October 20, 2025 • 33 mins
We love to hear from our listeners. Send us a message.
On this week's episode of the Business of Biotech -- part three in a four part series recorded in-person at Catalyst Pharmaceuticals' Miami headquarters -- Anthony Japour, M.D., CEO at iTolerance, talks about his work as a physician treating infectious diseases, his CEO role in diagnostics at the height of the COVID-19 pandemic, what he learned working as a medical director at a large CRO, and iTolerance's work toward a cure for Type 1 diabetes that doesn't require chronic immunosuppression. Anthony also provides insights on overcoming CMC challenges and how to bypass avoidable detours, the funding climate for preclinical biotechs, and operating in South Florida.
Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.
Subscribe to our monthly Business of Biotech newsletter.
Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.com
Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/
Mark as Played
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 we're in Miami,Florida, for a series of
episodes recorded on location atthe offices of Catalyst
Pharmaceuticals.
For this series, we're speakingwith individuals operating
companies regionally here in theSunshine State, and I'm happy
(00:27):
to welcome Anthony Japour, MD,CEO at iTolerance, a preclinical
regenerative medicine and celltherapy company focused on type
1 diabetes, liver disease, andlarge organ transplant.
Anthony has worked at BigPharma, at a big CRO, and in
diagnostics and in consulting.
(00:48):
He received an MD fromNorthwestern and did postdoc
work in infectious diseases atHarvard.
I'm excited to hear aboutAnthony's work at iTolerance and
the company's quest to delivertissue organoid and cell
therapies to patients withoutthe need for ongoing
immunosuppression, not tomention a potential cure for
(01:10):
type 1 diabetes.
We'll also talk about thebenefits and drawbacks of
leading a biotech in SouthFlorida, what's happening in
regenerative medicine, andwhat's next for iTolerance.
Thanks for being here, Anthony.
Thanks for having me, Ben.
I wanted to start off as we doon the business of biotech with
your background.
And we'll take it way back.
(01:32):
How did you get interested inlife sciences initially?
And why did you want to turnthat interest into a career in
medicine?
Anthony Japour (01:43):
Well, ever since I was four years old, I wanted
to be a doctor.
Really?
My parents were like, we have avery strange child.
I was walking around with thedoctor's bag.
So I've always wanted to be anMD.
My parents were 100% againstit.
They didn't have, well, myparents are both deaf, and they
tried to cure my mother of herdeafness through a lot of odd
(02:05):
things.
And so she just didn't have agreat appreciation for doctors.
So here she has a child whosays, I want to be a doctor.
And um, so I had a choicegrowing up.
I could be either a lawyer, anaccountant, or a dentist.
Those are my three options.
A dentist, but not a doctor.
Right.
Well, I had a greatrelationship with my dentist,
(02:25):
and my mother's like, Why don'tyou be a dentist?
It's a better lifestyle.
Doctors work too much.
Her OBGYN and our pediatricianwere brothers and they worked
from morning to night.
So she didn't really think thatthe medicine profession had a
good lifestyle.
So anyway, I was a veryobedient child, and it wasn't
really until I got to Harvardthe first time in dental school
(02:47):
after college that I realizedthat I was on the wrong path.
And I took off and had to dothe MCATs all over again because
I had done the dental boardsbefore, uh, and then got into
Northwestern and finished mydegree there.
Ben Comer (03:02):
Um that's a that's a great story.
You actually did pursuedentistry before uh moving over
into uh And there's a lot oftremendous technological
advances in dentistry.
Anthony Japour (03:12):
It's an amazing field.
It just wasn't for me.
I knew I was on the wrong path.
Ben Comer (03:17):
I I will just say one problem I have with dentistry
is uh I feel like for the lastat least 25 years, no, my whole
life, the things that they takeuh the uh the x-rays with that
you have to open and bite downon hurt my gums so much.
They're so uncomfortable havingme too.
Where's the innovation in thein that technology?
I'm with you.
(03:37):
I those are hard, it's sopainful.
I just can't believe that theyhaven't been improved.
That it hasn't been fixed rightnow.
It has to be a giant metalblock that goes in your mouth.
Uh I wanted to ask, you were amedical director at Icon,
correct?
Yes.
Um what did you learn about uhhow clinical development works
(03:59):
that maybe people who have neverworked at a CRO or a CDMO, you
know, might that they just mightnot know or might not
understand?
Anthony Japour (04:08):
It was a fascinating experience being
there, I must say.
I never thought I would work ata CRO.
But I was offered theopportunity.
I was here in Florida, and forme to go back into farm or
biotech meant moving either backto Chicago or to the Northeast,
which I didn't want to do.
So I was doing other thingsdown here, but when I got the
opportunity to take a remoteposition with icon, I said, oh,
(04:32):
why not?
Fascinating opportunity.
Why?
For me, I got to work in somany therapeutic indications.
I worked in C diff.
Um, I worked with the seriesproduct, the first product for
C.
diff colitis, the uh uh uh thefecal transplant.
Ben Comer (04:48):
The fecal transplant, wow, okay.
Anthony Japour (04:50):
So that was one fantastic experience I had.
I got to work with them withtheir product when it failed
phase one, looked at all thedata to figure out where the
error error was and how whatdiagnostics they should change
it to for the phase two, and itended up being approved based on
my recommendations to thecompany.
So that was just one standoutexperience.
(05:12):
And you know, being a molecularvirologist by training, you
really understand all the basicsof science.
So whether it's cardiology orinfectious disease, which is my
core competency, or even um HepC Nash, I got to work in Nash.
So that was really great.
What I learned about thebusiness of CRO versus pharma is
(05:38):
they don't have patents, theydon't have intellectual
property.
So their revenue model ispurely service.
Right.
And that puts them at adisadvantage because they want
to be paid for their time.
There's just nothing free at aCRO.
You pay, it's like a la cartemenu.
Uh, but um, it was a greatexperience.
I learned a lot, and I thinkI've made a big difference while
(06:02):
I was there.
Ben Comer (06:03):
Um speaking of infectious diseases, you had
another CEO role before becomingCEO of eye tolerance in 2021
during, or no, I think it was in2020 during COVID.
Uh you worked as CEO atAdvanced DX Um Biological
Laboratories, which I believewas a COVID molecular diagnostic
(06:24):
uh maker based in Europe.
Perhaps could you uh tell us alittle bit about what that
experience is was, you know, waslike uh working for a COVID
diagnostic company, you know,right at the at the very
pinnacle of COVID at that time.
Anthony Japour (06:41):
So my core competency, as I mentioned, is
molecular virology, right?
So that's what I did at Harvardin HIV.
I worked on the first uh essaysfor HIV drug resistance, HIV
RNA essays.
So that was going all the wayback to like the 80s and 90s.
So here I am at ICON being amedical director, and I got
(07:02):
offered this position to leaveto become CEO of a diagnostic
company that's working of thedisease of our time.
So there was no way I couldn'tleave ICON to take this role.
It was very interesting.
Um, the science, this was acompany that was already rooted
in uh virologic diagnostics, uh,but not in COVID.
(07:24):
They were working in HIV andspecifically HIV drug
resistance, which again was mycore competency.
My role was purely commercial.
All of the regulatory and thescientific work was coming out
of Europe.
And that was when we had theEUA, emergency use
authorization.
Um so the nice thing about, Iguess, my life in this field is
(07:47):
my relationships with mycolleagues.
So I had to put together acommercial team literally in a
month.
And because I had such greatrelationships with people, in
this case Roche, I just calledup my old colleagues and said,
How would you like to come?
I need sales marketing now.
And they had remembered me from20 years ago and they're like,
(08:08):
Are you kidding?
Yes.
And to work on COVID, yes.
So I was able to put together acommercial team very quickly.
Uh the frustrating part for mewas I had no part in the
regulatory side of it.
And my colleagues at AdvancedDX, um, which was based out of
Europe, didn't understand thatwhen you tell the FDA that
(08:31):
you're gonna give them data in10 days, and you don't give them
data in 10 days because you'redoing something else, they're
gonna put you at the bottom ofthe pile, which is exactly what
happened.
So we built out the commercialorganization.
I had contracts ready to go,just waiting for the EUA
approval.
But because EUA approval didn'thappen in a timely fashion, we
(08:55):
were not able to, we weren'table to market and sell in the
US.
Ben Comer (09:00):
Oh, that's too bad.
Um is there anything uh thatthat you remember, uh, just you
know, had a bird's eye view ofCOVID at the worst time of it
before a vaccine was available,I think, right?
Um and you were, you know,dealing with Europe, leading a
European company, um, you know,living in the US, were were
(09:21):
there differences that stuck outto you in terms of how people
were, I don't know, reacting toCOVID, adopting, you know,
diagnostics and therapeutics,anything that struck you as uh,
you know, a kind of black andwhite difference between Europe
and the US during that earlytime of COVID when, you know, it
was uh it was scary foreverybody.
Anthony Japour (09:44):
What's interesting is all of our
products were approved inEurope.
And we couldn't get themapproved in the US.
Yeah.
In part because of thebureaucracy.
Um and um, you know, so andthat was also the era of LDT,
laboratory diagnostic testing,where each lab could come up
(10:04):
with their own, which wascomplicating things.
What was good about it is Ifelt like I was making a
contribution in the infectiousdisease important issue of the
day that if I had stayed atICON, I would have felt bad that
I didn't get involved, sort oflike getting into the military.
I felt like I signed up.
But um Europe had a much morerelaxed way of getting the EUAs
(10:30):
for those diagnostic tests thanthe US did.
US was quite challenging.
Um, we also had both antibodytests as well as the PCR-based
tests.
And I just remember there was alot of frustration with
actually even getting productinto the US, like they held it
up at customs.
Uh so there was, but you know,we kind of rallied through and
(10:54):
uh we felt like we were making acontribution in some way, even
though we ultimately were notsuccessful.
Ben Comer (11:01):
Um let's talk about iTolerance.
Uh over lunch, you know, we wehad lunch together, uh, Anthony.
It's a big, big reveal for thethe podcast.
I'm down in uh South Florida,and what you know, we we all got
together.
But uh you mentioned that youwere the first employee at
iTolerance uh and that you hadtrouble recruiting for certain
(11:22):
positions, uh, you know,bringing people into South
Florida.
I wonder if you could um talk alittle bit about that.
Anthony Japour (11:29):
Sure.
Uh so after ABLDX, I was in norush to jump into another
position.
Um, in fact, it was about ninemonths between my two roles.
But one of the nice things ofhaving all this gray hair is you
don't have to jump from onething to the next, that you can
really wait.
And I think that was part ofthe discussion that we had, that
(11:50):
there's a tremendous pool oftalent here in Florida, of
people with a lot of experience,but they don't have to take a
job.
They're happy with what they'redoing.
And that's sort of where Ifound myself.
So when so I I had been doingum uh pro bono work with the
Diabetes Research Institute herein Miami because the FDA
regulates uh cadaveric donorislets as drugs as opposed to
(12:17):
donated organs, which theAmerican taxpayers paid over $20
million for the phase threestudy showing that cadaveric
islets can cure type 1 diabetes.
And it's approved in the entireworld and and compensated,
including China and Iran, butnot in the U.S.
Ben Comer (12:35):
And it's working as a functional cure for type one?
Yes.
It is a functional cure.
Why are we not hearing aboutthat here in the US?
Anthony Japour (12:42):
Well, so so I was so so I, you know, very
close to the people in theDiabetes Research Institute.
And when I had this period oftime when I was kind of free, if
you will, after ABLDX, I said,is there anything I can do to
help?
And they were showing me theregulatory communications
between all the transplantcenters in the country and in
(13:06):
the FDA.
And I realized that they wereapproaching it as academics,
physicians, surgeons who wantedto cure patients, but they
weren't approaching it from alegal, I mean the FDA is an
enforcement agency.
They weren't, the argumentswere not put in a legalistic
manner.
So I got a legal firm out ofWashington, D.C.
that specializes in um inapprovals, and we prof helped
(13:30):
professionalize their legalarguments for why the FDA should
not regulate uh these cadavericislets in this way.
And we published many op-edswith University of Chicago, San
Francisco, Penn, Harvard, theDiabetes Research Institute.
And through those op-eds, wheniTolerance was looking for a
(13:52):
CEO, they reached out to mebecause I'd had the business
background both at IBLDX as wellas Abbott.
And so because diabetes andtransplant is not my core
competency.
While I was at Abbott, Ioversaw transplant, which was
one of the therapeutic areasthat I managed as I got more uh
promotions, but it's not from ascientific level, uh was not my
(14:13):
core competency.
But when they showed me thenonhuman primate data showing a
functional cure withoutimmunosuppression, by the way,
in these monkeys that was doneat Mass General, Harvard, I was
stunned.
I looked at this data, and eventhough it wasn't my core
competency, I know what aglucose tolerance test looks
like.
(14:33):
And you give glucose and thesugar goes up, and then the body
makes insulin and it goes down.
Right, right.
Well, they make these monkeysdiabetic, and then they do a GTT
on them.
And after the transplant, atthree months and at six months,
they could show that the GTT hadreturned to normal.
(14:55):
So I saw the data and said,wow, this is really fascinating,
but it's not, I'm not theexpert.
So I called Dr.
Camilla Ricordi, our chiefscientist, who I'd been working
with on these op-eds, and said,Would you look at this data?
Of course, I asked eyetolerance if it was okay to
share the data with mycolleague, and they said, sure.
And Camillo, Dr.
Recordy, saw it and said, ifyou have an opportunity to take
(15:19):
this role, you should, and ifyou do, I will help.
It was the first company thathe actually was willing to take
a real role.
Dr.
Ricordi is world-renowned inthe islet area, um, but has
never taken like a formal role.
He'll consult as being on anSAB and such.
So with his um with his kind ofacknowledgement that this that
(15:41):
these preclinical data werereally meaningful, together with
my own assessment, I said,okay, I would interview for it.
And I met the scientific team,our two uh scientific founders
are Dr.
Andres Garcia from GeorgiaTech, and Dr.
Haval Sherwan, formerly at theUniversity of Louisville, now at
(16:02):
Missouri.
These two researchers have beenworking in this area for 25
years.
Uh, they've been in love withthe problem of immunosuppression
rather than the solution.
And looking at the data andlooking at the team, there was
no way it could say no when theyoffered me the CEO role.
Because I cared about diabetesafter HIV AIDS.
(16:22):
It's uh one of the mostimportant uh diseases of our
time.
It's a 24-7 disease.
And having um the opportunityto make an impact in yet another
disease that was so importantwas something I couldn't turn
down.
Ben Comer (16:37):
Um maybe you could uh just explain um why uh the lat
not using immunosuppressants isso important for patients, uh
whether it's you know a celltherapy or tissue or an organ
transplant or or a cure for type1 diabetes, why is it so
critical to be able to designsomething that will not require
(16:59):
chronic use ofimmunosuppressants?
Anthony Japour (17:02):
So everything is about risk-benefit, right?
So if you need a heart, lung,kidney, liver transplant, you
can't live without those organs,right?
So you're gonna take thatorgan, you'll take the
immunosuppression because, well,you can't live without them.
Diabetes, the analysis isdifferent.
You can have insulin.
There are insulin pumps.
That the technology in diabetesis a major with the CGMs, with
(17:25):
the pumps.
So, okay, well, now you're notgonna have to take insulin
anymore, but now you're gonna belike an immunosuppressed
patient for the rest of yourlife with all the bacterial,
viral, fungal infections, therisks for cancer.
I don't think most people woulddo it.
And they and and and theydon't.
They do uh they may, we don'tknow.
(17:46):
I mean, well, we know from thefirst product that that came out
that no, they haven't.
But with the product thatVertex is working on, which is
the cell therapy, which islooking very good, they're in
phase three now.
They probably will have FDAapproval within the next, I
think, year, maybe 18 months,and we'll see, because that's
(18:08):
with full immunosuppression.
But it's a huge leap to be ableto go from caveric eyelets to
stem cells.
So I really laud all theefforts that Vertex has been
doing and pioneering the SEMA,uh, which is the company they
bought.
So they're leading the way, butas a commercial opportunity, I
don't know how many patients aregoing to take something that
(18:29):
requires full immunosuppression.
And that's sort of why I joinedeyeTolerance, because I saw the
risk benefit that if you couldtake away the immunosuppression,
this is a billion-dollarcompany for sure.
Ben Comer (18:41):
Yeah.
Um uh cadaveric islets.
Um, is that what you're am Isaying that correctly?
These are like from oh,cadaveric, not as in cadaver.
Yes, it is from cadaver.
Fadaver as the root.
So these are extracted, Iguess, from a dead body, uh, but
the islet cells stay alive.
Do they multiply?
Anthony Japour (19:02):
No, they don't multiply.
They just basically uh theytake the whole pancreas, and
actually there's this thingcalled the Ricordi chamber,
which Dr.
Ricordi, our chief scientist,invented, where they put the
whole pancreas in this littleglass thing and they shake it up
or something, and somehow theeyelets fall up, they isolate
the eyelets from the pancreas,and then they they put it in,
(19:24):
they clean it, they put it inthe but it doesn't grow, and
then they do an infusion throughthe portal in the portal vein.
Uh a radiologist uh puts aneedle in the portal vein and
infuses that material into theliver, and then the liver
becomes both a liver as well asa pancreas.
Ben Comer (19:41):
Right.
They they don't infuse it tothe pancreas, it's actually put
onto the liver.
Yeah.
And that is still not availablein the U.S., but is available
widely.
Anthony Japour (19:49):
It's available under IND.
Okay.
And it's also available asLantidra.
So the University of Illinoisat Chicago, UIC, the uh
researcher there went to the FDAto work out, because it's all
about CMC at the end of the day,work out the CMC.
And they got FDA approval forLantidra, which is a cadaveric
(20:12):
islet transplant, um, but onlyat that one center.
One of the things that we weretrying to do with the
transplants uh group was try toget to the FDA to change the
regulatory framework forcadaveric eyelets.
And in fact, on uh January 6,2021, we were all on a um Zoom
(20:32):
with Peter Marks, Dr.
Peter Marks, who's head ofSEBR, trying to convince him
that these are not drugs,they're microorgans.
But he said our hands are tiedbecause it's in the federal
register, it's part of the CFR,that this is considered more
than minimally manipulated, andtherefore we have to regulate it
(20:52):
as drugs.
Ben Comer (20:53):
And if those islets are infused uh uh to the to the
liver, um that does requireimmunosuppression then.
Anthony Japour (21:01):
100% because it's from a from another person.
Ben Comer (21:03):
Right, right.
That's what that makes sense.
I was gonna I had this questionon my list of you know, when
are we gonna actually get to atype one, you know, a cure for
type one?
Because it seems like I don'tknow if you saw the movie, the
documentary, the human trial,which was pretty devastating.
Anthony Japour (21:18):
Um the one with the the one that uh Viceight
did?
Yes.
Oh yes, I did.
Yeah.
Oh yeah.
It was it was uh yeah.
Ben Comer (21:26):
And it it just because it seems like every
couple of years there's someexcitement, and it's like we
might actually, whether it's youknow, a kind of external
pancreas, which I I think is,you know, not a waste of time,
but it is not gonna be aseffective, obviously, as
something that you can putinside the body to cure the
disease.
But do you do you have a senseof that?
(21:47):
Do you, you know, is it is itsomething that's gonna happen
um, you know, in the next coupleof years or like in the next
decade?
What what do you think?
Anthony Japour (21:56):
Without I think I think the whole area of
regenerative medicine isbooming.
I think what Vertex is doingwith stem cells is really
leading the way.
Uh this is I mean, okay, so itstill requires immune
suppression, but it is a huge,huge leap.
So now we're getting into geneediting where we're starting to
(22:16):
take out the MHC components.
Unfortunately, I don't care howmany MHC components you take,
major, they're still going to beminor.
So there's always going to be arole in my mind for ITOL 100,
which is our product, whichcombines a stem cell therapy,
which is off the shelf, does notrequire using cadaver, so it's
like unlimited cell supply,together with an immune
(22:38):
modulator in a single productthat then can be placed in the
body, and the patient can haveboth the cell therapy and not
need to take theimmunosuppression.
So whether it's cadavericislets or stem cell derived,
like the VXA80 that Vertex has,or even a gene-edited product,
(23:00):
all of those products willstill, in my mind, based on my
understanding of the literature,will still require the I-Toll
100 to be completely successful.
Ben Comer (23:10):
Um that's really interesting.
Um could you would you mindjust giving me an overview?
Um you you've mentioned uh youknow, that particular um product
that you're developing, you'rein the preclinical stages.
Um, could you give uh theaudience a sense of the other
programs that you're working on?
Anthony Japour (23:27):
Right.
So our product works, as weknow now, with organoids, not
with whole organs, right?
But the idea that we have isthat if we use a nanoparticle
version of the I-TOL 100 andinject it in the sentinel lymph
(23:48):
nodes around the organ, uh, itmay be possible to actually do
large organ transplants, whichwould be right, incredible.
Yeah.
Um the preclinical studies havenot been done yet.
Um we're working with Dr.
Jim Markman, formerly, he wasthe one who did the NHP studies
at Harvard.
(24:08):
He's now at Penn.
And we're working with his teamto do a heterotopic transplant
looking at an animal model ofinjecting the sentinel nodes
around the organ with like uh akidney or liver, just to a proof
of concept.
So that's very early.
The other program we have iswith liver.
And the idea there is that wewould take liver cells that
(24:34):
actually do multiply, combine itwith our ITOL 100, and implant
it in the body.
So it could be like anexogenous liver transplant as
well.
The other area that this couldalso work in is really in rare
diseases, really in any cellthat makes a protein that's
missing.
So a lot of rare diseases, theprotein is either missing or
(24:56):
abnormal.
We could take a stem cell,engineer it to make a certain
kind of protein, like insulin,but it's a different protein,
put it into the body, and thenit starts to produce, and you
don't need to takeimmunosuppression.
We're only limited by money.
You know, we are a startup,we've raised a total of 27
million so far.
We've had 2 million innon-dilutive funding with both
(25:18):
uh grants from the um formerlyknown as Juvenile Diabetes
Research Foundation, J E R F nowknows break.
So we have an IDDP grant withthem, which has been amazing.
And then we also have a grantfrom the Binational Israeli USA
Research and Development Fund.
So we have about 2 million innon-dilutive, and we've raised
(25:38):
about 27 million total in thefour years.
So, you know, it's there's onlyso many things you can do.
So we're staying really laserfocused on diabetes, but I think
that this technology has a lotof other uses that you know
could be very important.
Ben Comer (25:55):
Um you're a privately held company.
Um, what uh how far away wouldyou say you are from human
clinical trials and what is yourkind of fundraising plan at
that point?
Or maybe give me a sense ofwhat your current runway is if
you're gonna be able to conductphase one with you know the 27
million that you've alreadyraised.
(26:15):
Um where where are you and whatare your plans in that regard?
Anthony Japour (26:20):
So as you know, drug development is not a
straight line.
Right.
No.
Okay, there are lots of pivotsand a lot of detours.
Um so, for example, in doingour CMC, our initial plan would
have gotten us in the clinic inthe in six months.
But that CMC plan didn't work.
And so we had to go to plan B,which took us 18 months to get
(26:43):
to a certain point.
So I'm always hesitant ingiving like timelines because
uh, you know, no sooner do you gsay, oh, we will file, you
know, on this date thansomething completely unexpected
happens.
But having said that, I wouldhope that we would be ready if
we go forward with our currentplan, which is our I-TOL 101,
(27:04):
which is the cadaveric eyelets,plus the I-TO 100, which seems
to be, at least at this moment,the fastest way to get into the
clinic.
We would be about a year fromuh uh filing the IND.
Um having said that, you know,there can be CMC issues that pop
up, there are funding issuesthat could pop up, preclinical,
which we've been, you know, FDAhas now taken away uh, or
(27:28):
they're trying to get rid of alot of the preclinical animal
study, the tox studies, becausethey don't we have faced, we
have faced this ourselves.
You know, these mice and rats,they're not really humans, but
it's like checking a box.
You have to have, you know,animal tox in two species, GLP.
They're very expensive.
Very expensive.
(27:48):
And uh so we have, you know, wewe've we've gotten over the
that leap, but like I say, everytime you pick a timeline,
there's always unexpected timeand costs.
Ben Comer (27:58):
Um our listeners, uh business of biotech are largely
made up of um uh ambitiouspeople building companies uh,
you know, from the earliest ofstages.
And so uh if you don't mind, Iwould love to ask, you know,
what what happened with theinitial CMC uh because you know,
it was a six-month process.
(28:20):
There was a something wentwrong, it took 18 months, you
know, to um to get to one thatworked.
Uh and I'm just thinking, youknow, if maybe there's something
you could say there that couldhelp others potentially avoid
doing something like that.
Maybe it was unavoidable.
I don't know.
Anthony Japour (28:38):
So um, and I also want to answer your
question before we go aboutrecruiting to Florida, because I
never answered that questionway back.
Um most therapeutic proteinsare made um through bacterial uh
uh vectors, like either oak E.
coli or Pseudomonas.
Um that's the fastest waybecause it's a cassette.
(28:58):
You just put your gene in, it'sdone.
It didn't work.
It killed the the the uh the uhthe strepavinin facel protein.
So there's two aspects of ourtechnology.
One is the biotinylatedmicrogel, so it's a microgel
that has biotin on its surface,and then we have a strepavidin
(29:20):
facel protein, and thestrepavidin binds to the a
biotin, and that's how we getthe configuration of the ITOL
100.
Okay.
So this protein side has to gothrough a vector to be produced.
Most therapeutic proteins areeither bacterial or chow cells,
right?
Fungal.
Chinese hamster or uh ovaries.
(29:42):
Yes, Chinese hamster ovary,yeah.
So we we tried the fastest way,because we you know we wanted
to be in the clinic as soon aspossible, was to go through E.
coli, didn't work.
Then we went into Chow cells.
Chow cells didn't work.
Oh no.
So we had to go back to whatthe researchers did way, way
(30:04):
back when using Drosophila S2.
So we had we had no researchcell bank.
We had to start from the TrevorBurrus.
Ben Comer (30:11):
But you wouldn't have known that if you hadn't tried
first and seen that it didn'twork.
Right, of course, right?
Anthony Japour (30:16):
Because you know, there in fact there were
only two companies that we couldfind in the world that actually
did develop well, actually, no,one company that did
development work with insectcells, because insects as a
vector are not commonly used astherapeutic proteins.
Now, we knew that the uh the itwas a complex protein with
glycosylation, but um it was notexpected until we went through
(30:42):
it.
And it put us behind sixmonths, but the timeline for
Drosophila takes 18 months.
Got it.
Ben Comer (30:50):
Okay.
Um I uh I have a final questionfor you.
Uh this is one that um I'vebeen asking to everyone that
I've been interviewing here inin South Florida, um, which is,
and it's a hypothetical.
Uh we're two for two so far onthis one.
Um I'll tell you two what thefirst two the two that answered
(31:13):
were, but uh this is not animportant question, but we'll
see what you say.
Let's assume you find yourselfin the predicted path of a
category four or category fivehurricane.
Do you board everything up andhunker down?
Or do you pack up the car andget out of Dodge?
Anthony Japour (31:30):
You mean personally or personally?
Ben Comer (31:32):
Personally.
Oh, okay.
So not your business I'm notgonna ask you to keep your
employees.
Anthony Japour (31:36):
No, I was gonna say it doesn't affect the
business because ourmanufacturing's done in
Lithuania.
So it doesn't affect our CDMO.
Right.
Uh and even if with the war inUkraine, which is, you know, uh,
we they also, Northway Biotech,which is our CDMO, has a whole
manufacturing site in Boston.
So we're we're covered um forthat.
(31:56):
Personally, um in the past, Istayed.
All right, three for three.
Wait, no, I've lived here 20years.
Now I'm packing up and going.
Yeah, because the storms aregetting worse, you think?
Bigger?
No, um, I just had a real PTSDafter the last one.
I lost everything in the lastmonth.
Like my entire apartment wascompletely destroyed um with not
(32:20):
a kitchen fixture or a bathroomfixture left, down to the
studs.
Unbelievable.
Yeah, and you were in there.
No, I wasn't in there.
It was at my mother's place,also half of her place had to be
taken out.
So I um yeah, I used to stay,but I wouldn't anymore.
Yeah, I don't blame you.
Yeah.
Okay.
Yeah.
All right.
Well, um So maybe it's two outof three.
Ben Comer (32:42):
Two out of three, yeah.
Yeah, two out of three.
We got one more, so we'll we'llsee what happens.
But um, Anthony, it's been areally a pleasure talking with
you.
Yes, thank you.
Anthony Japour (32:50):
Appreciate you coming on.
That was great.
It was and the lunch was alsothe discussion there was
incredible.
So thank you for coming andappreciate it.
Ben Comer (32:58):
Absolutely.
Uh, we've been speaking withAnthony Japoor, MD, CEO at
iTolerance.
I'm Ben Comer, and you've justlistened to the Business of
Biotech.
Find us and subscribe anywhereyou listen to podcasts, and be
sure to check out new weeklyvideo casts of these
conversations every Monday underthe Business of Biotech tab at
life science leader.com.
(33:19):
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 we're in Miami,Florida, for a series of
episodes recorded on location atthe offices of Catalyst
Pharmaceuticals.
For this series, we're speakingwith individuals operating
companies regionally here in theSunshine State, and I'm happy
(00:27):
to welcome Anthony Japour, MD,CEO at iTolerance, a preclinical
regenerative medicine and celltherapy company focused on type
1 diabetes, liver disease, andlarge organ transplant.
Anthony has worked at BigPharma, at a big CRO, and in
diagnostics and in consulting.
(00:48):
He received an MD fromNorthwestern and did postdoc
work in infectious diseases atHarvard.
I'm excited to hear aboutAnthony's work at iTolerance and
the company's quest to delivertissue organoid and cell
therapies to patients withoutthe need for ongoing
immunosuppression, not tomention a potential cure for
(01:10):
type 1 diabetes.
We'll also talk about thebenefits and drawbacks of
leading a biotech in SouthFlorida, what's happening in
regenerative medicine, andwhat's next for iTolerance.
Thanks for being here, Anthony.
Thanks for having me, Ben.
I wanted to start off as we doon the business of biotech with
your background.
And we'll take it way back.
(01:32):
How did you get interested inlife sciences initially?
And why did you want to turnthat interest into a career in
medicine?
Anthony Japour (01:43):
Well, ever since I was four years old, I wanted
to be a doctor.
Really?
My parents were like, we have avery strange child.
I was walking around with thedoctor's bag.
So I've always wanted to be anMD.
My parents were 100% againstit.
They didn't have, well, myparents are both deaf, and they
tried to cure my mother of herdeafness through a lot of odd
(02:05):
things.
And so she just didn't have agreat appreciation for doctors.
So here she has a child whosays, I want to be a doctor.
And um, so I had a choicegrowing up.
I could be either a lawyer, anaccountant, or a dentist.
Those are my three options.
A dentist, but not a doctor.
Right.
Well, I had a greatrelationship with my dentist,
(02:25):
and my mother's like, Why don'tyou be a dentist?
It's a better lifestyle.
Doctors work too much.
Her OBGYN and our pediatricianwere brothers and they worked
from morning to night.
So she didn't really think thatthe medicine profession had a
good lifestyle.
So anyway, I was a veryobedient child, and it wasn't
really until I got to Harvardthe first time in dental school
(02:47):
after college that I realizedthat I was on the wrong path.
And I took off and had to dothe MCATs all over again because
I had done the dental boardsbefore, uh, and then got into
Northwestern and finished mydegree there.
Ben Comer (03:02):
Um that's a that's a great story.
You actually did pursuedentistry before uh moving over
into uh And there's a lot oftremendous technological
advances in dentistry.
Anthony Japour (03:12):
It's an amazing field.
It just wasn't for me.
I knew I was on the wrong path.
Ben Comer (03:17):
I I will just say one problem I have with dentistry
is uh I feel like for the lastat least 25 years, no, my whole
life, the things that they takeuh the uh the x-rays with that
you have to open and bite downon hurt my gums so much.
They're so uncomfortable havingme too.
Where's the innovation in thein that technology?
I'm with you.
(03:37):
I those are hard, it's sopainful.
I just can't believe that theyhaven't been improved.
That it hasn't been fixed rightnow.
It has to be a giant metalblock that goes in your mouth.
Uh I wanted to ask, you were amedical director at Icon,
correct?
Yes.
Um what did you learn about uhhow clinical development works
(03:59):
that maybe people who have neverworked at a CRO or a CDMO, you
know, might that they just mightnot know or might not
understand?
Anthony Japour (04:08):
It was a fascinating experience being
there, I must say.
I never thought I would work ata CRO.
But I was offered theopportunity.
I was here in Florida, and forme to go back into farm or
biotech meant moving either backto Chicago or to the Northeast,
which I didn't want to do.
So I was doing other thingsdown here, but when I got the
opportunity to take a remoteposition with icon, I said, oh,
(04:32):
why not?
Fascinating opportunity.
Why?
For me, I got to work in somany therapeutic indications.
I worked in C diff.
Um, I worked with the seriesproduct, the first product for
C.
diff colitis, the uh uh uh thefecal transplant.
Ben Comer (04:48):
The fecal transplant, wow, okay.
Anthony Japour (04:50):
So that was one fantastic experience I had.
I got to work with them withtheir product when it failed
phase one, looked at all thedata to figure out where the
error error was and how whatdiagnostics they should change
it to for the phase two, and itended up being approved based on
my recommendations to thecompany.
So that was just one standoutexperience.
(05:12):
And you know, being a molecularvirologist by training, you
really understand all the basicsof science.
So whether it's cardiology orinfectious disease, which is my
core competency, or even um HepC Nash, I got to work in Nash.
So that was really great.
What I learned about thebusiness of CRO versus pharma is
(05:38):
they don't have patents, theydon't have intellectual
property.
So their revenue model ispurely service.
Right.
And that puts them at adisadvantage because they want
to be paid for their time.
There's just nothing free at aCRO.
You pay, it's like a la cartemenu.
Uh, but um, it was a greatexperience.
I learned a lot, and I thinkI've made a big difference while
(06:02):
I was there.
Ben Comer (06:03):
Um speaking of infectious diseases, you had
another CEO role before becomingCEO of eye tolerance in 2021
during, or no, I think it was in2020 during COVID.
Uh you worked as CEO atAdvanced DX Um Biological
Laboratories, which I believewas a COVID molecular diagnostic
(06:24):
uh maker based in Europe.
Perhaps could you uh tell us alittle bit about what that
experience is was, you know, waslike uh working for a COVID
diagnostic company, you know,right at the at the very
pinnacle of COVID at that time.
Anthony Japour (06:41):
So my core competency, as I mentioned, is
molecular virology, right?
So that's what I did at Harvardin HIV.
I worked on the first uh essaysfor HIV drug resistance, HIV
RNA essays.
So that was going all the wayback to like the 80s and 90s.
So here I am at ICON being amedical director, and I got
(07:02):
offered this position to leaveto become CEO of a diagnostic
company that's working of thedisease of our time.
So there was no way I couldn'tleave ICON to take this role.
It was very interesting.
Um, the science, this was acompany that was already rooted
in uh virologic diagnostics, uh,but not in COVID.
(07:24):
They were working in HIV andspecifically HIV drug
resistance, which again was mycore competency.
My role was purely commercial.
All of the regulatory and thescientific work was coming out
of Europe.
And that was when we had theEUA, emergency use
authorization.
Um so the nice thing about, Iguess, my life in this field is
(07:47):
my relationships with mycolleagues.
So I had to put together acommercial team literally in a
month.
And because I had such greatrelationships with people, in
this case Roche, I just calledup my old colleagues and said,
How would you like to come?
I need sales marketing now.
And they had remembered me from20 years ago and they're like,
(08:08):
Are you kidding?
Yes.
And to work on COVID, yes.
So I was able to put together acommercial team very quickly.
Uh the frustrating part for mewas I had no part in the
regulatory side of it.
And my colleagues at AdvancedDX, um, which was based out of
Europe, didn't understand thatwhen you tell the FDA that
(08:31):
you're gonna give them data in10 days, and you don't give them
data in 10 days because you'redoing something else, they're
gonna put you at the bottom ofthe pile, which is exactly what
happened.
So we built out the commercialorganization.
I had contracts ready to go,just waiting for the EUA
approval.
But because EUA approval didn'thappen in a timely fashion, we
(08:55):
were not able to, we weren'table to market and sell in the
US.
Ben Comer (09:00):
Oh, that's too bad.
Um is there anything uh thatthat you remember, uh, just you
know, had a bird's eye view ofCOVID at the worst time of it
before a vaccine was available,I think, right?
Um and you were, you know,dealing with Europe, leading a
European company, um, you know,living in the US, were were
(09:21):
there differences that stuck outto you in terms of how people
were, I don't know, reacting toCOVID, adopting, you know,
diagnostics and therapeutics,anything that struck you as uh,
you know, a kind of black andwhite difference between Europe
and the US during that earlytime of COVID when, you know, it
was uh it was scary foreverybody.
Anthony Japour (09:44):
What's interesting is all of our
products were approved inEurope.
And we couldn't get themapproved in the US.
Yeah.
In part because of thebureaucracy.
Um and um, you know, so andthat was also the era of LDT,
laboratory diagnostic testing,where each lab could come up
(10:04):
with their own, which wascomplicating things.
What was good about it is Ifelt like I was making a
contribution in the infectiousdisease important issue of the
day that if I had stayed atICON, I would have felt bad that
I didn't get involved, sort oflike getting into the military.
I felt like I signed up.
But um Europe had a much morerelaxed way of getting the EUAs
(10:30):
for those diagnostic tests thanthe US did.
US was quite challenging.
Um, we also had both antibodytests as well as the PCR-based
tests.
And I just remember there was alot of frustration with
actually even getting productinto the US, like they held it
up at customs.
Uh so there was, but you know,we kind of rallied through and
(10:54):
uh we felt like we were making acontribution in some way, even
though we ultimately were notsuccessful.
Ben Comer (11:01):
Um let's talk about iTolerance.
Uh over lunch, you know, we wehad lunch together, uh, Anthony.
It's a big, big reveal for thethe podcast.
I'm down in uh South Florida,and what you know, we we all got
together.
But uh you mentioned that youwere the first employee at
iTolerance uh and that you hadtrouble recruiting for certain
(11:22):
positions, uh, you know,bringing people into South
Florida.
I wonder if you could um talk alittle bit about that.
Anthony Japour (11:29):
Sure.
Uh so after ABLDX, I was in norush to jump into another
position.
Um, in fact, it was about ninemonths between my two roles.
But one of the nice things ofhaving all this gray hair is you
don't have to jump from onething to the next, that you can
really wait.
And I think that was part ofthe discussion that we had, that
(11:50):
there's a tremendous pool oftalent here in Florida, of
people with a lot of experience,but they don't have to take a
job.
They're happy with what they'redoing.
And that's sort of where Ifound myself.
So when so I I had been doingum uh pro bono work with the
Diabetes Research Institute herein Miami because the FDA
regulates uh cadaveric donorislets as drugs as opposed to
(12:17):
donated organs, which theAmerican taxpayers paid over $20
million for the phase threestudy showing that cadaveric
islets can cure type 1 diabetes.
And it's approved in the entireworld and and compensated,
including China and Iran, butnot in the U.S.
Ben Comer (12:35):
And it's working as a functional cure for type one?
Yes.
It is a functional cure.
Why are we not hearing aboutthat here in the US?
Anthony Japour (12:42):
Well, so so I was so so I, you know, very
close to the people in theDiabetes Research Institute.
And when I had this period oftime when I was kind of free, if
you will, after ABLDX, I said,is there anything I can do to
help?
And they were showing me theregulatory communications
between all the transplantcenters in the country and in
(13:06):
the FDA.
And I realized that they wereapproaching it as academics,
physicians, surgeons who wantedto cure patients, but they
weren't approaching it from alegal, I mean the FDA is an
enforcement agency.
They weren't, the argumentswere not put in a legalistic
manner.
So I got a legal firm out ofWashington, D.C.
that specializes in um inapprovals, and we prof helped
(13:30):
professionalize their legalarguments for why the FDA should
not regulate uh these cadavericislets in this way.
And we published many op-edswith University of Chicago, San
Francisco, Penn, Harvard, theDiabetes Research Institute.
And through those op-eds, wheniTolerance was looking for a
(13:52):
CEO, they reached out to mebecause I'd had the business
background both at IBLDX as wellas Abbott.
And so because diabetes andtransplant is not my core
competency.
While I was at Abbott, Ioversaw transplant, which was
one of the therapeutic areasthat I managed as I got more uh
promotions, but it's not from ascientific level, uh was not my
(14:13):
core competency.
But when they showed me thenonhuman primate data showing a
functional cure withoutimmunosuppression, by the way,
in these monkeys that was doneat Mass General, Harvard, I was
stunned.
I looked at this data, and eventhough it wasn't my core
competency, I know what aglucose tolerance test looks
like.
(14:33):
And you give glucose and thesugar goes up, and then the body
makes insulin and it goes down.
Right, right.
Well, they make these monkeysdiabetic, and then they do a GTT
on them.
And after the transplant, atthree months and at six months,
they could show that the GTT hadreturned to normal.
(14:55):
So I saw the data and said,wow, this is really fascinating,
but it's not, I'm not theexpert.
So I called Dr.
Camilla Ricordi, our chiefscientist, who I'd been working
with on these op-eds, and said,Would you look at this data?
Of course, I asked eyetolerance if it was okay to
share the data with mycolleague, and they said, sure.
And Camillo, Dr.
Recordy, saw it and said, ifyou have an opportunity to take
(15:19):
this role, you should, and ifyou do, I will help.
It was the first company thathe actually was willing to take
a real role.
Dr.
Ricordi is world-renowned inthe islet area, um, but has
never taken like a formal role.
He'll consult as being on anSAB and such.
So with his um with his kind ofacknowledgement that this that
(15:41):
these preclinical data werereally meaningful, together with
my own assessment, I said,okay, I would interview for it.
And I met the scientific team,our two uh scientific founders
are Dr.
Andres Garcia from GeorgiaTech, and Dr.
Haval Sherwan, formerly at theUniversity of Louisville, now at
(16:02):
Missouri.
These two researchers have beenworking in this area for 25
years.
Uh, they've been in love withthe problem of immunosuppression
rather than the solution.
And looking at the data andlooking at the team, there was
no way it could say no when theyoffered me the CEO role.
Because I cared about diabetesafter HIV AIDS.
(16:22):
It's uh one of the mostimportant uh diseases of our
time.
It's a 24-7 disease.
And having um the opportunityto make an impact in yet another
disease that was so importantwas something I couldn't turn
down.
Ben Comer (16:37):
Um maybe you could uh just explain um why uh the lat
not using immunosuppressants isso important for patients, uh
whether it's you know a celltherapy or tissue or an organ
transplant or or a cure for type1 diabetes, why is it so
critical to be able to designsomething that will not require
(16:59):
chronic use ofimmunosuppressants?
Anthony Japour (17:02):
So everything is about risk-benefit, right?
So if you need a heart, lung,kidney, liver transplant, you
can't live without those organs,right?
So you're gonna take thatorgan, you'll take the
immunosuppression because, well,you can't live without them.
Diabetes, the analysis isdifferent.
You can have insulin.
There are insulin pumps.
That the technology in diabetesis a major with the CGMs, with
(17:25):
the pumps.
So, okay, well, now you're notgonna have to take insulin
anymore, but now you're gonna belike an immunosuppressed
patient for the rest of yourlife with all the bacterial,
viral, fungal infections, therisks for cancer.
I don't think most people woulddo it.
And they and and and theydon't.
They do uh they may, we don'tknow.
(17:46):
I mean, well, we know from thefirst product that that came out
that no, they haven't.
But with the product thatVertex is working on, which is
the cell therapy, which islooking very good, they're in
phase three now.
They probably will have FDAapproval within the next, I
think, year, maybe 18 months,and we'll see, because that's
(18:08):
with full immunosuppression.
But it's a huge leap to be ableto go from caveric eyelets to
stem cells.
So I really laud all theefforts that Vertex has been
doing and pioneering the SEMA,uh, which is the company they
bought.
So they're leading the way, butas a commercial opportunity, I
don't know how many patients aregoing to take something that
(18:29):
requires full immunosuppression.
And that's sort of why I joinedeyeTolerance, because I saw the
risk benefit that if you couldtake away the immunosuppression,
this is a billion-dollarcompany for sure.
Ben Comer (18:41):
Yeah.
Um uh cadaveric islets.
Um, is that what you're am Isaying that correctly?
These are like from oh,cadaveric, not as in cadaver.
Yes, it is from cadaver.
Fadaver as the root.
So these are extracted, Iguess, from a dead body, uh, but
the islet cells stay alive.
Do they multiply?
Anthony Japour (19:02):
No, they don't multiply.
They just basically uh theytake the whole pancreas, and
actually there's this thingcalled the Ricordi chamber,
which Dr.
Ricordi, our chief scientist,invented, where they put the
whole pancreas in this littleglass thing and they shake it up
or something, and somehow theeyelets fall up, they isolate
the eyelets from the pancreas,and then they they put it in,
(19:24):
they clean it, they put it inthe but it doesn't grow, and
then they do an infusion throughthe portal in the portal vein.
Uh a radiologist uh puts aneedle in the portal vein and
infuses that material into theliver, and then the liver
becomes both a liver as well asa pancreas.
Ben Comer (19:41):
Right.
They they don't infuse it tothe pancreas, it's actually put
onto the liver.
Yeah.
And that is still not availablein the U.S., but is available
widely.
Anthony Japour (19:49):
It's available under IND.
Okay.
And it's also available asLantidra.
So the University of Illinoisat Chicago, UIC, the uh
researcher there went to the FDAto work out, because it's all
about CMC at the end of the day,work out the CMC.
And they got FDA approval forLantidra, which is a cadaveric
(20:12):
islet transplant, um, but onlyat that one center.
One of the things that we weretrying to do with the
transplants uh group was try toget to the FDA to change the
regulatory framework forcadaveric eyelets.
And in fact, on uh January 6,2021, we were all on a um Zoom
(20:32):
with Peter Marks, Dr.
Peter Marks, who's head ofSEBR, trying to convince him
that these are not drugs,they're microorgans.
But he said our hands are tiedbecause it's in the federal
register, it's part of the CFR,that this is considered more
than minimally manipulated, andtherefore we have to regulate it
(20:52):
as drugs.
Ben Comer (20:53):
And if those islets are infused uh uh to the to the
liver, um that does requireimmunosuppression then.
Anthony Japour (21:01):
100% because it's from a from another person.
Ben Comer (21:03):
Right, right.
That's what that makes sense.
I was gonna I had this questionon my list of you know, when
are we gonna actually get to atype one, you know, a cure for
type one?
Because it seems like I don'tknow if you saw the movie, the
documentary, the human trial,which was pretty devastating.
Anthony Japour (21:18):
Um the one with the the one that uh Viceight
did?
Yes.
Oh yes, I did.
Yeah.
Oh yeah.
It was it was uh yeah.
Ben Comer (21:26):
And it it just because it seems like every
couple of years there's someexcitement, and it's like we
might actually, whether it's youknow, a kind of external
pancreas, which I I think is,you know, not a waste of time,
but it is not gonna be aseffective, obviously, as
something that you can putinside the body to cure the
disease.
But do you do you have a senseof that?
(21:47):
Do you, you know, is it is itsomething that's gonna happen
um, you know, in the next coupleof years or like in the next
decade?
What what do you think?
Anthony Japour (21:56):
Without I think I think the whole area of
regenerative medicine isbooming.
I think what Vertex is doingwith stem cells is really
leading the way.
Uh this is I mean, okay, so itstill requires immune
suppression, but it is a huge,huge leap.
So now we're getting into geneediting where we're starting to
(22:16):
take out the MHC components.
Unfortunately, I don't care howmany MHC components you take,
major, they're still going to beminor.
So there's always going to be arole in my mind for ITOL 100,
which is our product, whichcombines a stem cell therapy,
which is off the shelf, does notrequire using cadaver, so it's
like unlimited cell supply,together with an immune
(22:38):
modulator in a single productthat then can be placed in the
body, and the patient can haveboth the cell therapy and not
need to take theimmunosuppression.
So whether it's cadavericislets or stem cell derived,
like the VXA80 that Vertex has,or even a gene-edited product,
(23:00):
all of those products willstill, in my mind, based on my
understanding of the literature,will still require the I-Toll
100 to be completely successful.
Ben Comer (23:10):
Um that's really interesting.
Um could you would you mindjust giving me an overview?
Um you you've mentioned uh youknow, that particular um product
that you're developing, you'rein the preclinical stages.
Um, could you give uh theaudience a sense of the other
programs that you're working on?
Anthony Japour (23:27):
Right.
So our product works, as weknow now, with organoids, not
with whole organs, right?
But the idea that we have isthat if we use a nanoparticle
version of the I-TOL 100 andinject it in the sentinel lymph
(23:48):
nodes around the organ, uh, itmay be possible to actually do
large organ transplants, whichwould be right, incredible.
Yeah.
Um the preclinical studies havenot been done yet.
Um we're working with Dr.
Jim Markman, formerly, he wasthe one who did the NHP studies
at Harvard.
(24:08):
He's now at Penn.
And we're working with his teamto do a heterotopic transplant
looking at an animal model ofinjecting the sentinel nodes
around the organ with like uh akidney or liver, just to a proof
of concept.
So that's very early.
The other program we have iswith liver.
And the idea there is that wewould take liver cells that
(24:34):
actually do multiply, combine itwith our ITOL 100, and implant
it in the body.
So it could be like anexogenous liver transplant as
well.
The other area that this couldalso work in is really in rare
diseases, really in any cellthat makes a protein that's
missing.
So a lot of rare diseases, theprotein is either missing or
(24:56):
abnormal.
We could take a stem cell,engineer it to make a certain
kind of protein, like insulin,but it's a different protein,
put it into the body, and thenit starts to produce, and you
don't need to takeimmunosuppression.
We're only limited by money.
You know, we are a startup,we've raised a total of 27
million so far.
We've had 2 million innon-dilutive funding with both
(25:18):
uh grants from the um formerlyknown as Juvenile Diabetes
Research Foundation, J E R F nowknows break.
So we have an IDDP grant withthem, which has been amazing.
And then we also have a grantfrom the Binational Israeli USA
Research and Development Fund.
So we have about 2 million innon-dilutive, and we've raised
(25:38):
about 27 million total in thefour years.
So, you know, it's there's onlyso many things you can do.
So we're staying really laserfocused on diabetes, but I think
that this technology has a lotof other uses that you know
could be very important.
Ben Comer (25:55):
Um you're a privately held company.
Um, what uh how far away wouldyou say you are from human
clinical trials and what is yourkind of fundraising plan at
that point?
Or maybe give me a sense ofwhat your current runway is if
you're gonna be able to conductphase one with you know the 27
million that you've alreadyraised.
(26:15):
Um where where are you and whatare your plans in that regard?
Anthony Japour (26:20):
So as you know, drug development is not a
straight line.
Right.
No.
Okay, there are lots of pivotsand a lot of detours.
Um so, for example, in doingour CMC, our initial plan would
have gotten us in the clinic inthe in six months.
But that CMC plan didn't work.
And so we had to go to plan B,which took us 18 months to get
(26:43):
to a certain point.
So I'm always hesitant ingiving like timelines because
uh, you know, no sooner do you gsay, oh, we will file, you
know, on this date thansomething completely unexpected
happens.
But having said that, I wouldhope that we would be ready if
we go forward with our currentplan, which is our I-TOL 101,
(27:04):
which is the cadaveric eyelets,plus the I-TO 100, which seems
to be, at least at this moment,the fastest way to get into the
clinic.
We would be about a year fromuh uh filing the IND.
Um having said that, you know,there can be CMC issues that pop
up, there are funding issuesthat could pop up, preclinical,
which we've been, you know, FDAhas now taken away uh, or
(27:28):
they're trying to get rid of alot of the preclinical animal
study, the tox studies, becausethey don't we have faced, we
have faced this ourselves.
You know, these mice and rats,they're not really humans, but
it's like checking a box.
You have to have, you know,animal tox in two species, GLP.
They're very expensive.
Very expensive.
(27:48):
And uh so we have, you know, wewe've we've gotten over the
that leap, but like I say, everytime you pick a timeline,
there's always unexpected timeand costs.
Ben Comer (27:58):
Um our listeners, uh business of biotech are largely
made up of um uh ambitiouspeople building companies uh,
you know, from the earliest ofstages.
And so uh if you don't mind, Iwould love to ask, you know,
what what happened with theinitial CMC uh because you know,
it was a six-month process.
(28:20):
There was a something wentwrong, it took 18 months, you
know, to um to get to one thatworked.
Uh and I'm just thinking, youknow, if maybe there's something
you could say there that couldhelp others potentially avoid
doing something like that.
Maybe it was unavoidable.
I don't know.
Anthony Japour (28:38):
So um, and I also want to answer your
question before we go aboutrecruiting to Florida, because I
never answered that questionway back.
Um most therapeutic proteinsare made um through bacterial uh
uh vectors, like either oak E.
coli or Pseudomonas.
Um that's the fastest waybecause it's a cassette.
(28:58):
You just put your gene in, it'sdone.
It didn't work.
It killed the the the uh the uhthe strepavinin facel protein.
So there's two aspects of ourtechnology.
One is the biotinylatedmicrogel, so it's a microgel
that has biotin on its surface,and then we have a strepavidin
(29:20):
facel protein, and thestrepavidin binds to the a
biotin, and that's how we getthe configuration of the ITOL
100.
Okay.
So this protein side has to gothrough a vector to be produced.
Most therapeutic proteins areeither bacterial or chow cells,
right?
Fungal.
Chinese hamster or uh ovaries.
(29:42):
Yes, Chinese hamster ovary,yeah.
So we we tried the fastest way,because we you know we wanted
to be in the clinic as soon aspossible, was to go through E.
coli, didn't work.
Then we went into Chow cells.
Chow cells didn't work.
Oh no.
So we had to go back to whatthe researchers did way, way
(30:04):
back when using Drosophila S2.
So we had we had no researchcell bank.
We had to start from the TrevorBurrus.
Ben Comer (30:11):
But you wouldn't have known that if you hadn't tried
first and seen that it didn'twork.
Right, of course, right?
Anthony Japour (30:16):
Because you know, there in fact there were
only two companies that we couldfind in the world that actually
did develop well, actually, no,one company that did
development work with insectcells, because insects as a
vector are not commonly used astherapeutic proteins.
Now, we knew that the uh the itwas a complex protein with
glycosylation, but um it was notexpected until we went through
(30:42):
it.
And it put us behind sixmonths, but the timeline for
Drosophila takes 18 months.
Got it.
Ben Comer (30:50):
Okay.
Um I uh I have a final questionfor you.
Uh this is one that um I'vebeen asking to everyone that
I've been interviewing here inin South Florida, um, which is,
and it's a hypothetical.
Uh we're two for two so far onthis one.
Um I'll tell you two what thefirst two the two that answered
(31:13):
were, but uh this is not animportant question, but we'll
see what you say.
Let's assume you find yourselfin the predicted path of a
category four or category fivehurricane.
Do you board everything up andhunker down?
Or do you pack up the car andget out of Dodge?
Anthony Japour (31:30):
You mean personally or personally?
Ben Comer (31:32):
Personally.
Oh, okay.
So not your business I'm notgonna ask you to keep your
employees.
Anthony Japour (31:36):
No, I was gonna say it doesn't affect the
business because ourmanufacturing's done in
Lithuania.
So it doesn't affect our CDMO.
Right.
Uh and even if with the war inUkraine, which is, you know, uh,
we they also, Northway Biotech,which is our CDMO, has a whole
manufacturing site in Boston.
So we're we're covered um forthat.
(31:56):
Personally, um in the past, Istayed.
All right, three for three.
Wait, no, I've lived here 20years.
Now I'm packing up and going.
Yeah, because the storms aregetting worse, you think?
Bigger?
No, um, I just had a real PTSDafter the last one.
I lost everything in the lastmonth.
Like my entire apartment wascompletely destroyed um with not
(32:20):
a kitchen fixture or a bathroomfixture left, down to the
studs.
Unbelievable.
Yeah, and you were in there.
No, I wasn't in there.
It was at my mother's place,also half of her place had to be
taken out.
So I um yeah, I used to stay,but I wouldn't anymore.
Yeah, I don't blame you.
Yeah.
Okay.
Yeah.
All right.
Well, um So maybe it's two outof three.
Ben Comer (32:42):
Two out of three, yeah.
Yeah, two out of three.
We got one more, so we'll we'llsee what happens.
But um, Anthony, it's been areally a pleasure talking with
you.
Yes, thank you.
Anthony Japour (32:50):
Appreciate you coming on.
That was great.
It was and the lunch was alsothe discussion there was
incredible.
So thank you for coming andappreciate it.
Ben Comer (32:58):
Absolutely.
Uh, we've been speaking withAnthony Japoor, MD, CEO at
iTolerance.
I'm Ben Comer, and you've justlistened to the Business of
Biotech.
Find us and subscribe anywhereyou listen to podcasts, and be
sure to check out new weeklyvideo casts of these
conversations every Monday underthe Business of Biotech tab at
life science leader.com.
(33:19):
We'll see you next week, andthanks as always for listening.
Popular Podcasts
Stuff You Should Know
If you've ever wanted to know about champagne, satanism, the Stonewall Uprising, chaos theory, LSD, El Nino, true crime and Rosa Parks, then look no further. Josh and Chuck have you covered.
Ruthie's Table 4
For more than 30 years The River Cafe in London, has been the home-from-home of artists, architects, designers, actors, collectors, writers, activists, and politicians. Michael Caine, Glenn Close, JJ Abrams, Steve McQueen, Victoria and David Beckham, and Lily Allen, are just some of the people who love to call The River Cafe home. On River Cafe Table 4, Rogers sits down with her customers—who have become friends—to talk about food memories. Table 4 explores how food impacts every aspect of our lives. “Foods is politics, food is cultural, food is how you express love, food is about your heritage, it defines who you and who you want to be,” says Rogers. Each week, Rogers invites her guest to reminisce about family suppers and first dates, what they cook, how they eat when performing, the restaurants they choose, and what food they seek when they need comfort. And to punctuate each episode of Table 4, guests such as Ralph Fiennes, Emily Blunt, and Alfonso Cuarón, read their favourite recipe from one of the best-selling River Cafe cookbooks. Table 4 itself, is situated near The River Cafe’s open kitchen, close to the bright pink wood-fired oven and next to the glossy yellow pass, where Ruthie oversees the restaurant. You are invited to take a seat at this intimate table and join the conversation. For more information, recipes, and ingredients, go to https://shoptherivercafe.co.uk/ Web: https://rivercafe.co.uk/ Instagram: www.instagram.com/therivercafelondon/ Facebook: https://en-gb.facebook.com/therivercafelondon/ For more podcasts from iHeartRadio, visit the iheartradio app, apple podcasts, or wherever you listen to your favorite shows. Learn more about your ad-choices at https://www.iheartpodcastnetwork.com
Dateline NBC
Current and classic episodes, featuring compelling true-crime mysteries, powerful documentaries and in-depth investigations. Follow now to get the latest episodes of Dateline NBC completely free, or subscribe to Dateline Premium for ad-free listening and exclusive bonus content: DatelinePremium.com