene
therapies that use conventionalcapsids and gene therapy
companies that are developingnew delivery methods, like us,
that are capsids that actuallysolve the issues with
(42:27):
conventional capsids.
The last race that we did wasin April 2021.
So it's four years out sincethen, which is amazing.
That was a series B.
The reason we've been able tocontinue the company without
doing another fundraising untilwe do one in the near future has
been because we have deliveredthe capsids through a business
development deal that we hadwith Vortex, and those have been
(42:48):
earning the maximum financialmilestones that we could have
wonortex, and those have beenearning the maximum financial
milestones that we could havewon.
So that's been steadying thecompany financially.
On those points, thereceptivity is really good with
this indication.
There are tens of thousands ofpatients unfortunately affected
in the US alone.
It's a disease where there isno specific disease-modifying
therapy.
Even in our dialogues with theFDA, we believe that the data
(43:11):
was received as being verycompelling and our sentiment
from the investors so far hasbeen very encouraging that this
is exactly the type ofindication that they would like
to see, where we've shownefficacy, safety.
And also in head-to-head studies.
Differentiation from othersmight be doing down the line in
this disease.
So we will do our best withthat Fundraising.
If any CEO tells you, by theway, it is a good market out
(43:34):
there for fundraising right now,it is not, I can tell you right
away, straight on that.
Matt Pillar (43:39):
I mean, we're in a place right now where the
message is mixed obviously right, like people are putting the
shiny stuff out there, but it'snot necessarily always really
shiny yeah.
Rick Modi (43:48):
Yeah, yeah.
I would say that things that dohelp is the data speaks for
itself, and our prior trackrecord as a leadership team also
speaks for itself.
I think, where the dialoguedoes happen is in the three to
four years timeframe ago.
There was certainly,unfortunately, a lot of hype, so
the valuations were moreinflated than they likely should
have been in retrospect at thetime.
(44:09):
Yeah, so of course there willbe a reset in just the market as
it has been going unfortunatelyfor the past two or three years
.
Matt Pillar (44:20):
Yeah, you mentioned your partnership with Forge
Biologics.
I'm curious about what the planmight look like moving forward.
I don't want you to make toostrong forward-looking statement
, but let's fast forward and saythat those tens of thousands of
patients who could benefit fromthis therapy have the
opportunity to benefit from thistherapy.
Let's just use those words.
This is a space where you knowmanufacturing and access and
(44:45):
distribution have presentedchallenges historically.
Access and distribution havepresented challenges
historically.
How do you feel about thatenvironment and its development
between now and that point?
Right Like, do you, do you have, do you have reason to believe
that there's commercial,commercial manufacturing
(45:07):
opportunity in a in a way thatis going to create accessibility
for patients for therapies likethese?
Rick Modi (45:14):
Yeah, really good question.
So what I didn't mentionearlier is one of the other
areas that we spent significantinvestment in the technical side
is also manufacturing Withinour own company.
On site we have a processscience development lab that
goes all the way up to 250liters.
I mentioned to you that one ofthe individuals we brought into
our company, the head ofmanufacturing, came from AVEXIS,
(45:36):
where he's done gene therapymanufacturing to a very good
level of depth.
So the new technology that wehave developed, which is a
proprietary plasmid design toget a little bit into the
technical depth there,proprietary plasmid design, to
get a little bit into thetechnical depth there allows us
to improve our yields by 10times and also improve the
quality of the product.
So we have tech transferredthis to Forge Biologics.
(45:59):
They have replicated theresults.
The results are good even intheir hands, which is again
really good science, and theamount of scale that we are
using at Ford Biologics, similarto ours, is much smaller than
what other companies might haveto use if they did not have this
proprietary plasmid design.
So we are to give you a reallygood example even to go into our
(46:23):
phase one, the first in humantrial, we will use only a 50
liter scale.
Many companies would use a 250or a 500 liter scale.
So that gives us really highconfidence on both the ability
to have the capacity to provideaccess to these patients but
also to manage some of the costof goods sold as well.
(46:44):
When you take into account adisease such as backfeed I did a
cardiomyopathy and you considerthat about a quarter of them
unfortunately require a hearttransplant, the health economic
argument for a disease like thatand the cost on that individual
, that family and overallsociety and the payer, the
budget impact, as they call itis actually really really high.
(47:04):
A heart transplant is millionsof dollars, unfortunately, right
, not to mention the subsequentcost that comes alongside a
heart and immunosuppressantindividual as well.
So again, when we select thesediseases, we're also very
conscious of the societalbenefit and ensuring that we
have both the benefit risk of agene therapy but also a strong
(47:25):
health economic argument tosupport it as well.
Matt Pillar (47:28):
Yeah, yeah, what would be an investor's
trepidation around, like I mean,if you think about it, just you
know, at a baseline level,simply fundamentally we're
taking a technology that hasshown its merit.
It's demonstrated its merit.
There's the potential to takeit out of ultra rare indications
(47:52):
, where you know, as an investoryour benefit, your payback
might be limited into more broadpatient populations, broader
indications, bigger patientpopulations, and you know, to
your point there's a financialequation that's not going to
make it.
Now we won't speculate on whatthe price tag might be, but
(48:16):
certainly competitive to, orbetter than, a multimillion
dollar heart transplant.
So what's the concern?
What would you say is thebiggest concern right now?
Rick Modi (48:26):
I would not say the investors have a concern.
The Receptive is really goodfor the MAG3 dilated
cardiomyopathy program as anexemplary instance of where gene
therapy is a really goodsolution to it, with capsules
such as ours, which gets toliterally 100% of heart cells.
Many investors, unfortunatelyfrom the I'm speaking secondhand
(48:47):
from the dialogues with them-I'm not myself, of course, but
for many investors.
Unfortunately, the last fewyears have not been good, yeah,
especially for the folks thatare in the life science focused
industry, because thegeneralists have benefited from
higher interest rates and otherareas beyond the lifetime sector
.
So for the ones that arefocused on the life science area
, they find more comfort withclinical programs, the programs
(49:12):
that are already in the clinicand where the readout is in the
next, say, six, months.
Matt Pillar (49:17):
Right.
Rick Modi (49:17):
In the case of Afinia , the IND is this year and the
readout is in the early part ofnext year.
So that is part of the excitingpart is that by the time we do
the subsequent financing, it isjust around the corner.
But they're being selective.
Certainly for more clinicalprograms is the main thing.
Sure, I do believe the way thatgene therapy is evolving I think
(49:39):
similar to what biologics wentthrough when I was launching
Remikade decades ago I believethe receptivity and the
perception and the evaluation ofa gene therapy will become
modality agnostic.
It's another potential medicine.
It's another potential patientcommunity.
It's another potential for aninvestor.
(49:59):
The return on investment right.
The fact that it's a genetherapy is perhaps a secondary
point, right.
And so they will look at thescience.
They will look both in terms ofthe human biology for the
disease and then the preclinicalresults that have been
generated by the company forthat particular disease, the
dialogues with the agency, theFDA, and then make a decision on
whether that is something thatfits into their strategic fund
(50:20):
that they are putting money,that they're deploying money for
.
Matt Pillar (50:23):
Yeah, interesting what's been on your agenda here
this week.
Rick Modi (50:30):
Interesting what's been on your agenda here this
week.
So I'd say about a good halfmeetings are business
development meetings just bigcompanies that like our
technology, that also like ourprograms and pipeline as well
and are curious about what we'rewilling to license to them.
And then the other half areprimarily investor meetings.
Again, as I mentioned, it'sbeen four years since we made
the last round.
(50:50):
We've been producing some greatprogress and we should press
solutions for them, so there'ssome inbound interest in would
like to hear more about you whenI use your next fundraise, you
know might make sense to speaknow and then some are, I would
hope such as yourself.
So being able to speak toyourself and just spread the
word out and also share theleadership journey has been also
(51:13):
amazing as well.
Matt Pillar (51:14):
Yeah, it certainly has.
I mean, it's a great story.
You've got a great story.
The work you guys are doing isappreciated.
We'll be paying close attention.
So you've got some pretty biginflection points coming up here
in the next year or so.
So hopefully you'll be willingto come back on the show when
there's some data to share andprogress to share.
Absolutely.
But I've appreciated the time.
(51:35):
I know it's a super busy weekand I'm glad you made some time
for the business, biotechLikewise.
Rick Modi (51:39):
Thanks for having me over and wonderful.
Matt Pillar (51:41):
Yeah, so that's Rick Modi, ceo at Affinia.
I'm Matt Pillar.
This is the Business of BiotechJP Morgan edition.
We will drop again next Monday,I believe, with another JP
Morgan edition, so subscribe.
Wherever you listen to podcasts, make sure you watch the
videocast at Bioprocess Onlineand Life Science Leader under
(52:04):
the Listen and Watch tab, andwe'll see you next week.
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