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On this week's episode, Milan Kalawadia, CEO, North America, Dr. Reddy's Laboratories, and Arun Swaminathan, Ph.D., CEO, Coya Therapeutics discuss their unique partnership to develop COYA 302, a novel dual-mechanism immunotherapy for the treatment of ALS. The partnership pairs Coya's scientific expertise with Dr. Reddy's manufacturing and commercialization capabilities, putting Coya in a financial position to advance development activities and commercialize COYA 302 upon FDA approval, and providing Dr. Reddy's -- a generics, biosimilars, API, and OTC manufacturer -- with an opportunity to pivot into innovative branded products. Kalawadia and Swaminathan discuss their pathways to the CEO role at each company, respectively, how the partnership came together, ongoing FDA engagement, and what COYA 302 could mean for patients with ALS.
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Ben Comer (00:07):
Welcome back to the Business of Biotech.
I'm your host, ben Comer, chiefEditor at Life Science Leader,
and today I'm speaking withMilan Kalawadia, ceo North
America at Dr Reddy'sLaboratories, and Arun
Swaminathan, phd, ceo at KoyaTherapeutics, about their unique
partnership to develop andcommercialize Koya 302, a
(00:30):
dual-mechanism investigationalbiologic combination
immunotherapy.
It's a mouthful for patientswith ALS.
We'll learn about how and whythis collaboration came together
, what it means for each of thetwo companies respectively, and
what's next on the pathwaytoward FDA approval and
commercialization.
Thanks so much for being here,milan and Arun.
Arun Swaminathan, Ph.D. (00:54):
Thank you.
Ben, thanks for having us.
Ben Comer (00:57):
And that's Milan, not Milan.
I'm going to get that rightbefore this conversation is over
.
Milan Kalawadia (01:02):
It's quite all right, quite all right.
Ben Comer (01:05):
Thank you.
I thought that we could startoff with a little bit of
background on both of you, as wedo on the business of biotech.
You've both risen to the verytop of your respective
organizations and I wonder ifyou could just take a couple of
minutes to reflect on your pastexperiences and maybe the
specific circumstances that gotyou to this point.
(01:29):
What previous jobs prepared youfor leading Dr Reddy's and Koya
, respectively, and Millen,maybe we'll start with you, if
that's okay.
Milan Kalawadia (01:39):
Yeah, sure so appreciate the opportunity to be
here with Arun and yourself,ben.
Yeah, sure so appreciate theopportunity to be here with Arun
and yourself, ben, very excitedfor today's conversation.
But to get into the crux of itin your first question, so I'll
start backwards.
So, yes, I'm North America CEOof Dr Reddy's.
I've been with the company forover 19 years now.
(02:00):
But if I go back to thebeginning, I was an undergrad
out of Rutgers University.
I got a degree out of thebusiness school that essentially
set me up for consulting, and Idid consulting for a couple of
years Deloitte Consulting on thesystem side it was during the
era of which dot-coms were thebig buzz was then decided to
(02:22):
join a few startup companieswith the hopes of retiring early
.
Didn't quite work out, ended upgoing back to grad school, got
my MBA from Carnegie Mellon andthen worked at Merck
Pharmaceuticals for a couple ofyears in the finance capacity,
joined Dr Reddy's in 2006 in arole in our finance department,
(02:43):
and then my journey from therehas been tremendous.
Was in North America at a timewhen the company was probably
about 45, 50 employees, about 60million in revenues, and we had
just entered the US market backin 2003.
So a few years before I joined.
So I joined at a time wherethere was tremendous opportunity
and growth.
We entered as a retail genericsbusiness.
(03:05):
I was able to move from financeinto many different roles.
As I stated, I got theopportunity to spend about four
or five years in businessdevelopment where I started to
get exposure to many of ourbusinesses, ultimately moved
into an operating role where Iwas running our marketing group
for our private label OTC andthen started to add
(03:26):
responsibilities related to someof our other commercial
entities.
Our hospital institutionbusiness took over P&L
responsibilities for both theprivate label OTC hospital
institution and then ultimatelythe RxGenerics.
And along the way I had theopportunity to do many other
things as well.
I spent time in running NorthAmerica IR when we were at the
(03:47):
early stages of doing US IR,investor relations, took over
customer service portfolio, andso when you ask the question
about how did my career set meup for the role I'm in, I would
say predominantly twofold.
One early stage of my career wasthe mindset around being
entrepreneurial, strategic,trying to find opportunities,
(04:10):
doing what it takes to win.
The Dr Reddy's experiencehelped groom me to get through
different roles andresponsibilities that ultimately
set the stage for me to havethis opportunity, which I've
been in for a little over a yearnow, which is responsible for
North America, a business that'snow 1.7 billion plus in
revenues, about 300-ishemployees within North America,
(04:33):
which includes US and Canada,and looking forward to driving
future growth in a couple of ourother additional areas beyond
the base businesses of privatelabel OTC, hospital institution
and retail generics.
And those growth businesses areour self-care wellness division
and our biosimilars division,and we'll get into more details,
I'm sure, through thisdiscussion around how the
(04:56):
partnership with COIA is areally good intersection of
where Dr Reddy is headed and howwe got to that partnership.
But that's a bit about mybackground and appreciate you
giving me that opportunity.
Ben Comer (05:08):
Yeah, that's perfect, Milan.
Thank you so much for that, andwe'll definitely get into the
partnership.
And also, you know, I have aquestion or two, maybe just
about the evolving biosimilarslandscape too, that I might try
to sneak in.
But, Arun, let's talk aboutyour background.
And oh, last thing, Milan, thisis your first CEO role, is that
right?
That's correct, okay, all right, excellent, all right, Arun,
(05:31):
take it away.
Arun Swaminathan, Ph.D. (05:33):
Yeah, no, thank you, Ben.
It's a pleasure to be here onyour show with Milan and you
Appreciate the opportunity.
I'm currently the CEO of CoyaTherapeutics and what excites me
and I think that has defined mycareer is the intersection of
science and business, and you'llsee that, both serendipitous
(05:53):
and through my own plannedapproaches, that's exactly what
I've gravitated towardsthroughout my career.
Going backwards, I'm apharmacist by training and I
also got a PhD from theUniversity of Pittsburgh in
transplant immunology.
So that's kind of my academicbackground.
(06:13):
That led me to places likeBristol-Myers Squibb and I say
this quite a bit.
I grew up at Bristol-MyersSquibb and what I mean by that
is Bristol-Myers Squibb, becauseof the size of the company
allowed me to get experiencesacross a spectrum of things.
I started by designing andrunning clinical trials, because
(06:35):
I was a clinical pharmacologistby training.
So I got to understand how thatworks.
How do you design them, how doyou get them going, what does it
take to get IND approvals andFDA approvals, et cetera.
So I was directly involved intaking one product all the way
from IND to an NDA filing fromthe scientific perspective.
(06:56):
But that also got me exposed tothe commercial side of the
business side of the business,and then I did multiple roles in
commercial strategy, marketing,brand lead roles as well as
business development roles atBMS.
All of that kind of gave methat foundation, a solid
(07:22):
foundation to be able to do whatI've been doing the last 10
years, which is really makinggood science come to life, and
that's kind of what I'mpassionate about Last 10 years.
Briefly, I started I got theentrepreneurial bug, co-founded
a biotech company about 10 to 11years ago, so that was the
start of my small companyjourney.
Since then I've been in theC-suite of small public biotech
(07:47):
companies, koya being my fourthcompany that I'm at in the last
10 years.
I gravitated to Koya because ofexactly what I was telling you
before, ben, which is that itwas a perfect intersection of
science and potential and marketpotential for me.
I could see the value of thescientific approach.
(08:08):
I could see the elegance andsimplicity of our approach,
which hopefully we'll talk about, and that's what got me excited
.
I joined COIA two and a halfyears ago as a chief business
officer and had theresponsibility to successfully
complete the businessdevelopment deal and bring Dr
(08:28):
Reddy's on as our partner, whichwe are extremely grateful for,
because it's been such avalue-creating partnership for
us.
And then I assumed the role ofthe CEO about I want to say
about nine months ago.
Ben Comer (08:42):
All right, all right, yeah.
So leading small publicbiotechs is not a job for the
faint of heart, as you well know, arun.
You know what I'm hearing incommon from both of you is that
you've both worked across anumber of different functions in
life sciences companies, whichI suspect has set you up quite
(09:03):
well for the CEO role, and howmultifaceted it is, and we'll
maybe talk some more about that.
But I want to go back to you,mellon, for a moment here.
Dr Reddy's Laboratories isknown, I think, primarily for
manufacturing generic drugs,biosimilars, api,
(09:24):
over-the-counter retail products, as you mentioned.
But today we're talking aboutan innovative combination
product that Koya is developing,that Dr Reddy's will
commercialize.
And before we get into Koya 302, can you kind of talk a little
bit, millen, about what thisdeal means for Dr Reddy's and
(09:47):
kind of the thinking behind it?
Milan Kalawadia (09:50):
Sure, ben, I appreciate the opportunity to
address this.
For Dr Reddy's, yes, we are anAPI company moved in to finish
formulations and generics In theearly 2000s we got into
biosimilars and first starteddeveloping and selling
biosimilars into the emergingmarkets.
But there's always been a highlevel of interest and effort
(10:14):
that has gone behind innovativescience and innovative medicine
within the company.
And if I take it back to ourfounder, Dr.
Anji Reddy, he always had thedesire and the passion to launch
an innovative asset out of DrReddy's, and so that transpired
(10:34):
over the years.
There were a few efforts thatwe had gone down the path of,
not as successfully as we wouldhave liked.
To date, however, there's stilla high level of interest and
focus on innovative science, andso when I think about the
transaction or the partnership Ishould say with COYA, it was a
(10:55):
nice intersection of some of ourcapabilities with our desires
to get into innovative science,but then also tying it back to
Dr Reddy's and our purpose andour mission.
So one of the areas that DrReddy's is really focused on is
bringing solutions and productsthat can help meet unmet medical
(11:16):
needs, and the segment thatCOYA 302 actually helps address
is ALS.
It's an area that, as we know,has had very few products that
have come to market that areable to address the disease
state, and so it was a veryexciting opportunity to discuss
(11:39):
with Arun and team, and as westarted to dig into it, started
to align more and more with howthis is an asset that would be
one that Dr Reddy's couldactually partner with Coya and
help make a huge success.
And so when I think about yourquestion and how this is key for
Dr Reddy's, I think it's thenext evolution of our journey.
(12:03):
We are moving from, orcontinuing to be, a generics
player.
Moving into biosimilars butnovel products and new
development efforts is the nextwave, and Coya 302 fits in
nicely with that.
Ben Comer (12:19):
Yeah, I definitely want to pick up on this new kind
of adventure in innovativemedicines with Koya 302.
I have a quick question though,about the kind of evolution of
the biosimilar space which is.
You know.
I've seen a number of differentand this is more of a
commercial question, I won'tspend a lot of time on it, but
(12:40):
I've seen different approacheswhere a company and this is
maybe particular to the USmarket, but companies going in
with a biosimilar that is pricedat, you know, not much of a
discount off of the brand name,and then biosimilars coming in
at a pretty steep discount tothe brand name.
And I think the thinking thereis, you know some of the PBMs
(13:02):
prefer the higher pricebiosimilar, which they will.
Then you know the companieswill then discount and you know
the PBMs can make money off ofthat versus, I would assume, in
emerging markets the kind oflower price and maybe in parts
of the US or certain healthsystems or insurance plans, the
lower price is more effective.
I'm just curious, millen, kindof top level, what you're
(13:24):
thinking is in terms of how thatis evolving, the landscape for
biosimilars pricing, and ifthere's one strategy that you're
finding leads to better patientaccess to biosimilars.
Milan Kalawadia (13:38):
So specific for the US market.
Ben Comer (13:40):
Yeah, sure.
Yeah because I think with thehigh-low, you know playing with
the price.
I think that's probablyspecific to the US.
Sure, yeah, because I thinkwith the high-low, you know
playing with the price.
I think that's probablyspecific to the US.
Milan Kalawadia (13:48):
Yeah, yeah, so probably be a little bit broad
in the response here.
But Ultimately with any productlaunch it's market dynamic
dependent, and so in thebiosimilar space there are two
distinct segments.
There's the medical benefit andthe pharmacy benefit side.
Those two segments operate verydifferently and so pricing is
(14:11):
dictated by the segment withinwhich the products align, and
then it's also dependent on thenumber of competitors that come
to market on a given product ata given point in time.
So strategies evolve.
I don't think there's onecookie cutter response to your
question in terms of it's goingdown a particular pathway.
It's product to product,specific and unique to the
(14:32):
channel within which the productis placed.
Ben Comer (14:35):
Okay, all right, thanks for that, Arun.
Let's get back to COIA-302.
But first I wonder if you couldprovide a kind of high-level
explanation of COIA Therapeuticsdevelopment, work in multimodal
Treg therapies and maybe thekinds of diseases and
therapeutic areas that COIA istargeting.
Arun Swaminathan, Ph.D. (14:58):
Yeah, certainly Ben.
So our focus at Coya, ourvision, is to make devastating
neurodegenerative diseaseslivable diseases.
Today, most of these diseasesare a rapidly declining quality
of life issue for patients, andwith many of these diseases the
(15:20):
lifespans are significantlyshortened as well.
With ALS, for example, theaverage ALS patient lives three
to five years after diagnosisand in that three to five years
they are rapidly declining intheir physical ability.
So that is what we want totransform.
We want to bring solutions tothe market that hopefully allow
(15:42):
these patients to lead a normallife.
So our focus isneurodegenerative diseases and
what we fundamentally focus onis neuroinflammation.
What we know, ben, is that whenneuroinflammation is high, it
is directly correlated withprogression of many
(16:03):
neurodegenerative diseases, likeALS, like FTD, alzheimer's,
parkinson's, right, and so webelieve that slowing down or
stopping the neuroinflammationand its source is the way to
stop the progression of thesediseases.
To be clear, we're not talkinga cure yet.
We are talking about stoppingthe progression of these
(16:25):
diseases, which, by the way,nothing there currently does
that and not even remotely closeto stopping the progression.
So we would love to see thathappen.
And the way we addressneuroinflammation is by
addressing the regulatory Tcells, as the name implies, they
are immune cells that regulatesomething.
(16:46):
They are kind of the brakes ofthe immune system, right?
They basically say to theimmune system don't go at 100
miles an hour, you should begoing at 20.
And when that happens, there'sa good the good cells are not
being attacked.
What happens inneurodegenerative diseases is
these Tregs, which are thebrakes, are not functional and
(17:09):
then the T cells and the rest ofthe immune system starts
attacking healthy neurons ornerve cells.
When this happens, basicallyour internal spark plugs are
misfiring, right, which is whatthe neurons and nerve cells are,
and this leads to theprogression of neurodegenerative
diseases.
So we, our whole focus is onmaking these Tregs functional
(17:35):
and keeping them functional in adurable manner, and that's
exactly what we do with COYA-302.
COYA 302 is a proprietarycombination of a low-dose
interleukin-2.
On its own, interleukin-2 willincrease.
Low-dose will increase thenumber and function of Tregs,
(17:55):
which is what we want.
But the CTLA-4 is a criticalcombination, because what we do
with CTLA-4 is keep theinflammation driven by the
myeloid cell, by the macrophages, also low.
And that's because the CTLA-4acts on a different mechanism,
by acting on CD8086.
(18:17):
Because the CTLA-4 acts on adifferent mechanism by acting on
CD8086.
So we're acting on two aspectsof the immune system that then
keep that balance.
One allows for the Tregsnumbers to go up and the
functions to go up and the other, in combination, allows for it
to stay anti-inflammatory, themacroenvironment, thereby
keeping the Tregs functional forlong, which means it should
(18:39):
translate into durable clinicalefficacy.
And that's what we have seen insmall investigator-initiated
trial that was conducted, thatwe are seeing that we're able to
keep ALS patients fromdeclining.
At six months a small IIT studyand at one year there was very
minimal decline when normallythese patients would have
(19:00):
declined pretty dramatically inthat same time period.
Ben Comer (19:04):
Right, and a component of COYA-302 is
abatacept, a drug that you knowis, I believe, Coya in-licensed
from Dr Reddy's.
Initially it's a biosimilar ofBMS's Orencia.
It may also be in developmentat Dr Reddy's as a biosimilar.
(19:27):
I'll check in with Milan onthat.
But I want to hear how thispartnership came together.
It sounds well.
Well, I'm assuming that itstarted with the in-licensing of
abatacept but, um, Arun, maybeI'll stay with you for a minute
and then I'll get um and thenI'll uh, I'll ask um uh melon to
(19:48):
chime in.
But um, how did this cometogether?
And you know how?
Who, who had this idea that Dr.
Reddy's would ultimatelycommercialize this product.
But let's hear the Coya storyfirst.
Arun Swaminathan, Ph.D. (20:01):
I'll give you the Coya side of it.
I think Milan said it earlier.
The intersections that the twocompanies have was a natural
synergy, One you just pointedout abatacept is one of the
components of COYA-302, and DrReddy's is manufacturing
(20:22):
abatacept, so that's just numberone, a very natural synergy
right there to be in the nextwave into more innovative
therapies.
We were aware of that as well.
Dr Ellison has publicly statedthat.
And the synergy between the twocompanies in terms of our
(20:49):
ability to bring to the tabledifferent skill sets, different
capabilities, where we felt thatone plus one is going to be
better than two.
And I think we are alreadyseeing that in the one year of
our partnership.
And that's what brought us tothe table together.
And so it was kind of a naturalprogressive conversation that
happened between the leadershipof Coya and leadership of Dr
(21:12):
Reddy's.
It kind of made intuitive senseto both sides and it was very
clear that both sides are goingto create value together and,
more importantly, together wecan bring this therapy hopefully
faster to patients, and that'sreally what drove all of this.
And there's a common missionthat we have that we want to
bring address unmet needs forpatients.
(21:34):
I'll let Milan give the DRLside of the story.
Ben Comer (21:39):
Yeah, and Milan, before I turn it over to you, I
just had a quick question aboutOrencia, arun, kind of from a
scientific level.
Were you familiar with Orencia?
You know kind of as you werethinking about, you know the
development of 302, was thatsomething that you had kind of
hands-on knowledge of?
(21:59):
Was there overlap of that drugwith you at BMS?
Arun Swaminathan, Ph.D. (22:03):
Yes, Ben.
I was on the launch team ofOrencia way back in 2005 as a
junior marketing person onOrencia soon after the launch, I
should say and then I was alsothe worldwide brand head and
director for Orencia.
So I'm extremely familiar withabatacept, with Orencia.
(22:27):
Of course, my focus was onmarketing Orencia for patients
with rheumatoid arthritis, whichis the primary indication
Orencia was approved for.
I was also involved in Orenciawhen it transitioned from an IV
to sub-Q presentation as well,so I have deep knowledge of
(22:47):
Orencia from my Bristol-MyersSquibb days.
Ben Comer (22:51):
Okay, that makes a lot of sense.
Milan, what made Dr Reddy'sdecide we're going to
commercialize this quite noveldrug mechanism, an innovative
product?
It seems like something of adeparture.
But yeah, how did that?
What's the Dr Reddy story?
Milan Kalawadia (23:11):
Sure, sure, yeah, absolutely does seem like
a departure from where we are attoday, but not where we're
headed.
But before I get to that, youknow what started as a
discussion between Koya and DrReddy's around what could have
been a simple supply deal toprovide a Badasept evolved as we
(23:33):
started to engage in dialogueand conversation.
As we started to engage indialogue and conversation, arun
and team obviously shared avision, shared the insights on
the project and the work thatthey were doing with our
business development team, andthere seemed to be a good
opportunity here, which thenrequired deeper diligence, a
little bit more understanding ofthe journey that Koya and team
had been on the foundationalwork that they've done to date
(23:55):
to actually start the program,to then now get to the point
where, uh, that abitasa was nowrequired as part of the broader
landscape, and so it was reallyexciting for us was a project
that we were working on, waspotentially going to have an
opportunity to serve a biggerpurpose, and so so, connecting
(24:15):
with Arun and Koya and findingan opportunity to take our
Abitacid program, which we werein the process of taking forward
for the US market as abiosimilar R&D efforts were
underway, commercialgo-to-market strategies were
being devised, then had theopportunity to now serve yet
(24:37):
another purpose and also meet anunmet medical need, like we
talked about earlier, which isto treat ALS patients.
So when we go back to theintersection of the deep science
that Koya worked on, to thedevelopment work that we were
doing for a biosimilar asset, tothen the commercial aspirations
and Dr Reddy's desire to getinto innovative assets, it was
(25:01):
great timing for one, but thenalso a great opportunity.
And so, while it may seem as adeparture Ben, we're already
going down the path of buildingcapabilities for our biosimilars
.
We're in the process.
We were at the early stageswhen we first signed the deal,
but where we sit today, we havea team in place that's working
on the infrastructure build-out,that's preparing for a
(25:24):
biosimilars launch, that'sworking towards commercializing
an asset in a branded fashion.
Now biosimilars, different thangenerics, are going to require
market access teams.
They're going to require afield force.
We have a in-house marketingdepartment, so we're building
out capabilities.
That also leads us down thepath of being a good strategic
(25:47):
partner for Koya and to enterinto this relationship to
commercialize the asset, becausetiming will be quite optimal in
the sense that we will havelaunched.
Our biosimilars are notgenerics.
You do need a market accessteam.
Ben Comer (26:15):
You may need even a sales force to go out and talk
to physicians.
You may need a kind of keyaccounts manager for payers.
It's a very differentexperience, right than marketing
and selling a small moleculegeneric drug.
Okay, that makes a lot of sense.
As far as Arun, next, I havekind of a funding question for
(26:40):
you and I remember you know theIce Bucket Challenge and ALS
probably one of like the biggest, most successful fundraisers
for any disease state.
But you know, here we are stilltoday without a really
effective treatment for ALS.
It's no surprise to anyone thatit's a very difficult
(27:01):
environment in the publicmarkets right now.
It's not easy to fundraisereally for anyone in early
stages of development.
What kind of I guess, strategicrationale would you give for
licensing COIA-302 to Dr Reddy'sfor commercialization and does
(27:21):
that actually help you progressthe asset?
Arun Swaminathan, Ph.D. (27:24):
First, 100%.
I think our partnership enablesto advance the asset more
efficiently and also in a morerigorous manner, because we now
have the power of Dr Reddy'sthought process and expertise as
well.
The power of two brains, twocorporate brains is better than
(27:44):
one any day and we fullyleverage that.
And I think it's a no-braineranswer for me that, yes, it
absolutely creates value.
As far as the capital markets,you're right, Ben.
I mean it's a tough market forbiotechs.
It has been a tough market forbiotechs the last few years and
(28:06):
that was part of our rationalealso to enter into a partnership
with Dr Reddy's, with ALS.
What we have been able to dothrough that partnership is a
couple of things.
One is it just made more senseto put this product in the hands
of somebody like Dr Reddy's andMillen's team that has the
(28:26):
sales force, that has thecommercial experience, that has
PVM teams and managed care teamsthat can address a lot of the
things that COIA doesn't havethe infrastructure to do.
So it just made a lot of sensethat we don't do that ourselves.
I'm a big believer thatstrategic deals are about
(28:47):
leveraging do what you're goodat and let somebody else do what
they're good at, and I thinkthat's what we're doing here.
And then the second thing from acapital market is that I mean,
I don't know if the marketagrees with me I do think we
have removed an overhang that alot of small biotechs have.
When they get approved, whenthe BLA is good, immediately the
(29:11):
market goes okay.
Now Koya is going to have tospend millions and millions and
millions marketing this, but wehave taken that off of the first
indication, ALS, because wehave a strong financial partner
in Dr Reddy's who will beresponsible for commercializing.
So there is that benefit.
Definitely that wasn't the mainreason we did this partnership,
(29:34):
but I think it is a byproductof it for sure, and that has
helped us with the capitalmarkets.
It has helped us stay cashefficient with the support of Dr
Reddy's, and we are, for asmall biotech company, in a
relatively good cash positionwhen you compare us to a lot of
our peers, and I think that haspartly been possible because of
(29:56):
this strategic partnership.
Ben Comer (29:58):
Yeah, and then on manufacturing, you know
obviously Dr Reddy's is morethan capable of scaling up
Abatacept manufacturing for latestage clinical trials.
What about the other componentof 302?
Are you in the process now ofscaling up that manufacturing,
and is that actually done by aseparate CDMO or by COIA
(30:23):
internally?
And how does that, I guess,work, just thinking about
needing to create more of COIA302 as the drug progresses into
the final stages of clinicaltrials?
Arun Swaminathan, Ph.D. (30:36):
So the clinical supply we have lined up
and it is from a CDMO that isoutside of Dr Reddy's.
I'm going to hold fromspeculating or sharing with you
because we haven't publicly doneso on our plans for
commercialization, but it goeswithout saying we work very
closely with Dr Reddy's on howand when we would do that
(30:59):
manufacturing of the low-doseIL-2 as well, but the CTLA-4
obviously already ismanufactured by Dr Reddy's.
And you brought up a very goodpoint, ben.
Among lots of the synergieswith Dr Reddy's is also their
expertise in manufacturing.
It's not the core strength ofCOIA.
We are not a manufacturingcompany.
(31:21):
We are advancing the science ofTregs, understanding
neuroscience, understandingclinical trial design company.
So the two things come welltogether when you think about
our two companies and I thinkyeah, I think that's what I can
appropriately say at this point,obviously at the right time,
what Dr Rennes and us will sharein more detail how we are
(31:44):
preparing for commercialization.
Ben Comer (31:47):
Great and Milan, you've talked about how COYA 302
, commercializing COYA 302, iscomplementary to some of your
other lines of business, inparticular biosimilars and the
capabilities that you're alreadyin the process of building
there of its innovative drugfrom you in the very beginning.
(32:15):
But do you see this as ajumping off point for
potentially futurecommercialization deals with
other innovative companies andother innovative brands?
Are you making those plansalready, or is that something
that you're going to look at ina kind of opportunistic way or
no?
Arun Swaminathan, Ph.D. (32:39):
I think the simple answer is yes, it's
an opportunity.
As we think about evolvingbusiness models.
COYA 302 is the focus, however,from a space to play with
innovative assets.
As I stated earlier, is an areathat has been of interest to us
, and so we are in early stagesof going beyond just a single
(32:59):
asset, type of environment andlooking strategically on how
best to move forward andcontinue to build and evolve in
novel products, and so I'llrefrain from maybe sharing much
more detail, but it definitelycreates an opportunity for us to
now continue to evolve thisside of the business Right.
Ben Comer (33:19):
Ok, so you don't have any kind of set product goal.
You know we're going tocommercialize X number of
innovative drugs in 2026 or 27or 28.
Milan Kalawadia (33:29):
At this point, yeah, no, we we from sharing
forward-looking statements suchas that as a company, and we
have not stated specific targetson how many products we'd be
looking to launch by certainperiods of time, but simply
stated this is an area of thebusiness that we want to
continue to focus on and grow.
Ben Comer (33:52):
Excellent.
We've talked a little bit aboutCoya 302 and how it's different
, Arun.
It's a combination of twoseparate active components
coming together.
The lead indication is for ALS.
Is there anything else I guessyou would share about other
(34:12):
indications or future plans for302?
Yeah, let me just leave itthere.
What else is happening in termsof development?
Is it in parallel?
Will you go for this kind offirst approval in ALS before
looking at advancing otherclinical programs and other
indications?
(34:32):
Sorry, I put a lot of questionsin there at one time for you,
Arun.
Arun Swaminathan, Ph.D. (34:37):
No, that's perfectly fine, ben.
Yes, our priority is ALS.
So I think we want to first getALS advanced, which hopefully,
once we receive the green lightfrom the FDA, which we
anticipate in the next 7 to 10days, we'll hopefully be able to
(34:57):
initiate that potentiallypivotal phase 2b study in
patients with ALS.
So that is our number onepriority for 2025.
However, as I previouslymentioned to you, our mechanism
will absolutely work infrontotemporal dementia and
other diseases as well.
So our second indication ofpriority, if I can call it in
(35:22):
order, is frontotemporaldementia.
We fully intend to submit anIND to the FDA on FTD towards
the end of this year, once ourALS trial is up and running.
That's our current plan and wehave publicly disclosed that and
then, if all goes well, we willinitiate a small phase 2B study
(35:44):
that will have been funded,partly at least, by the
Alzheimer's Drug DiscoveryFoundation sometime next year,
in the first half of next year.
That's kind of our two areas offocus On Alzheimer's and
Parkinson's disease.
Right now we are focused onalso a different acid, coya-303,
(36:06):
which is a combination withGLP-1 agonists, the popular
weight loss drugs that have thepotential in diseases like
Alzheimer's disease.
Of course, as you may be aware,there's going to be some
significantly big readoutscoming out of no one, nor this
semaglutide towards the end ofthis year on the two big trials,
(36:27):
evok and EVOK+, that they'reconducting in patients with mild
Alzheimer's disease.
So I do think that opens up alot of value creating potential
for COIA in the Alzheimer'sdisease space.
But our immediate priority forCOIA-302 is ALS.
Number one hopefully get theFDA green light, get that trial
(36:49):
started, followed by frontaltemporal dementia.
We have showninvestigator-initiated trial
data in a very small group ofFTD patients that we do
something similar to what we'veseen in ALS, which is we stop
the cognitive decline in thesepatients.
In the case of FTD it'scognitive function as opposed to
(37:09):
physical function more, andwe've shown that we're stopping
it.
And, more importantly, we'reseeing that the science plays
out.
We see Treg numbers andfunction improve with this
combination IL-2 plus CTLA-4,and staying durable.
And then that translates to thebiomarkers moving the right way
and then that is translated bythe small study to the
(37:33):
stabilization of the disease.
And that's what we like to seeas a scientific company is that
everything lines up.
That increases our confidence,one in the outcome, the
probability of technical andregulatory success in ALS as
well, and in other diseases aswe move forward.
Ben Comer (37:52):
On the combination with the GLP-1, is that one?
Are you kind of lining up thatclinical program with being able
to market maybe semaglutidespecifically?
Are you looking at other youknow active GLP-1 ingredients, I
guess how are you thinkingabout that?
You know the potential patentexpiry of semaglutide and then
(38:13):
how you move that in if that isindeed you know the molecule
that you're targeting.
Arun Swaminathan, Ph.D. (38:18):
So we're keeping our options open
on the GLP-1 pen.
But what we have generated todate is data with semaglutide
and with exenatide and we'veshown that semaglutide plus
COYA-301, which is herproprietary low-dose IL-2, is
synergistic in neuroinflammatorymarkers.
(38:39):
This is all preclinical,non-clinical work, so obviously
we'll have to show anddemonstrate this at some point
in the clinic.
But you know we're not and ofcourse we do have IP around it.
So we have the patent rights tothe combination of flow dosing
from looking to with any GLP-1agonist, not just 7-WP.
Ben Comer (39:00):
Got it, thank you.
Thank you for that.
Milan, I want to come back toyou on the commercial launch us
a lot of information about howyou're approaching this,
building out sales teams thatwill have kind of double duty,
being able to sell biosimilarsas well as Coya 302 once that is
(39:21):
approved.
But can you talk about how youbuild up those capabilities and
kind of where you're focused on?
I mean, are there any key newhires that you're making?
Are you thinking aboutSalesforce size?
Are you thinking about, youknow, specific regions or even
ex-US opportunities at thispoint?
Milan Kalawadia (39:41):
Yeah, no great question All of it.
So we've been on a journey inthe US and we have been
fortunate to find some greattalent in the market that has
joined to help us evolve ourcommercial infrastructure,
(40:02):
internal marketing capabilitiesto pricing analytics, and then
also focusing on market access,and I'll call it field force
design and ultimate accountmanagement.
(40:22):
And so we are being verymethodical in our approach.
We're looking for, one, theright talent, but two, the right
approach to actually go tomarket and commercialize.
We've had discussions around dowe build the in-house
Salesforce?
Do we go contract Salesforce?
Are there other partnershipmodels that we can evolve?
And so those discussions are ata very mature state At the
(40:47):
moment.
When it comes to hiring, thereare probably a few more key
talents that we need to bringinternally, but we have decided
that, from a Salesforce designperspective, we are staffing for
the US.
We have done our field forsizing, but we're going to do it
through a third-party model atthe time.
At this time, at a future pointin time, as the business
(41:11):
evolves and grows, chances arewe would internalize, but at the
moment it's going to be athird-party approach.
And so we're constantly lookingat the business model, the
go-to-market strategy, evolvingit to make sure that we're
nimble, but setting ourselves upfor success, and so I'm very
confident at the approach thatthe team has been undertaking,
(41:32):
and we're very excited for ourfirst biosimilar launch, which
is should, if all goes well, benext summer, followed by a
potential abatacept launch inthe year after, and so a lot of
work is underway, but we will beready for those launches, as
well as the future launch ofCOYA 302.
Ben Comer (41:53):
Okay, and you just answered a question that I had
that I had kind of forgottenabout, which is you are also
developing, you know, inparallel, a kind of a biosimilar
, or, you know, pushingabatacept forward as a potential
biosimilar to Orencia, at thesame time as Coya is developing
302.
Arun Swaminathan, Ph.D. (42:14):
That's accurate, that is correct, and
there is a broader pipelinebehind the biosimilars business
as well, but abatacin becomesthe first major molecule that
will launch under that division.
Ben Comer (42:27):
Great, excellent, Arun, I want to come back to you
for a question on IP.
Obviously, it's a criticallyimportant function of value for
a biotech.
You've got a unique product onyour hands.
What can you tell me about Coya302's intellectual property
(42:48):
holdings, and maybe just give mea sense of what those are?
Arun Swaminathan, Ph.D. (42:53):
Yes, Ben, COYA 302 actually has a
very strong IP portfolio.
I like to call it like an onion.
We have a complex series of IPthat protects COYA 302 in a very
robust manner, with the averagelife of the intellectual
property going well into the2040s.
So we are well protected.
(43:15):
And I'll explain to you why.
There's really three keyreasons.
One we have a proprietarylow-dose interleukin-2.
The patent was granted and wepublicly disclosed that in June.
So we have the aqueous low-doseinterleukin-2, and the methods
around it is part of ourintellectual property rights.
(43:36):
What that allows you to do isit allows you to administer
low-dose IL-2 as a subcutaneousadministration.
The currently available IL-2,which is used in the oncology
indications at a much, much,much higher dose, is a
lyophilized, freeze-driedpresentation that needs to be
then reconstituted and it'sadministered intravenously.
(43:59):
So we have enabled, through ourintellectual property, the
administration of IL-2 in aself-administered or, in the
case of ALS patients, likelycaregiver administered, but it
can be done at a home setting.
So that's IP number one.
We also have intellectualproperty around the combination
of any interleukin-2, includingmutines, spegulated long actings
(44:24):
, with any CTLA-4 inhibitor.
So that gives us a powerfulprotection around COYA 302.
And to wrap it around.
We have some additionalbiomarker patents on ALS that
also give additional protectionfor COIA-302.
And so there's very strong IPand, assuming that one gets an
(44:49):
Orphan Disease designation,these diseases definitely
qualify Outside of the IP.
The FDA tends to grant aseven-year commercial
exclusivity for those types ofproducts as well, so we feel
pretty good about the ability toprotect COIA-302 commercial.
Ben Comer (45:09):
Got it.
And just to clarify, COYA 302will ultimately be a sub-Q
administration that can be donelike, say, by an ALS patient,
his or herself or a familymember.
It doesn't have to be ahealthcare practitioner.
That's giving it.
That's an important, I think animportant attribute for the
(45:31):
product potentially.
Arun Swaminathan, Ph.D. (45:32):
Exactly , Ben, and that is key to
understand is that thepresentations and that's how we
are designing the clinical trial.
The clinical trial will be donewhere, after the first
administration or so, thepatients are trained or their
caregivers are trained and theyadminister it at home.
And these injections are nodifferent than the current
Orencia injections or GLP-1injections.
(45:56):
They're easy.
It's not like complicated,they're not slow infusions or
slow sub-Q, it's a single shotadministration which makes it
very easier for the patient tonot have to go to the clinic or
that kind of setting to gettheir dosing done.
Ben Comer (46:17):
Got it.
And then, speaking of clinicaltrial design, could you describe
what kind of engagement Arunthat you and Koya have had with
the FDA?
Have they, you know, have theybeen instructive and, you know,
offering guidance, or, you know,have you had other
conversations with them aboutTregs?
(46:40):
Where does that kind ofrelationship stand, if I can put
it that way?
Arun Swaminathan, Ph.D. (46:44):
I mean we have had multiple
interactions with the FDA andwhat I can say is the FDA is
extremely collaborative.
I think the FDA has the samemission we all have, which is to
bring better options topatients.
Through the last year we havehad discussions with them on the
data needed for them to say,okay, you can go ahead with your
(47:05):
phase 2B trial.
We've had good alignment withthem.
We have submitted that data.
We anticipate a response fromthem in the upcoming week, a
week or so.
So it's been a pretty goodengagement and, from our
experience, as part of that,obviously the clinical trial
protocol is part of that.
(47:26):
So we do get feedback from theFDA on our design.
So by the time we get all thisstarted, we are aligned with the
FDA and we'll have confirmationthat we're aligned, hopefully
in a couple of weeks with theFDA.
So it's been a verycollaborative process and we
have not seen anything differentin our interactions with the
(47:48):
FDA.
And I'll add that ourregulatory submissions are also
strengthened through ourpartnership with DRL, because we
do leverage their regulatoryexperts as we prepare these
documents that we submit to theFDA and other agencies as well.
Ben Comer (48:05):
Oh, ok, I'm glad you mentioned that.
That's an important resource,you know, I would imagine, for
any small biotech company tohave access to regulatory
experts.
We are running short on time,but I want to get just a final
thought from both of you aboutkey priorities.
You know for the rest of thisyear, and maybe Arun we'll keep
(48:26):
it with you and then we'll endwith Milan, but you know what's
next for COYA-302?
You're going to hear somethingback from the FDA in a couple of
weeks, but you know what's thekey next step.
What's your top priority forthe rest of 2025?
Arun Swaminathan, Ph.D. (48:42):
Well advancing.
The clinical trial in ALS ispriority number one.
Obviously, that's contingent ongetting that green light from
the FDA, but that is our numberone priority for 2025, getting
that trial started in 2025.
Ben Comer (48:57):
And that'll be the Phase 3 trial.
Arun Swaminathan, Ph.D. (48:59):
It'll be a phase two B, okay, in 2025.
And that'll be the phase threetrial.
It'll be a phase two B, butwith ALS, the FDA has precedence
of approving products with justone trial because of the high
unmet need.
Of course, that'll be subjectto data and we'll have to have a
discussion with the regulatorybodies at the right time about
it.
But, yeah, there is precedencefor it.
So that is our number onepriority Get the ALS clinical
(49:20):
trial off the ground.
Number two is file the IND forfrontotemporal dementia after
that and then get ready to starta small trial in FTD in 2026.
And then, in parallel, we'lladvance our COIA-303 from a
preclinical perspective.
We have an ongoing animal studythat will hopefully further
(49:44):
strengthen our hypothesis aroundthe synergy and we should be
able to disclose that publiclywe hope in the second half of
2025 as well.
So these are some of the things, and we'll continue to generate
more data around biomarkers andprediction in these ALS and
other diseases as well in thesecond half of 2025.
(50:04):
But our number one priority isgetting the ALS clinical trial
started.
Ben Comer (50:10):
Got it and Milan.
What are your top priorities atDr Reddy's, for the rest of
2025?
Milan Kalawadia (50:17):
Yeah, so specific to the partnership we
have with COYA and 302,continuing to help progress the
outcome right.
So waiting for FDA feedback, butpartnering from a regulatory
standpoint as the productcontinues to evolve, engaging in
manufacturing-relateddiscussions to continue to or
(50:38):
continuing to ensure that we areready for success.
So that becomes, and continuesto be, a priority as it relates
to the partnership, the greatpartnership we have with Coya,
as I think, beyond thisconversation and the rest of the
business, a few differentthings that are priorities we
need to continue to drive ourbase business, drive growth out
(50:59):
of the base business, which isour generic portfolio here in
the US, putting a lot of timeand energy behind our growth
initiatives, which is the selfcare wellness space, as well as
the biosimilars which we spentsome time talking about today.
And then another criticalcomponent of the overall
priority list is we have aportfolio of GLP-1s.
(51:19):
We're actually in a position tolaunch our first GLP-1 in
Canada, which is semaglutide,and the preparations to ensure
that we are ready for day one.
Launch of that product inCanada is probably the top
priority at this point.
Ben Comer (51:35):
So, Arun, you've already got a supplier for your
semaglutide product, then Well,yeah, I mean, obviously we'll
have those conversations.
Milan Kalawadia (51:46):
I can't share any details at this point.
Ben Comer (51:49):
Thank you so much, both of you, for being on the
show.
We've been speaking with MilanKalawadia, CEO of North America
at Dr Reddy's Laboratories, andArun Swaminathan, Ph.
D.
, CEO at Coya Therapeutics.
I'm Ben Comer and you've justlistened to the Business of
Biotech.
Find us and subscribe anywhereyou listen to podcasts and be
(52:12):
sure to check out new weeklyvideo casts of these
conversations every Monday underthe Business of Biotech tab at
lifescienceleader.
com.
We'll see you next week andthanks, as always, for listening
.
Welcome back to the Business of Biotech.
I'm your host, ben Comer, chiefEditor at Life Science Leader,
and today I'm speaking withMilan Kalawadia, ceo North
America at Dr Reddy'sLaboratories, and Arun
Swaminathan, phd, ceo at KoyaTherapeutics, about their unique
partnership to develop andcommercialize Koya 302, a
(00:30):
dual-mechanism investigationalbiologic combination
immunotherapy.
It's a mouthful for patientswith ALS.
We'll learn about how and whythis collaboration came together
, what it means for each of thetwo companies respectively, and
what's next on the pathwaytoward FDA approval and
commercialization.
Thanks so much for being here,milan and Arun.
Arun Swaminathan, Ph.D. (00:54):
Thank you.
Ben, thanks for having us.
Ben Comer (00:57):
And that's Milan, not Milan.
I'm going to get that rightbefore this conversation is over
.
Milan Kalawadia (01:02):
It's quite all right, quite all right.
Ben Comer (01:05):
Thank you.
I thought that we could startoff with a little bit of
background on both of you, as wedo on the business of biotech.
You've both risen to the verytop of your respective
organizations and I wonder ifyou could just take a couple of
minutes to reflect on your pastexperiences and maybe the
specific circumstances that gotyou to this point.
(01:29):
What previous jobs prepared youfor leading Dr Reddy's and Koya
, respectively, and Millen,maybe we'll start with you, if
that's okay.
Milan Kalawadia (01:39):
Yeah, sure so appreciate the opportunity to be
here with Arun and yourself,ben.
Yeah, sure so appreciate theopportunity to be here with Arun
and yourself, ben, very excitedfor today's conversation.
But to get into the crux of itin your first question, so I'll
start backwards.
So, yes, I'm North America CEOof Dr Reddy's.
I've been with the company forover 19 years now.
(02:00):
But if I go back to thebeginning, I was an undergrad
out of Rutgers University.
I got a degree out of thebusiness school that essentially
set me up for consulting, and Idid consulting for a couple of
years Deloitte Consulting on thesystem side it was during the
era of which dot-coms were thebig buzz was then decided to
(02:22):
join a few startup companieswith the hopes of retiring early
.
Didn't quite work out, ended upgoing back to grad school, got
my MBA from Carnegie Mellon andthen worked at Merck
Pharmaceuticals for a couple ofyears in the finance capacity,
joined Dr Reddy's in 2006 in arole in our finance department,
(02:43):
and then my journey from therehas been tremendous.
Was in North America at a timewhen the company was probably
about 45, 50 employees, about 60million in revenues, and we had
just entered the US market backin 2003.
So a few years before I joined.
So I joined at a time wherethere was tremendous opportunity
and growth.
We entered as a retail genericsbusiness.
(03:05):
I was able to move from financeinto many different roles.
As I stated, I got theopportunity to spend about four
or five years in businessdevelopment where I started to
get exposure to many of ourbusinesses, ultimately moved
into an operating role where Iwas running our marketing group
for our private label OTC andthen started to add
(03:26):
responsibilities related to someof our other commercial
entities.
Our hospital institutionbusiness took over P&L
responsibilities for both theprivate label OTC hospital
institution and then ultimatelythe RxGenerics.
And along the way I had theopportunity to do many other
things as well.
I spent time in running NorthAmerica IR when we were at the
(03:47):
early stages of doing US IR,investor relations, took over
customer service portfolio, andso when you ask the question
about how did my career set meup for the role I'm in, I would
say predominantly twofold.
One early stage of my career wasthe mindset around being
entrepreneurial, strategic,trying to find opportunities,
(04:10):
doing what it takes to win.
The Dr Reddy's experiencehelped groom me to get through
different roles andresponsibilities that ultimately
set the stage for me to havethis opportunity, which I've
been in for a little over a yearnow, which is responsible for
North America, a business that'snow 1.7 billion plus in
revenues, about 300-ishemployees within North America,
(04:33):
which includes US and Canada,and looking forward to driving
future growth in a couple of ourother additional areas beyond
the base businesses of privatelabel OTC, hospital institution
and retail generics.
And those growth businesses areour self-care wellness division
and our biosimilars division,and we'll get into more details,
I'm sure, through thisdiscussion around how the
(04:56):
partnership with COIA is areally good intersection of
where Dr Reddy is headed and howwe got to that partnership.
But that's a bit about mybackground and appreciate you
giving me that opportunity.
Ben Comer (05:08):
Yeah, that's perfect, Milan.
Thank you so much for that, andwe'll definitely get into the
partnership.
And also, you know, I have aquestion or two, maybe just
about the evolving biosimilarslandscape too, that I might try
to sneak in.
But, Arun, let's talk aboutyour background.
And oh, last thing, Milan, thisis your first CEO role, is that
right?
That's correct, okay, all right, excellent, all right, Arun,
(05:31):
take it away.
Arun Swaminathan, Ph.D. (05:33):
Yeah, no, thank you, Ben.
It's a pleasure to be here onyour show with Milan and you
Appreciate the opportunity.
I'm currently the CEO of CoyaTherapeutics and what excites me
and I think that has defined mycareer is the intersection of
science and business, and you'llsee that, both serendipitous
(05:53):
and through my own plannedapproaches, that's exactly what
I've gravitated towardsthroughout my career.
Going backwards, I'm apharmacist by training and I
also got a PhD from theUniversity of Pittsburgh in
transplant immunology.
So that's kind of my academicbackground.
(06:13):
That led me to places likeBristol-Myers Squibb and I say
this quite a bit.
I grew up at Bristol-MyersSquibb and what I mean by that
is Bristol-Myers Squibb, becauseof the size of the company
allowed me to get experiencesacross a spectrum of things.
I started by designing andrunning clinical trials, because
(06:35):
I was a clinical pharmacologistby training.
So I got to understand how thatworks.
How do you design them, how doyou get them going, what does it
take to get IND approvals andFDA approvals, et cetera.
So I was directly involved intaking one product all the way
from IND to an NDA filing fromthe scientific perspective.
(06:56):
But that also got me exposed tothe commercial side of the
business side of the business,and then I did multiple roles in
commercial strategy, marketing,brand lead roles as well as
business development roles atBMS.
All of that kind of gave methat foundation, a solid
(07:22):
foundation to be able to do whatI've been doing the last 10
years, which is really makinggood science come to life, and
that's kind of what I'mpassionate about Last 10 years.
Briefly, I started I got theentrepreneurial bug, co-founded
a biotech company about 10 to 11years ago, so that was the
start of my small companyjourney.
Since then I've been in theC-suite of small public biotech
(07:47):
companies, koya being my fourthcompany that I'm at in the last
10 years.
I gravitated to Koya because ofexactly what I was telling you
before, ben, which is that itwas a perfect intersection of
science and potential and marketpotential for me.
I could see the value of thescientific approach.
(08:08):
I could see the elegance andsimplicity of our approach,
which hopefully we'll talk about, and that's what got me excited
.
I joined COIA two and a halfyears ago as a chief business
officer and had theresponsibility to successfully
complete the businessdevelopment deal and bring Dr
(08:28):
Reddy's on as our partner, whichwe are extremely grateful for,
because it's been such avalue-creating partnership for
us.
And then I assumed the role ofthe CEO about I want to say
about nine months ago.
Ben Comer (08:42):
All right, all right, yeah.
So leading small publicbiotechs is not a job for the
faint of heart, as you well know, arun.
You know what I'm hearing incommon from both of you is that
you've both worked across anumber of different functions in
life sciences companies, whichI suspect has set you up quite
(09:03):
well for the CEO role, and howmultifaceted it is, and we'll
maybe talk some more about that.
But I want to go back to you,mellon, for a moment here.
Dr Reddy's Laboratories isknown, I think, primarily for
manufacturing generic drugs,biosimilars, api,
(09:24):
over-the-counter retail products, as you mentioned.
But today we're talking aboutan innovative combination
product that Koya is developing,that Dr Reddy's will
commercialize.
And before we get into Koya 302, can you kind of talk a little
bit, millen, about what thisdeal means for Dr Reddy's and
(09:47):
kind of the thinking behind it?
Milan Kalawadia (09:50):
Sure, ben, I appreciate the opportunity to
address this.
For Dr Reddy's, yes, we are anAPI company moved in to finish
formulations and generics In theearly 2000s we got into
biosimilars and first starteddeveloping and selling
biosimilars into the emergingmarkets.
But there's always been a highlevel of interest and effort
(10:14):
that has gone behind innovativescience and innovative medicine
within the company.
And if I take it back to ourfounder, Dr.
Anji Reddy, he always had thedesire and the passion to launch
an innovative asset out of DrReddy's, and so that transpired
(10:34):
over the years.
There were a few efforts thatwe had gone down the path of,
not as successfully as we wouldhave liked.
To date, however, there's stilla high level of interest and
focus on innovative science, andso when I think about the
transaction or the partnership Ishould say with COYA, it was a
(10:55):
nice intersection of some of ourcapabilities with our desires
to get into innovative science,but then also tying it back to
Dr Reddy's and our purpose andour mission.
So one of the areas that DrReddy's is really focused on is
bringing solutions and productsthat can help meet unmet medical
(11:16):
needs, and the segment thatCOYA 302 actually helps address
is ALS.
It's an area that, as we know,has had very few products that
have come to market that areable to address the disease
state, and so it was a veryexciting opportunity to discuss
(11:39):
with Arun and team, and as westarted to dig into it, started
to align more and more with howthis is an asset that would be
one that Dr Reddy's couldactually partner with Coya and
help make a huge success.
And so when I think about yourquestion and how this is key for
Dr Reddy's, I think it's thenext evolution of our journey.
(12:03):
We are moving from, orcontinuing to be, a generics
player.
Moving into biosimilars butnovel products and new
development efforts is the nextwave, and Coya 302 fits in
nicely with that.
Ben Comer (12:19):
Yeah, I definitely want to pick up on this new kind
of adventure in innovativemedicines with Koya 302.
I have a quick question though,about the kind of evolution of
the biosimilar space which is.
You know.
I've seen a number of differentand this is more of a
commercial question, I won'tspend a lot of time on it, but
(12:40):
I've seen different approacheswhere a company and this is
maybe particular to the USmarket, but companies going in
with a biosimilar that is pricedat, you know, not much of a
discount off of the brand name,and then biosimilars coming in
at a pretty steep discount tothe brand name.
And I think the thinking thereis, you know some of the PBMs
(13:02):
prefer the higher pricebiosimilar, which they will.
Then you know the companieswill then discount and you know
the PBMs can make money off ofthat versus, I would assume, in
emerging markets the kind oflower price and maybe in parts
of the US or certain healthsystems or insurance plans, the
lower price is more effective.
I'm just curious, millen, kindof top level, what you're
(13:24):
thinking is in terms of how thatis evolving, the landscape for
biosimilars pricing, and ifthere's one strategy that you're
finding leads to better patientaccess to biosimilars.
Milan Kalawadia (13:38):
So specific for the US market.
Ben Comer (13:40):
Yeah, sure.
Yeah because I think with thehigh-low, you know playing with
the price.
I think that's probablyspecific to the US.
Sure, yeah, because I thinkwith the high-low, you know
playing with the price.
I think that's probablyspecific to the US.
Milan Kalawadia (13:48):
Yeah, yeah, so probably be a little bit broad
in the response here.
But Ultimately with any productlaunch it's market dynamic
dependent, and so in thebiosimilar space there are two
distinct segments.
There's the medical benefit andthe pharmacy benefit side.
Those two segments operate verydifferently and so pricing is
(14:11):
dictated by the segment withinwhich the products align, and
then it's also dependent on thenumber of competitors that come
to market on a given product ata given point in time.
So strategies evolve.
I don't think there's onecookie cutter response to your
question in terms of it's goingdown a particular pathway.
It's product to product,specific and unique to the
(14:32):
channel within which the productis placed.
Ben Comer (14:35):
Okay, all right, thanks for that, Arun.
Let's get back to COIA-302.
But first I wonder if you couldprovide a kind of high-level
explanation of COIA Therapeuticsdevelopment, work in multimodal
Treg therapies and maybe thekinds of diseases and
therapeutic areas that COIA istargeting.
Arun Swaminathan, Ph.D. (14:58):
Yeah, certainly Ben.
So our focus at Coya, ourvision, is to make devastating
neurodegenerative diseaseslivable diseases.
Today, most of these diseasesare a rapidly declining quality
of life issue for patients, andwith many of these diseases the
(15:20):
lifespans are significantlyshortened as well.
With ALS, for example, theaverage ALS patient lives three
to five years after diagnosisand in that three to five years
they are rapidly declining intheir physical ability.
So that is what we want totransform.
We want to bring solutions tothe market that hopefully allow
(15:42):
these patients to lead a normallife.
So our focus isneurodegenerative diseases and
what we fundamentally focus onis neuroinflammation.
What we know, ben, is that whenneuroinflammation is high, it
is directly correlated withprogression of many
(16:03):
neurodegenerative diseases, likeALS, like FTD, alzheimer's,
parkinson's, right, and so webelieve that slowing down or
stopping the neuroinflammationand its source is the way to
stop the progression of thesediseases.
To be clear, we're not talkinga cure yet.
We are talking about stoppingthe progression of these
(16:25):
diseases, which, by the way,nothing there currently does
that and not even remotely closeto stopping the progression.
So we would love to see thathappen.
And the way we addressneuroinflammation is by
addressing the regulatory Tcells, as the name implies, they
are immune cells that regulatesomething.
(16:46):
They are kind of the brakes ofthe immune system, right?
They basically say to theimmune system don't go at 100
miles an hour, you should begoing at 20.
And when that happens, there'sa good the good cells are not
being attacked.
What happens inneurodegenerative diseases is
these Tregs, which are thebrakes, are not functional and
(17:09):
then the T cells and the rest ofthe immune system starts
attacking healthy neurons ornerve cells.
When this happens, basicallyour internal spark plugs are
misfiring, right, which is whatthe neurons and nerve cells are,
and this leads to theprogression of neurodegenerative
diseases.
So we, our whole focus is onmaking these Tregs functional
(17:35):
and keeping them functional in adurable manner, and that's
exactly what we do with COYA-302.
COYA 302 is a proprietarycombination of a low-dose
interleukin-2.
On its own, interleukin-2 willincrease.
Low-dose will increase thenumber and function of Tregs,
(17:55):
which is what we want.
But the CTLA-4 is a criticalcombination, because what we do
with CTLA-4 is keep theinflammation driven by the
myeloid cell, by the macrophages, also low.
And that's because the CTLA-4acts on a different mechanism,
by acting on CD8086.
(18:17):
Because the CTLA-4 acts on adifferent mechanism by acting on
CD8086.
So we're acting on two aspectsof the immune system that then
keep that balance.
One allows for the Tregsnumbers to go up and the
functions to go up and the other, in combination, allows for it
to stay anti-inflammatory, themacroenvironment, thereby
keeping the Tregs functional forlong, which means it should
(18:39):
translate into durable clinicalefficacy.
And that's what we have seen insmall investigator-initiated
trial that was conducted, thatwe are seeing that we're able to
keep ALS patients fromdeclining.
At six months a small IIT studyand at one year there was very
minimal decline when normallythese patients would have
(19:00):
declined pretty dramatically inthat same time period.
Ben Comer (19:04):
Right, and a component of COYA-302 is
abatacept, a drug that you knowis, I believe, Coya in-licensed
from Dr Reddy's.
Initially it's a biosimilar ofBMS's Orencia.
It may also be in developmentat Dr Reddy's as a biosimilar.
(19:27):
I'll check in with Milan onthat.
But I want to hear how thispartnership came together.
It sounds well.
Well, I'm assuming that itstarted with the in-licensing of
abatacept but, um, Arun, maybeI'll stay with you for a minute
and then I'll get um and thenI'll uh, I'll ask um uh melon to
(19:48):
chime in.
But um, how did this cometogether?
And you know how?
Who, who had this idea that Dr.
Reddy's would ultimatelycommercialize this product.
But let's hear the Coya storyfirst.
Arun Swaminathan, Ph.D. (20:01):
I'll give you the Coya side of it.
I think Milan said it earlier.
The intersections that the twocompanies have was a natural
synergy, One you just pointedout abatacept is one of the
components of COYA-302, and DrReddy's is manufacturing
(20:22):
abatacept, so that's just numberone, a very natural synergy
right there to be in the nextwave into more innovative
therapies.
We were aware of that as well.
Dr Ellison has publicly statedthat.
And the synergy between the twocompanies in terms of our
(20:49):
ability to bring to the tabledifferent skill sets, different
capabilities, where we felt thatone plus one is going to be
better than two.
And I think we are alreadyseeing that in the one year of
our partnership.
And that's what brought us tothe table together.
And so it was kind of a naturalprogressive conversation that
happened between the leadershipof Coya and leadership of Dr
(21:12):
Reddy's.
It kind of made intuitive senseto both sides and it was very
clear that both sides are goingto create value together and,
more importantly, together wecan bring this therapy hopefully
faster to patients, and that'sreally what drove all of this.
And there's a common missionthat we have that we want to
bring address unmet needs forpatients.
(21:34):
I'll let Milan give the DRLside of the story.
Ben Comer (21:39):
Yeah, and Milan, before I turn it over to you, I
just had a quick question aboutOrencia, arun, kind of from a
scientific level.
Were you familiar with Orencia?
You know kind of as you werethinking about, you know the
development of 302, was thatsomething that you had kind of
hands-on knowledge of?
(21:59):
Was there overlap of that drugwith you at BMS?
Arun Swaminathan, Ph.D. (22:03):
Yes, Ben.
I was on the launch team ofOrencia way back in 2005 as a
junior marketing person onOrencia soon after the launch, I
should say and then I was alsothe worldwide brand head and
director for Orencia.
So I'm extremely familiar withabatacept, with Orencia.
(22:27):
Of course, my focus was onmarketing Orencia for patients
with rheumatoid arthritis, whichis the primary indication
Orencia was approved for.
I was also involved in Orenciawhen it transitioned from an IV
to sub-Q presentation as well,so I have deep knowledge of
(22:47):
Orencia from my Bristol-MyersSquibb days.
Ben Comer (22:51):
Okay, that makes a lot of sense.
Milan, what made Dr Reddy'sdecide we're going to
commercialize this quite noveldrug mechanism, an innovative
product?
It seems like something of adeparture.
But yeah, how did that?
What's the Dr Reddy story?
Milan Kalawadia (23:11):
Sure, sure, yeah, absolutely does seem like
a departure from where we are attoday, but not where we're
headed.
But before I get to that, youknow what started as a
discussion between Koya and DrReddy's around what could have
been a simple supply deal toprovide a Badasept evolved as we
(23:33):
started to engage in dialogueand conversation.
As we started to engage indialogue and conversation, arun
and team obviously shared avision, shared the insights on
the project and the work thatthey were doing with our
business development team, andthere seemed to be a good
opportunity here, which thenrequired deeper diligence, a
little bit more understanding ofthe journey that Koya and team
had been on the foundationalwork that they've done to date
(23:55):
to actually start the program,to then now get to the point
where, uh, that abitasa was nowrequired as part of the broader
landscape, and so it was reallyexciting for us was a project
that we were working on, waspotentially going to have an
opportunity to serve a biggerpurpose, and so so, connecting
(24:15):
with Arun and Koya and findingan opportunity to take our
Abitacid program, which we werein the process of taking forward
for the US market as abiosimilar R&D efforts were
underway, commercialgo-to-market strategies were
being devised, then had theopportunity to now serve yet
(24:37):
another purpose and also meet anunmet medical need, like we
talked about earlier, which isto treat ALS patients.
So when we go back to theintersection of the deep science
that Koya worked on, to thedevelopment work that we were
doing for a biosimilar asset, tothen the commercial aspirations
and Dr Reddy's desire to getinto innovative assets, it was
(25:01):
great timing for one, but thenalso a great opportunity.
And so, while it may seem as adeparture Ben, we're already
going down the path of buildingcapabilities for our biosimilars
.
We're in the process.
We were at the early stageswhen we first signed the deal,
but where we sit today, we havea team in place that's working
on the infrastructure build-out,that's preparing for a
(25:24):
biosimilars launch, that'sworking towards commercializing
an asset in a branded fashion.
Now biosimilars, different thangenerics, are going to require
market access teams.
They're going to require afield force.
We have a in-house marketingdepartment, so we're building
out capabilities.
That also leads us down thepath of being a good strategic
(25:47):
partner for Koya and to enterinto this relationship to
commercialize the asset, becausetiming will be quite optimal in
the sense that we will havelaunched.
Our biosimilars are notgenerics.
You do need a market accessteam.
Ben Comer (26:15):
You may need even a sales force to go out and talk
to physicians.
You may need a kind of keyaccounts manager for payers.
It's a very differentexperience, right than marketing
and selling a small moleculegeneric drug.
Okay, that makes a lot of sense.
As far as Arun, next, I havekind of a funding question for
(26:40):
you and I remember you know theIce Bucket Challenge and ALS
probably one of like the biggest, most successful fundraisers
for any disease state.
But you know, here we are stilltoday without a really
effective treatment for ALS.
It's no surprise to anyone thatit's a very difficult
(27:01):
environment in the publicmarkets right now.
It's not easy to fundraisereally for anyone in early
stages of development.
What kind of I guess, strategicrationale would you give for
licensing COIA-302 to Dr Reddy'sfor commercialization and does
(27:21):
that actually help you progressthe asset?
Arun Swaminathan, Ph.D. (27:24):
First, 100%.
I think our partnership enablesto advance the asset more
efficiently and also in a morerigorous manner, because we now
have the power of Dr Reddy'sthought process and expertise as
well.
The power of two brains, twocorporate brains is better than
(27:44):
one any day and we fullyleverage that.
And I think it's a no-braineranswer for me that, yes, it
absolutely creates value.
As far as the capital markets,you're right, Ben.
I mean it's a tough market forbiotechs.
It has been a tough market forbiotechs the last few years and
(28:06):
that was part of our rationalealso to enter into a partnership
with Dr Reddy's, with ALS.
What we have been able to dothrough that partnership is a
couple of things.
One is it just made more senseto put this product in the hands
of somebody like Dr Reddy's andMillen's team that has the
(28:26):
sales force, that has thecommercial experience, that has
PVM teams and managed care teamsthat can address a lot of the
things that COIA doesn't havethe infrastructure to do.
So it just made a lot of sensethat we don't do that ourselves.
I'm a big believer thatstrategic deals are about
(28:47):
leveraging do what you're goodat and let somebody else do what
they're good at, and I thinkthat's what we're doing here.
And then the second thing from acapital market is that I mean,
I don't know if the marketagrees with me I do think we
have removed an overhang that alot of small biotechs have.
When they get approved, whenthe BLA is good, immediately the
(29:11):
market goes okay.
Now Koya is going to have tospend millions and millions and
millions marketing this, but wehave taken that off of the first
indication, ALS, because wehave a strong financial partner
in Dr Reddy's who will beresponsible for commercializing.
So there is that benefit.
Definitely that wasn't the mainreason we did this partnership,
(29:34):
but I think it is a byproductof it for sure, and that has
helped us with the capitalmarkets.
It has helped us stay cashefficient with the support of Dr
Reddy's, and we are, for asmall biotech company, in a
relatively good cash positionwhen you compare us to a lot of
our peers, and I think that haspartly been possible because of
(29:56):
this strategic partnership.
Ben Comer (29:58):
Yeah, and then on manufacturing, you know
obviously Dr Reddy's is morethan capable of scaling up
Abatacept manufacturing for latestage clinical trials.
What about the other componentof 302?
Are you in the process now ofscaling up that manufacturing,
and is that actually done by aseparate CDMO or by COIA
(30:23):
internally?
And how does that, I guess,work, just thinking about
needing to create more of COIA302 as the drug progresses into
the final stages of clinicaltrials?
Arun Swaminathan, Ph.D. (30:36):
So the clinical supply we have lined up
and it is from a CDMO that isoutside of Dr Reddy's.
I'm going to hold fromspeculating or sharing with you
because we haven't publicly doneso on our plans for
commercialization, but it goeswithout saying we work very
closely with Dr Reddy's on howand when we would do that
(30:59):
manufacturing of the low-doseIL-2 as well, but the CTLA-4
obviously already ismanufactured by Dr Reddy's.
And you brought up a very goodpoint, ben.
Among lots of the synergieswith Dr Reddy's is also their
expertise in manufacturing.
It's not the core strength ofCOIA.
We are not a manufacturingcompany.
(31:21):
We are advancing the science ofTregs, understanding
neuroscience, understandingclinical trial design company.
So the two things come welltogether when you think about
our two companies and I thinkyeah, I think that's what I can
appropriately say at this point,obviously at the right time,
what Dr Rennes and us will sharein more detail how we are
(31:44):
preparing for commercialization.
Ben Comer (31:47):
Great and Milan, you've talked about how COYA 302
, commercializing COYA 302, iscomplementary to some of your
other lines of business, inparticular biosimilars and the
capabilities that you're alreadyin the process of building
there of its innovative drugfrom you in the very beginning.
(32:15):
But do you see this as ajumping off point for
potentially futurecommercialization deals with
other innovative companies andother innovative brands?
Are you making those plansalready, or is that something
that you're going to look at ina kind of opportunistic way or
no?
Arun Swaminathan, Ph.D. (32:39):
I think the simple answer is yes, it's
an opportunity.
As we think about evolvingbusiness models.
COYA 302 is the focus, however,from a space to play with
innovative assets.
As I stated earlier, is an areathat has been of interest to us
, and so we are in early stagesof going beyond just a single
(32:59):
asset, type of environment andlooking strategically on how
best to move forward andcontinue to build and evolve in
novel products, and so I'llrefrain from maybe sharing much
more detail, but it definitelycreates an opportunity for us to
now continue to evolve thisside of the business Right.
Ben Comer (33:19):
Ok, so you don't have any kind of set product goal.
You know we're going tocommercialize X number of
innovative drugs in 2026 or 27or 28.
Milan Kalawadia (33:29):
At this point, yeah, no, we we from sharing
forward-looking statements suchas that as a company, and we
have not stated specific targetson how many products we'd be
looking to launch by certainperiods of time, but simply
stated this is an area of thebusiness that we want to
continue to focus on and grow.
Ben Comer (33:52):
Excellent.
We've talked a little bit aboutCoya 302 and how it's different
, Arun.
It's a combination of twoseparate active components
coming together.
The lead indication is for ALS.
Is there anything else I guessyou would share about other
(34:12):
indications or future plans for302?
Yeah, let me just leave itthere.
What else is happening in termsof development?
Is it in parallel?
Will you go for this kind offirst approval in ALS before
looking at advancing otherclinical programs and other
indications?
(34:32):
Sorry, I put a lot of questionsin there at one time for you,
Arun.
Arun Swaminathan, Ph.D. (34:37):
No, that's perfectly fine, ben.
Yes, our priority is ALS.
So I think we want to first getALS advanced, which hopefully,
once we receive the green lightfrom the FDA, which we
anticipate in the next 7 to 10days, we'll hopefully be able to
(34:57):
initiate that potentiallypivotal phase 2b study in
patients with ALS.
So that is our number onepriority for 2025.
However, as I previouslymentioned to you, our mechanism
will absolutely work infrontotemporal dementia and
other diseases as well.
So our second indication ofpriority, if I can call it in
(35:22):
order, is frontotemporaldementia.
We fully intend to submit anIND to the FDA on FTD towards
the end of this year, once ourALS trial is up and running.
That's our current plan and wehave publicly disclosed that and
then, if all goes well, we willinitiate a small phase 2B study
(35:44):
that will have been funded,partly at least, by the
Alzheimer's Drug DiscoveryFoundation sometime next year,
in the first half of next year.
That's kind of our two areas offocus On Alzheimer's and
Parkinson's disease.
Right now we are focused onalso a different acid, coya-303,
(36:06):
which is a combination withGLP-1 agonists, the popular
weight loss drugs that have thepotential in diseases like
Alzheimer's disease.
Of course, as you may be aware,there's going to be some
significantly big readoutscoming out of no one, nor this
semaglutide towards the end ofthis year on the two big trials,
(36:27):
evok and EVOK+, that they'reconducting in patients with mild
Alzheimer's disease.
So I do think that opens up alot of value creating potential
for COIA in the Alzheimer'sdisease space.
But our immediate priority forCOIA-302 is ALS.
Number one hopefully get theFDA green light, get that trial
(36:49):
started, followed by frontaltemporal dementia.
We have showninvestigator-initiated trial
data in a very small group ofFTD patients that we do
something similar to what we'veseen in ALS, which is we stop
the cognitive decline in thesepatients.
In the case of FTD it'scognitive function as opposed to
(37:09):
physical function more, andwe've shown that we're stopping
it.
And, more importantly, we'reseeing that the science plays
out.
We see Treg numbers andfunction improve with this
combination IL-2 plus CTLA-4,and staying durable.
And then that translates to thebiomarkers moving the right way
and then that is translated bythe small study to the
(37:33):
stabilization of the disease.
And that's what we like to seeas a scientific company is that
everything lines up.
That increases our confidence,one in the outcome, the
probability of technical andregulatory success in ALS as
well, and in other diseases aswe move forward.
Ben Comer (37:52):
On the combination with the GLP-1, is that one?
Are you kind of lining up thatclinical program with being able
to market maybe semaglutidespecifically?
Are you looking at other youknow active GLP-1 ingredients, I
guess how are you thinkingabout that?
You know the potential patentexpiry of semaglutide and then
(38:13):
how you move that in if that isindeed you know the molecule
that you're targeting.
Arun Swaminathan, Ph.D. (38:18):
So we're keeping our options open
on the GLP-1 pen.
But what we have generated todate is data with semaglutide
and with exenatide and we'veshown that semaglutide plus
COYA-301, which is herproprietary low-dose IL-2, is
synergistic in neuroinflammatorymarkers.
(38:39):
This is all preclinical,non-clinical work, so obviously
we'll have to show anddemonstrate this at some point
in the clinic.
But you know we're not and ofcourse we do have IP around it.
So we have the patent rights tothe combination of flow dosing
from looking to with any GLP-1agonist, not just 7-WP.
Ben Comer (39:00):
Got it, thank you.
Thank you for that.
Milan, I want to come back toyou on the commercial launch us
a lot of information about howyou're approaching this,
building out sales teams thatwill have kind of double duty,
being able to sell biosimilarsas well as Coya 302 once that is
(39:21):
approved.
But can you talk about how youbuild up those capabilities and
kind of where you're focused on?
I mean, are there any key newhires that you're making?
Are you thinking aboutSalesforce size?
Are you thinking about, youknow, specific regions or even
ex-US opportunities at thispoint?
Milan Kalawadia (39:41):
Yeah, no great question All of it.
So we've been on a journey inthe US and we have been
fortunate to find some greattalent in the market that has
joined to help us evolve ourcommercial infrastructure,
(40:02):
internal marketing capabilitiesto pricing analytics, and then
also focusing on market access,and I'll call it field force
design and ultimate accountmanagement.
(40:22):
And so we are being verymethodical in our approach.
We're looking for, one, theright talent, but two, the right
approach to actually go tomarket and commercialize.
We've had discussions around dowe build the in-house
Salesforce?
Do we go contract Salesforce?
Are there other partnershipmodels that we can evolve?
And so those discussions are ata very mature state At the
(40:47):
moment.
When it comes to hiring, thereare probably a few more key
talents that we need to bringinternally, but we have decided
that, from a Salesforce designperspective, we are staffing for
the US.
We have done our field forsizing, but we're going to do it
through a third-party model atthe time.
At this time, at a future pointin time, as the business
(41:11):
evolves and grows, chances arewe would internalize, but at the
moment it's going to be athird-party approach.
And so we're constantly lookingat the business model, the
go-to-market strategy, evolvingit to make sure that we're
nimble, but setting ourselves upfor success, and so I'm very
confident at the approach thatthe team has been undertaking,
(41:32):
and we're very excited for ourfirst biosimilar launch, which
is should, if all goes well, benext summer, followed by a
potential abatacept launch inthe year after, and so a lot of
work is underway, but we will beready for those launches, as
well as the future launch ofCOYA 302.
Ben Comer (41:53):
Okay, and you just answered a question that I had
that I had kind of forgottenabout, which is you are also
developing, you know, inparallel, a kind of a biosimilar
, or, you know, pushingabatacept forward as a potential
biosimilar to Orencia, at thesame time as Coya is developing
302.
Arun Swaminathan, Ph.D. (42:14):
That's accurate, that is correct, and
there is a broader pipelinebehind the biosimilars business
as well, but abatacin becomesthe first major molecule that
will launch under that division.
Ben Comer (42:27):
Great, excellent, Arun, I want to come back to you
for a question on IP.
Obviously, it's a criticallyimportant function of value for
a biotech.
You've got a unique product onyour hands.
What can you tell me about Coya302's intellectual property
(42:48):
holdings, and maybe just give mea sense of what those are?
Arun Swaminathan, Ph.D. (42:53):
Yes, Ben, COYA 302 actually has a
very strong IP portfolio.
I like to call it like an onion.
We have a complex series of IPthat protects COYA 302 in a very
robust manner, with the averagelife of the intellectual
property going well into the2040s.
So we are well protected.
(43:15):
And I'll explain to you why.
There's really three keyreasons.
One we have a proprietarylow-dose interleukin-2.
The patent was granted and wepublicly disclosed that in June.
So we have the aqueous low-doseinterleukin-2, and the methods
around it is part of ourintellectual property rights.
(43:36):
What that allows you to do isit allows you to administer
low-dose IL-2 as a subcutaneousadministration.
The currently available IL-2,which is used in the oncology
indications at a much, much,much higher dose, is a
lyophilized, freeze-driedpresentation that needs to be
then reconstituted and it'sadministered intravenously.
(43:59):
So we have enabled, through ourintellectual property, the
administration of IL-2 in aself-administered or, in the
case of ALS patients, likelycaregiver administered, but it
can be done at a home setting.
So that's IP number one.
We also have intellectualproperty around the combination
of any interleukin-2, includingmutines, spegulated long actings
(44:24):
, with any CTLA-4 inhibitor.
So that gives us a powerfulprotection around COYA 302.
And to wrap it around.
We have some additionalbiomarker patents on ALS that
also give additional protectionfor COIA-302.
And so there's very strong IPand, assuming that one gets an
(44:49):
Orphan Disease designation,these diseases definitely
qualify Outside of the IP.
The FDA tends to grant aseven-year commercial
exclusivity for those types ofproducts as well, so we feel
pretty good about the ability toprotect COIA-302 commercial.
Ben Comer (45:09):
Got it.
And just to clarify, COYA 302will ultimately be a sub-Q
administration that can be donelike, say, by an ALS patient,
his or herself or a familymember.
It doesn't have to be ahealthcare practitioner.
That's giving it.
That's an important, I think animportant attribute for the
(45:31):
product potentially.
Arun Swaminathan, Ph.D. (45:32):
Exactly , Ben, and that is key to
understand is that thepresentations and that's how we
are designing the clinical trial.
The clinical trial will be donewhere, after the first
administration or so, thepatients are trained or their
caregivers are trained and theyadminister it at home.
And these injections are nodifferent than the current
Orencia injections or GLP-1injections.
(45:56):
They're easy.
It's not like complicated,they're not slow infusions or
slow sub-Q, it's a single shotadministration which makes it
very easier for the patient tonot have to go to the clinic or
that kind of setting to gettheir dosing done.
Ben Comer (46:17):
Got it.
And then, speaking of clinicaltrial design, could you describe
what kind of engagement Arunthat you and Koya have had with
the FDA?
Have they, you know, have theybeen instructive and, you know,
offering guidance, or, you know,have you had other
conversations with them aboutTregs?
(46:40):
Where does that kind ofrelationship stand, if I can put
it that way?
Arun Swaminathan, Ph.D. (46:44):
I mean we have had multiple
interactions with the FDA andwhat I can say is the FDA is
extremely collaborative.
I think the FDA has the samemission we all have, which is to
bring better options topatients.
Through the last year we havehad discussions with them on the
data needed for them to say,okay, you can go ahead with your
(47:05):
phase 2B trial.
We've had good alignment withthem.
We have submitted that data.
We anticipate a response fromthem in the upcoming week, a
week or so.
So it's been a pretty goodengagement and, from our
experience, as part of that,obviously the clinical trial
protocol is part of that.
(47:26):
So we do get feedback from theFDA on our design.
So by the time we get all thisstarted, we are aligned with the
FDA and we'll have confirmationthat we're aligned, hopefully
in a couple of weeks with theFDA.
So it's been a verycollaborative process and we
have not seen anything differentin our interactions with the
(47:48):
FDA.
And I'll add that ourregulatory submissions are also
strengthened through ourpartnership with DRL, because we
do leverage their regulatoryexperts as we prepare these
documents that we submit to theFDA and other agencies as well.
Ben Comer (48:05):
Oh, ok, I'm glad you mentioned that.
That's an important resource,you know, I would imagine, for
any small biotech company tohave access to regulatory
experts.
We are running short on time,but I want to get just a final
thought from both of you aboutkey priorities.
You know for the rest of thisyear, and maybe Arun we'll keep
(48:26):
it with you and then we'll endwith Milan, but you know what's
next for COYA-302?
You're going to hear somethingback from the FDA in a couple of
weeks, but you know what's thekey next step.
What's your top priority forthe rest of 2025?
Arun Swaminathan, Ph.D. (48:42):
Well advancing.
The clinical trial in ALS ispriority number one.
Obviously, that's contingent ongetting that green light from
the FDA, but that is our numberone priority for 2025, getting
that trial started in 2025.
Ben Comer (48:57):
And that'll be the Phase 3 trial.
Arun Swaminathan, Ph.D. (48:59):
It'll be a phase two B, okay, in 2025.
And that'll be the phase threetrial.
It'll be a phase two B, butwith ALS, the FDA has precedence
of approving products with justone trial because of the high
unmet need.
Of course, that'll be subjectto data and we'll have to have a
discussion with the regulatorybodies at the right time about
it.
But, yeah, there is precedencefor it.
So that is our number onepriority Get the ALS clinical
(49:20):
trial off the ground.
Number two is file the IND forfrontotemporal dementia after
that and then get ready to starta small trial in FTD in 2026.
And then, in parallel, we'lladvance our COIA-303 from a
preclinical perspective.
We have an ongoing animal studythat will hopefully further
(49:44):
strengthen our hypothesis aroundthe synergy and we should be
able to disclose that publiclywe hope in the second half of
2025 as well.
So these are some of the things, and we'll continue to generate
more data around biomarkers andprediction in these ALS and
other diseases as well in thesecond half of 2025.
(50:04):
But our number one priority isgetting the ALS clinical trial
started.
Ben Comer (50:10):
Got it and Milan.
What are your top priorities atDr Reddy's, for the rest of
2025?
Milan Kalawadia (50:17):
Yeah, so specific to the partnership we
have with COYA and 302,continuing to help progress the
outcome right.
So waiting for FDA feedback, butpartnering from a regulatory
standpoint as the productcontinues to evolve, engaging in
manufacturing-relateddiscussions to continue to or
(50:38):
continuing to ensure that we areready for success.
So that becomes, and continuesto be, a priority as it relates
to the partnership, the greatpartnership we have with Coya,
as I think, beyond thisconversation and the rest of the
business, a few differentthings that are priorities we
need to continue to drive ourbase business, drive growth out
(50:59):
of the base business, which isour generic portfolio here in
the US, putting a lot of timeand energy behind our growth
initiatives, which is the selfcare wellness space, as well as
the biosimilars which we spentsome time talking about today.
And then another criticalcomponent of the overall
priority list is we have aportfolio of GLP-1s.
(51:19):
We're actually in a position tolaunch our first GLP-1 in
Canada, which is semaglutide,and the preparations to ensure
that we are ready for day one.
Launch of that product inCanada is probably the top
priority at this point.
Ben Comer (51:35):
So, Arun, you've already got a supplier for your
semaglutide product, then Well,yeah, I mean, obviously we'll
have those conversations.
Milan Kalawadia (51:46):
I can't share any details at this point.
Ben Comer (51:49):
Thank you so much, both of you, for being on the
show.
We've been speaking with MilanKalawadia, CEO of North America
at Dr Reddy's Laboratories, andArun Swaminathan, Ph.
D.
, CEO at Coya Therapeutics.
I'm Ben Comer and you've justlistened to the Business of
Biotech.
Find us and subscribe anywhereyou listen to podcasts and be
(52:12):
sure to check out new weeklyvideo casts of these
conversations every Monday underthe Business of Biotech tab at
lifescienceleader.
com.
We'll see you next week andthanks, as always, for listening
.
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