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On this week's episode, ex-handballer Vladimir Cmiljanovic, Ph.D., Founder and CEO at Swiss Rockets, talks about co-discovering bimiralisib with his sister Natasa Cmiljanovic, Ph.D. (and COO at Swiss Rockets), losing his company to a hostile takeover, buying the company back, and building out Swiss Rockets as an incubator with manufacturing capabilities and shared scientific expertise. Swiss Rockets' portfolio of companies is developing radioligand therapies, vaccines, and cancer treatments, including bimiralisib for actinic keratosis. Cmiljanovic also discusses U.S. expansion plans, partnering, and funding strategies for early-stage companies.
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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 pleased to speakwith Vladimir Cmiljanovic, an
award-winning scientist andfounder and CEO at Swiss Rockets
AG, a biotech incubator andaccelerator working across
several drug modalities andtherapeutic areas.
(00:27):
Vladimir is the co-discoverer,along with his sister, Natasha
Cmiljanovic, of bimiralisib,which is currently in
development for actinickeratosis or AK, which are
precancerous lesions in the skinthat often develop into skin
cancer.
I'm excited to talk to Vladabout the discovery of
(00:50):
bimiralicib, spinning out acompany to develop that drug,
the twists and turns andadditional company formation
work he's been involved withsince that discovery, how Swiss
Rockets the incubator works andwhat he's planning for the
future.
Thanks so much for being here,Vlad.
Thank works and what he'splanning for the future.
Thanks so much for being here,Vlad.
Vladimir Cmiljanovic, Ph. (01:08):
Thank you, ben, so much for inviting
me, and I'm very happy to betoday with you and people also
listening to this podcast.
Ben Comer (01:16):
Me too, and as we do on the business of biotech, Vlad
, I'd like to get to know you alittle bit how you got started
in this business, what yourmotivations are, what
circumstances led you into thefield of drug discovery
initially.
Vladimir Cmiljanovic, Ph (01:34):
That's a very good question.
So actually, when I was only afive-year-old boy only a five
years old boy um, I only said tomy mom one day I'm gonna find a
drug against cancer.
And probably I said that to herbecause of the love I had to my
(01:55):
mother of course, my father too, but my mother because my mom
lost her mom, my grandmotherwhen she was 12 years old on
leukemia.
So I never met my realgrandmother and, and due to that
love to my mom, I already atthat time I knew that actually
that's something I would like todo.
Many years later, I realizedthis is my mission on this earth
(02:19):
, looking for new anti-cancerdrugs, and I grew up up in
Serbia, in Eastern Europe, whereI was a professional team
handball player.
In Europe this is one of themost popular sports.
It's like rugby, but just on asmaller field, and I was playing
(02:39):
handball professionally andusing the money from
professional handball,reinvesting that money to my
education in chemistry, and in2003 I started to work within
university of basel inswitzerland, where I was living
and playing professionalhandball.
Later I started to work on anew class of enzymes, so-called
(03:07):
lipid kinases, and I startedactually to discover new
molecules and that was a bigsuccess.
We actually discovered somevery important enzymes called
mTOR and PI3K Kinesis in ourbody.
My professors discovered thosekinesis.
(03:29):
I was working with ProfessorMichael, who discovered TOR or
mTOR later, who is today in theboard of directors of our
company, swiss Rockets.
I was also working with peoplefrom Harvard Medical School,
professor Luke Huntley.
He discovered P3K-alpha.
He was director of HarvardMedical School and I was working
(03:54):
on the first generationmolecules called rapamycin
analogs, based on the discoveryof my professor Michael, and
then Leighton Nov novartis bigpharma company, also here based
in basel as a headquarter.
They started to collaboratewith university of basel and
(04:14):
they did the whole furtherdevelopment of a rapamycin
analog.
That has been, in 2010,registered for different solid
tumor cancers and the drug istoday known in the US and
worldwide as Afinitor orEverolimus.
That's how everything started.
We became very well known asscientists worldwide, also in
(04:37):
the industry, for thoseachievements.
But I knew at that time thatthis is just the beginning,
because I knew how much we donot know about those enzymes and
I had a very strong passion todiscover further things in that
area.
I invited my sister, natasha,to come from Serbia to
(04:59):
Switzerland as she studiedmedicine sorry, the chemistry,
medicinal chemistry in Serbia.
We started to work together inBasel and we discovered
molecules that can block mTORand its twin brother enzyme
called PR3K.
They have almost identicalstructure so they look like
twins and they have twodifferent, very important
(05:24):
functions.
Mtor is controlling the growthof cancer cells and PRTK is
controlling the metabolism ofcancer cells, actually the
production of sugar within thecancer cells.
So we wanted to discover a drugthat can block both enzymes at
the same time, stopping thegrowth of cancer cells on one
(05:45):
side and on another sidestopping the production of sugar
within the cancer cells.
No sugar, no energy, and youliterally starve the cancer
cells out.
That was the mechanism of actionthat we have proven very
successfully with the inhibitorcalled B-Miralizib.
B means dual PR3KM2 inhibitionand mira was the name of our
(06:08):
mother, so we put it her namethere to do something nice and
also to to on on her owner totry to have many patients as
possible.
So bimiralizib has beendeveloped so far in solid tumors
, in lymphomas, different typesof tumors, as an orally
(06:30):
bioavailable drug, but in formof the topical application,
meaning in form of a cream orgel of the same drug, we were
able to develop a product forskin cancer, and now we have new
results showing breakthroughscience of this drug in that
particular cancer type.
Ben Comer (06:51):
Yeah, and I want to ask you some follow-up on Ben
Morales' Sib in terms of whereit is in development, how you
landed on that AK target skincancer.
But I wonder if first you couldjust talk through
co-discovering that with yoursister.
I'm interested to hear yourthoughts about what that was
(07:13):
like, how it happened, what itmeant for both you and Natasha.
Vladimir Cmiljanovic, Ph. (07:19):
Thank you Also a very nice question.
So we actually wanted to learnmore about those enzymes in
general.
We knew that those enzymes playone of the most important roles
in cancer, but at that time,early 2000 and and later, so up
to the 2011, we wanted tounderstand what is really the
(07:44):
role of these two enzymes and westarted.
In about 2003, we started todiscover molecules that can
literally act as spy molecules,investigating about those
enzymes without that enzymesknow that they are labeled with
(08:06):
small molecules, but learningabout their function and about
their biology.
And this was actually my masterthesis developing molecules
which are going to help uslearning more about the biology
of those important enzymesimportant for cancer metabolism.
Ben Comer (08:27):
Know thine enemy right.
You had to get to know thosepathways to learn how to inhibit
them.
Is that right Exactly?
Vladimir Cmiljanovic, P (08:34):
exactly .
And then, having that research,step by step, we found out we
literally have very interestinginhibitors of those enzymes out.
We literally have veryinteresting inhibitors of those
enzymes.
So if you inhibit them you canstop certain functions and you
could have a direct benefit forcancer patients.
And when we realized that weactually have a new drug in our
(08:57):
hands, then nothing was there tostop us to go with the further
research and further developmentin direction anti-cancer drug
discovery.
And later we founded our owncompany and organized a lot of
investments, a lot of fundingand today we are at the late
(09:19):
stage of the clinicaldevelopment.
Ben Comer (09:21):
Right.
So you made this discovery, wasthere initial indication that
you had in mind, you know?
Did you initially think that itwould target solid tumors?
Did you already think that itcould be applicable in skin
cancer?
How did you think about that,how you would develop it?
You know, start the developmentwork, yes.
Vladimir Cmiljanovic, Ph.D. (09:39):
So first, we tested the drug in
many different cancer cells.
In those experiments we foundout that this drug actually has
a very unique mechanismExhausting the cancer cells,
could be applied theoreticallyin 200 out of 250 different
cancers.
And then for many cancers wetested that in vivo experiments
(10:04):
in animal models, in tumorxenograft models.
But then when we founded ourcompany, we needed to decide for
further development what arethe cancers that we want to
tackle?
We decided to test the drug innon-Hodgkin lymphomas, in
different solid tumors like headand neck cancer, breast cancer,
(10:24):
prostate cancer or glioblastoma, for example very aggressive
brain tumor, because we madethat drug also brain penetrant.
The drug has excellent brainpenetration properties and
therefore it could be alsoapplied to different brain
tumors.
So we tested that over theyears in clinical trials in the
(10:46):
US and in Europe and we realizedthe drug can work there.
But one of my scientists saidokay, it would be very
interesting if you could alsotry to test your drug in one of
the most common skin cancers andone of the most common tumours
(11:06):
at all, so-called non-melanomaskin cancer.
And why?
Because this non-melanoma skincancer has also activated P3K
mTOR pathway, probably more thanother tumours.
So what we did?
We started to test that first,also in animal models.
This was very successful.
We did that with Professor JohnSecora from University of
(11:31):
Pennsylvania and we realizedthat we are literally melting
the tumors of the myces.
We cured all of those myces andwe realized, wow, this is the
best result that we have so farin the career.
We literally, with a cream, weare melting the tumor that was
(11:55):
on the skin of those animalmodels.
All the animals were cured withthe drug.
And then we worked further toorganize the funding to test
also the same drug in humanpatients.
And now we have confirmed thatthe drug works excellent, with
breakthrough results in phase 2clinical trials.
(12:15):
What is the result?
Very shortly, we have shownthat in this disease called
actinic keratosis, which is aprecursor, pre-malignant disease
of non-melanoma skin cancer.
By the way, non-melanoma skincancer is the second most common
tumor among all the tumors, soit's a very frequent cancer
(12:37):
coming because of the UV lightradiation.
So the older we are, the moresensitive is our skin to the UV
light and people are gettingfirst actinic keratosis.
Ben Comer (12:54):
And these are some of the lesions that listeners will
know they've probably hadeither themselves or their
family members have gone in tohave these surgically removed.
Is that right?
Vladimir Cmiljanovic, Ph.D. (13:04):
Yes , family members have gone in to
have these surgically removed.
Is that right?
Yes, first, actually, people,the surgeons, the dermatologists
or dermatologists they aredoing the surgical removal of
those lesions by some people.
The lesions are coming back, soas a surgeon, you can take one
or two lesions more.
(13:24):
The lesions are coming back, soas a surgeon, you can take one
or two lesions more.
But in most of the cases thoselesions are popping up again and
again and again, and everywhereon the head or even on the
hands, on the nose, on the ears.
So at one point surgery is nothappening anymore.
Right, and what is the nextstandard treatment is that
(13:45):
people get chemotherapy in formof a cream formulation, for
example, a famous drug, oldchemotherapy drug,
5-fluorouracil that's whatpeople get is first.
Or another drug, diclofenac.
It's not a chemotherapy but itis reducing the inflammation,
(14:07):
anti-inflammatory drug.
It's helping for a certainperiod of time, but after
certain months the drug doesn'twork anymore.
Chemotherapy it helps for acertain period of time, but it
it's also not a curative drug.
And 5-fluoruracil has theproblem that it has very strong
(14:30):
side effects on the skin.
Very strong skin irritation iscaused by this particular drug.
When this chemotherapy doesn'twork anymore, there is the next
treatment.
It's called Aldara.
Aldara or Imiquimod, and thisis an immune therapy.
(14:51):
This is a very strong, verysevere immunotherapy that can
also not cure the patient, butit has a very strong efficacy to
clean many of the lesions.
The problem is that this drugis literally burning your skin.
(15:13):
It makes even holes in the skinand that's a big problem that
many patients do not want to usethat drug anymore after having
severe side effects.
If you Google Aldara images,then you will see how the
patients look like.
So my team many years ago saidwe have to try to find out
(15:38):
something for this cancer.
There is no drug really curingthose patients.
There is no drug really curingthose patients and after a while
many patients are gettingmetastatic non-melanoma skin
cancer, also called cutaneoussquamous cell carcinoma.
So we tested our drug in thoseactinic keratosis patients.
(15:59):
We wanted to see what the drugis doing to the patients when we
get those patients at the earlystage of the disease and what
is the drug doing to thepatients when we get patients at
the advanced stage of thedisease.
And I'm very proud to say thatat the early stage of the
disease we had 93% of completeor almost complete response,
(16:26):
which is a phenomenal result,and most of the patients got
curative treatment, so thelesions didn't come back six
months after the treatment.
At the moment Wow yeah, goahead.
So this is very positivebecause those patients are not
getting no melanoma and thepatients with advanced stage
(16:48):
disease they had around 50%complete response, or almost
complete response, so meaningthe half of the patients we were
able to eliminate all thelesions and this was also a very
successful result, especiallyknowing that our drug didn't
(17:11):
have almost no side effects.
The only side effect that wereported was actually dry skin
for a period of treatment offour weeks during the treatment,
for a period of treatment offour weeks during the treatment.
Ben Comer (17:26):
That sounds very promising and I want to come
back to your priorities andplans for Bimoralisib going
forward.
But I think you made thisdiscovery with your sister at
the University of Basel and I'dlike to hear a little bit about
spinning out Picur, which wasthe company that you created to
(17:49):
develop this drug.
And again, our audience iscomprised of biotech builders,
some scientist founders who areinterested in starting a company
based on, perhaps, a discoverythey made in their lab.
What can you say about spinningout that company from the
(18:13):
university?
How you funded it?
What would you say there?
Vladimir Cmiljanovic, Ph.D. (18:18):
So first of all, discovering all of
those things at university wasa challenge, because usually
university is not dedicated tothe drug discovery, at least in
Switzerland.
You do the basic research, butas soon as you are done with the
basic research, uh, you are notable to easily find the money
(18:39):
because the university alwayssays this is the part for the
big farm, and they are right.
So we were able to organize alot of funding between 10 and 50
million from differentfoundations, national science
foundations, from otherfoundations to really nicely
(19:00):
characterize our basic research.
That was the first success.
But at one point I actuallywanted to be a chemistry
professor and I wanted to do thefurther research in that
direction.
But this was not possible touse the money for this
particular project as we weretoo advanced for, uh, academics,
(19:22):
too advanced for University.
And I realized now it's the timeto found the company and I
wanted to actually be professorin chemistry by having somebody
else running that company.
But then about one year later Irealized it's a dream, thinking
that somebody else can yourproduct and your company and not
(19:45):
you, because the, the investors, everybody wanted to see
inventors doing that.
So I got one important investor.
It was a private bank frombasel in switzerland, our first
investor, and they told me look,we would like to invest there,
but we would like that youreally stop your academic career
(20:06):
, that you stop yourhabilitation and that you move
to your own company.
And if you do that, then wewill see that your commitment is
strong.
And I did that.
So I talked to my father first,and my father was a good
chemistry entrepreneur in Europeand I asked him do you think I
(20:29):
should do that?
And he said if you don't dothis, you will regret your whole
life.
If you do it, you're also goingto regret because this is going
to need super hard work.
I'm never regretting that.
I decided to be entrepreneur andit was amazing journey so far.
But this is, you know, you needto be very resilient, very
(20:55):
persistent, hardworking days,nights, years and then and then
you have good results financeresults, research results,
commercial results, etc.
So we decided to found thecompany, to make the first
funding and then, with the firstpreclinical proof of concept
(21:20):
data, I was able then toconvince friends and family and
many other family offices inSwitzerland and later
institutional investors to fundour project in a step-by-step
approach, but first alwaysfriends and family are there.
University we were the firstproject where university
invested in our case, so youneed to convince many people and
(21:45):
then, with more advancedresults, bigger investors are
also going to get interested tofund the project.
Ben Comer (21:54):
Now, were you still playing handball at this stage,
or had you already retired fromthe sport by that point?
Vladimir Cmiljanovic, Ph.D. (22:00):
I retired.
I retired.
I'm now 45.
It is actually not easy to playhandball, uh.
You need to be reallyprofessionally active because
this sport is very, very dynamic, uh, and you have to be top
informed to be able to play it.
I stopped it, but I wasactually a university teacher of
(22:23):
handball for many years andtoday I have.
Many of my investors are myfriends from from handball time.
Today they are successfulentrepreneurs.
Being being in the sport helpedme a lot with my own
entrepreneurial endeavor.
Ben Comer (22:42):
Oh, that's really interesting.
I want to say, getting back toPicour, you got the initial
funding.
You set up the company.
What you know then?
What?
What were some of the?
Did you have to hire staff?
What were some of the initialchallenges you know starting out
in 2011?
Vladimir Cmiljanovic, Ph.D. (23:00):
Yes , so I actually didn't have any
funding at the beginning, but Iknew I have an amazing drug in
my hands to be further developed.
So all the, as I told you, withthe previous drug Affinitor, I
had a very nice collaborationwith Novartis top management
(23:20):
people.
So I went to Novartis and Ioffered to their at that time
chief scientific officer andglobal director of the kindness
platform, doriano Favro.
I offered him the job because Iknew he has only few years to
get retired and I convinced himto do the early retirement.
(23:43):
So I didn't have cash to offerhim but I offered him shares of
the company and later, when Igot the funding, I offered him
also the salary.
But as he knew very good aboutdrug as my competitor, I was
able to convince him to join thecompany.
When he joined the company, Iconvinced the next one, the
(24:06):
global health medicinalchemistry, novartis, mark Lang.
Mark Lang and Doriano Favreau.
They are true pioneers becausethey discovered the drugs like
Gleevec or Tasigna or Femaravery famous cancer drugs, yeah,
and I was able to get them onboard.
And when external investors sawwhat kind of names are coming
(24:28):
to my company, leaving BigPharma and coming to a startup
in biotech, that's how I gotmore trust by investors and then
one after the other started toinvest.
So that was the first move andthen, after that, I was able to,
with more data, to convinceinstitutional investors, and
(24:51):
today I even have governments asshareholders, as we were able
to convince even governments tosupport our projects.
So so hiring the staff was thefirst step, funding the second,
execution of the preclinical andclinical development plans, and
(25:12):
then, when you get good data,then you usually go to talk to
big pharma companies and youactually do the partnering.
Ben Comer (25:24):
And is that what you did with Picur?
Did you partner with a bigpharma on that drug?
Vladimir Cmiljanovic, Ph.D. (25:30):
I started to partner all in 2017,
but then I had one surprisingelement in my career, one very
surprising one.
I'll tell you exactly whathappened.
I suddenly, my one of mylargest investors from US, from
(25:54):
Menlo Park, decided actually totake the control of the company,
and in a very unfriendly way,and this was a disaster for me
as a scientist and entrepreneur.
Disaster for shareholders ingeneral, because in this case,
(26:15):
you talk about hostile takeoveror unfriendly takeover.
So I had three unfriendlytakeovers led by that investor.
Why?
Because they wanted to controlthe company for their own
interest and their own benefits,and they were able to do that
because of the previousinvestments that they had made
(26:38):
Exactly.
So they were all in the company.
They had not majority of theshares, but they had a certain
amount of shares.
And then they started to buyout other investors to get
majority of the shares.
And when they got majority ofthe shares, then I needed to
leave my own company, where Ibuilt everything with my sister
(26:59):
together.
Wow.
So yeah, what?
Ben Comer (27:02):
did you do?
What did you do?
Vladimir Cmiljanovic, Ph.D. (27:04):
So this was a very, very difficult
time in my life.
It was very difficult for mywhole family.
It was very difficult for mebecause I was emotionally
connected to that molecule andwhy Because also of my mother,
who we lost on cancer.
So at one point I losteverything and what I did.
(27:30):
First I took some break ofcouple of months to digest
everything, but I decided tocontinue my fight in a more
smart way.
My advisor, who was very closeto me at that time, told me my
fight in a more smart way.
My advisor, who was very closeto me at that time, told me
(27:51):
first you need to learn toemotionally decouple from that
compound, although it is soimportant for your life.
This was me.
Ben Comer (27:57):
And has your mother's name in the name of the
compound.
Vladimir Cmiljanovic, P (28:00):
Exactly so.
I needed first to do that step,which was probably the most
difficult step in my life.
But I did that and I started tobuild a new company called
Swiss Rockets and I said I'mgoing out to build with my team.
My whole team from peak yearlost the jobs, so I brought all
(28:25):
of them back to Swiss Rocketsand I decided with them together
to build a new rocket sciencewith a rocket speed and Swiss
precision quality.
That's the name of SwissRockets, founded after we lost
the company end of 2017.
I founded the company in 2018,swiss Rockets, founded after we
lost the company end of 2017.
(28:45):
I founded the company in 2018,swiss Rockets.
Everything I learned before Iintegrated into Swiss Rockets so
that those things not happenagain.
For example, today we areselling only the shares, without
voting rights, and that's amore difficult pathway, but so
(29:06):
far we were able to fundraise alot of money and to succeed.
But back to your previousquestion very shortly.
What happened afterwards?
Covid crisis came.
Switzerland was one of thefirst countries in the world
getting COVID lockdown and withmy company, swiss Rockets, I
started to supply hospitals inSwitzerland to help them to go
(29:30):
out of that crisis, because mosthospitals in Europe and
worldwide did not have medicalequipment needed to master the
COVID lockdown.
I was able to successfullydeliver medicinal masks and many
other equipments that hospitalsin Switzerland needed.
Afterwards I expanded thatbusiness to many other European
(29:50):
countries.
Two years after doing thatbusiness I had enough money to
acquire my previous company.
I bought PQ back.
Wow, this is today the companyTorQ.
I renamed the company so fromPR3K and Cure to mTOR and Cure,
and company is named today TorQand the compound that was on
(30:16):
hold for a few years.
I continued further development, finished the phase two
clinical trial and now we are inprocess of the phase two
clinical trial and now we are inprocess of entering phase three
clinical trial withbreakthrough results.
Ben Comer (30:28):
And not only that, you've also founded what four
additional companies that are.
Is it four that are part ofSwiss Rockets, which is a kind
of incubator?
Yeah, so tell us about how thathappened and maybe how the
incubator model works.
Vladimir Cmiljanovic, Ph.D. (30:45):
Yes , so, Swiss Rockets was founded
as incubator and accelerator.
That means we offer to ourstartup companies a laboratory
space, office space andmanufacturing space.
We can do everything.
What beef farmer can do,manufacturing space, we can do.
(31:05):
Everything will be farmer cando.
It doesn't matter.
Do you have antibodies, atechnology, a small molecule as
a technology, or a vaccine as atechnology?
So that's the incubatorcharacter of C-SRX.
Ben Comer (31:13):
It's excellent.
On the manufacturing part.
Sorry to sorry to interrupt you, vlad um.
Did you build thatmanufacturing capability or do
you have existing partnershipswith you know contract
manufacturers that?
Vladimir Cmiljanovic, Ph.D. (31:26):
you work with.
We have partnerships withcontract manufacturers, but I
took a few of my billionairesfrom the first company.
I took them.
They were very loyal to me andI took them as shareholders in
the Swiss Rockets, took them asshareholders in the Swiss
rockets and one of them also wasbuilding the whole
(31:48):
infrastructure, evenmanufacturing facilities.
So we have access tomanufacturing facilities that do
not belong to Swiss rocketsitself but to one of the key
shareholders.
So we have exclusive rights touse that manufacturing facility.
And that's very important whenyou have a startup company
(32:13):
without money for infrastructure.
We deliver that as an incubatorand that's the first part of our
investment.
The first part of ourinvestment.
Second part of our investmentwe are investing now in each of
our subsidiary companies byourself and we bring money also
for our investment network tosupport those companies to go
(32:36):
out of the funding issues.
So we give them money and asaccelerator, we are providing
services.
We are top scientists fromXRosh, novartis or other
scientists, senior scientists weare outsourcing them to
subsidiary companies and we havethem running the operations.
(32:56):
Other scientists, seniorscientists we are outsourcing
them to subsidiary companies andwe have them running the
operations.
With that we are bringing theexpertise of drug development
into subsidiary companies.
We are minimizing the risks offailures and, after the clinical
approval concept, phase two, weare partnering with big pharma,
whether selling individualsubsidiary companies or even
(33:19):
doing partnerships in regard ofindividual assets, individual
compounds.
This is something that we nowscaled up after actually, during
the COVID crisis, baselgovernment supported us to build
(33:41):
a new project, building liveattenuated virus vaccines, and
we started to build with themost modern technology called
reverse genetic engineering tobuild live attenuated SARS-CoV-2
virus.
Engineering to build liveattenuated SARS-CoV-2 virus and
live attenuated SARS-CoV-2 virusis something that has been
(34:05):
shown being dramatically moresuperior than mRNA vaccines or
any other vaccines.
And we published several naturepapers and then we got an
interview with CNN Interviewwith CNN and CNN was talking
(34:28):
about our nature data.
That was in 2022.
And then we got the call frompeople from NIH motivating us to
submit our grant application toNIH as they are believing that
(34:49):
we have a very, very promisingnasal spray COVID-19 vaccine.
Ben Comer (34:55):
Right, and this is.
We're talking about RocketVax,I believe, one of the portfolio
companies under the umbrella ofSwiss Rockets.
It's a live attenuated virusyou mentioned.
It's nasally administeredthrough the nose.
What tell, maybe just brieflytell us about the other
companies under Swiss Rocketsand the therapeutic areas or
(35:18):
modalities they're working in?
Vladimir Cmiljanovic, Ph.D. (35:19):
Yes , so RocketVax is working on the
next generation virus vaccine.
As I said, we have partnershipwith the US company Emergent.
There Emergent is one of theworld-leading vaccine companies.
We have the company Torque,which I mentioned before, this
dual pH-3K M2 inhibitor fordifferent solid tumors but also
(35:42):
skin cancer.
We have the company TorpedoPharmaceuticals developing next
generation radioligand therapiesbased on a new best-in-class
radioisotope called Terbium 161.
This radioisotope calledTerbium 161.
And this radioisotope wasdeveloped first time by my wife,
(36:06):
nadia, at ETH Zurich.
Eth is the analog of the US MIT.
That's where Nadia and myselfmet together and Nadia is one of
the world leading nuclearpharmacists.
So she developed thatradioisotope as first and she
has shown as first that thisradioisotope has a very, very
(36:30):
powerful anti-cancer activityapplied specifically for certain
patients.
In her case she tested the drugfirst on neuroendocrine tumor
patients and when I saw that asher colleague scientist at that
time, I decided that actually weshould combine our research and
(36:54):
her research to make throughthat combination anti-cancer
activity even stronger.
But we combined also ourprivate life, so to say.
Today we have a wonderful boyand we are working together
today in our company Swissrockets, where Nadia is leading
the nuclear medicine department,and the company torpedo.
(37:16):
So radio ligand therapies issomething where we invest a lot
of money and where we believe wehave drugs with breakthrough
results.
And we have the company in myrain myra the the short
abbreviation of miraculousimmune therapies because we have
(37:39):
a very, very interesting drug,interesting for multiple
sclerosis patients.
So we acquired from oneGerman-based biotech their
technology and we used theirtechnology to develop a new drug
against multiple sclerosis.
(38:01):
In the first four patients drugshowed curative treatment,
which was very, very nice to see.
We improved the drug furtherand we are now in process of
preparing for the next clinicaltrial testing this drug in
(38:21):
multiple sclerosis patients.
So it's a company forautoimmune disorders.
We have another company calledRocket Isotopes where we have
established manufacturing ofisotopes, manufacturing of
isotopes, manufacturing ofisotopes for nuclear medicine,
which company Torpedo is usingat the moment.
(38:43):
But in future we can offer thatalso to other companies.
And we are preparing now tospin out the next startup
company acting in area ofneurology where we discovered
with our colleagues from UK thatthe drug that we are developing
(39:03):
, that if you inject that drugin a dead peripheral nerve the
peripheral nerve is going toregrow into a new one.
So we're actually working inregeneration of peripheral
nerves.
So those are the companieswhere we are focusing at the
moment.
Enough work for the next coupleof years and I hope that we are
(39:31):
going to succeed with all ofthose companies.
And so far all the companiesare going very well, with really
very promising results.
Ben Comer (39:42):
It's fascinating about Torpedo.
Everyone that is listening tothis show will know about the
level of excitement aroundradiopharmaceuticals and maybe,
in particular, radioligandtherapies.
I have to say you have a prettyimpressive family, vlad, to
have all of these members.
I'm sure your son will becoming in to lead a company at
(40:04):
some point.
But for the manufacturing andtell me the name of the
manufacturing facility for theradio ligand or for the isotopes
Rocket isotopes, rocketisotopes what was the investment
like?
Was it significant to buildthat facility?
And you said, eventually you'llallow other companies to
(40:26):
potentially use it or contractwith you as well.
Is that the plan?
That's the plan.
Vladimir Cmiljanovic, Ph.D. (40:31):
So so far, in all those companies
which I mentioned before, weinvested around 250 million
swiss francs, almost, let's say,up to 300 million us dollars,
and now we are expanding to tous.
I'm planning also to move to usfor a couple of years with my
(40:53):
family because we are nowlooking for new opportunities in
the US.
I just came back fromCalifornia where we have
realized there are a lot of verygood startup biotech companies
so we want to continue our jobsin the US as well.
And manufacturing facility.
(41:14):
We have partnered with theircanton, so we got actually the
infrastructure.
We just invested to upgradethat facility to get a new one
where we can do the job.
And now, with other partners,we are planning to expand
further facilities in the US andalso in.
Ben Comer (41:34):
Europe, so you're planning to move to the US?
It's a good segue to a questionI wanted to ask you about the
challenges for Europeancompanies and organizations
seeking to access the US marketor expand into the US market.
What are the existing barriersthat you face, vlad, and how do
(41:58):
you overcome those?
Vladimir Cmiljanovic, Ph.D. (42:01):
US was always the country in my
opinion, one of the mostinnovative countries in the
biotech and pharma area.
But Basel, switzerland, whereI'm based, is actually the true
originator of the pharmaindustry.
As you know, roche, innovatisin the past, ciba, geigy, sando
all those companies areheadquartered in Basel.
(42:23):
So Switzerland is a trueinnovation in biotech and pharma
.
Absolutely, it was always thecase and now, as you see, due to
the new situation, you see thatmany companies are moving
manufacturing of their productsin the US.
I think this is very good forUS and it will generate a lot of
(42:50):
added value to the US.
But even independently fromthat situation, I was always in
contact with leadinguniversities of the US and I
have there many good friends inscience and medicine and we
would like to use theopportunity to work in the US
(43:12):
with leading US scientists tomake new very promising projects
to be able to cure certainaggressive diseases like cancer.
So, independently from thosecurrent challenges, it was
always the idea to move thereand today we have great
opportunities to do that whilekeeping the headquarter in Basel
(43:37):
, in Switzerland.
Ben Comer (43:45):
Are the policy environment under the Trump
administration, the tariffs, thewhole package of activity
that's happening in the US.
Did that hasten your decisionto move into the US or no?
You were already on thetrajectory to come over prior to
the most recent US election.
Vladimir Cmiljanovic, Ph.D. (44:04):
Yes , trajectory to come over prior
to the most recent US election,vasilis KOTLAKOTAVICIUS yes, it
was completely independent fromthe current tariffs.
I know that a lot of big pharmacompanies are now restructuring
, but for us, as an R&D companycompany, we are only, let's say,
challenged getting the moneyfrom investors, because today,
investors are hesitating toinvest as fast as they did in
(44:27):
the past.
Everything is differentnowadays.
Funding is the challenge formany startups, and this is
always like that.
When you have stronggeopolitical issues worldwide,
investors are stepping back.
They are investing themdifferently, less risk-adversed,
and this is something that eachcompany needs to try to survive
(44:52):
, needs to challenge and findcreative solutions.
But independently from thecurrent situation, we plan to go
to US, working with top USinnovators, but also bringing
our markets to one of thelargest markets in the world.
Ben Comer (45:11):
Do you have a sense of the trend in terms of
investors?
You just came back fromCalifornia.
What's your sense of howinvestors are feeling?
Do you feel like they're soonto be coming back into, I guess,
more activity, investmentactivity into biotech?
Are they still a bit frozen atthe moment?
(45:32):
Obviously, the IPO market ismore or less closed at the
moment, but what would you sayabout how you feel in terms of
the trend for fundraising in thenext year or so?
Vladimir Cmiljanovic, Ph.D. (45:48):
So far.
Many investors are stillinvesting only a part of that
what they invested in the past.
Many of them are on hold withtheir investments, some vcs.
They are investing still some.
Some are still on hold.
So in general, the amount ofinvestments was dramatically
(46:11):
reduced in comparison to yearsbefore and I think the most
important thing is thatdifferent wars that we have now
on a global level, they have tostop.
To normalize the situation.
We have to start thinking abouteconomy in a different way and
(46:36):
I think as soon as the wars stop, I think economy will need some
time, so several years torecover.
Maybe you know, even afterstopping the war, several years
are needed that economy comes tothe normal situation on a
global level and I think eachindustry is now getting
(47:02):
challenged because of thecurrent global situation.
We have Biotechs, for sure, butI think it's very important that
we continue doing investmentsin the biotech and pharma area
to treat difficult diseases, butalso to be aware that soon a
(47:22):
new virus might come.
California is now full ofinfected birds with H5N1 bird
flu virus, so this virus couldemerge anytime, which would be a
disaster for the whole planet.
I hope that we are not going tohave that scenario, but if this
would happen, but the companiesare those which are going to
(47:46):
save the world.
That's very important to know.
Ben Comer (47:50):
Right, right.
I want to end with just aquestion about your top
priorities for the rest of thisyear, vlad.
You mentioned already thatBimeralisib is moving into late
stages.
I believe that's your lateststage asset among the companies,
right?
So maybe give us a sense ofyour kind of immediate
(48:12):
short-term plans for thatcompound.
And then I think I also heardyou say that Swiss Rockets, at
least for maybe a year or two,is all set in terms of its
portfolio of companies.
So maybe you aren't looking toadd companies at this point, but
tell us about your prioritiesand give us a sense of what
(48:35):
Swiss Rockets will be up to inthe next year or so.
Vladimir Cmiljanovic, Ph.D. (48:38):
So the highest priority is to bring
Bimeralizib in phase threeclinical trials in actinic
keratosis and to be on themarket in about two years from
now.
Ben Comer (48:49):
Now, will that be through a big pharma partnership
to conduct a phase three, orwill you do that?
Vladimir Cmiljanovic, Ph.D. (48:57):
We are talking now to different big
pharma companies and thediscussions are very, very
positive.
We realize there is a lot ofinterest for this drug,
especially knowing that actinickeratosis alone is a market of
about 8 to 10 billion US dollarson a global level, saying that
this is a very large indication.
(49:17):
Many people have that diseaseand the interest is very high.
So that that's good for us,because then we could also
partner and fund the phase threewith our partner together.
Potential acquisition of thatproduct could be also a pathway
forward, as there are fewcompanies expressing the
(49:41):
partnership with that direction.
But there is also an option todo fundraising by ourselves,
whether with private investorsor institutional investors or
both, or even doing IPO ifpossible, depending on the
situation, so that we canexecute the phase three clinical
trial by ourselves.
(50:01):
So we are open for all options.
We are working on all options inparallel and we will decide in
the next months what is the bestsolution for company Tokyo.
And then in parallel we areworking on torpedo drugs.
They are moving very fastforward.
Our leading product is terbiumPSMA drug for prostate cancer.
(50:26):
We want to treat metastaticprostate cancer very effectively
, but also prostate cancer atthe early stage with that
particular drug.
So this is something also veryimportant for us as we see
really strong benefits to thecancer patients and this drug is
(50:47):
now entering next clinicaltrial.
We go into phase one slashphase two clinical trials for
different patient targets andcompany RocketVax is now
entering phase one clinicaldevelopment with its nasal spray
(51:07):
COVID-19 vaccine, supported byNational Institutes of Health
and the US.
Ben Comer (51:14):
Right, excellent.
Well, vlad, I've really enjoyedspeaking with you today.
Thanks so much for coming onthe US Right Excellent.
Well, vlad, I've really enjoyedspeaking with you today.
Thanks so much for coming onthe podcast.
Vladimir Cmiljanovic, Ph. (51:22):
Thank you so much, Ben, for your
invitation for a very nicediscussion, and thank you for
your interest as well.
Ben Comer (51:29):
We've been speaking with Vladimir Smiljanovich,
founder and CEO at Swiss Rockets.
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 weeklyvideocasts of these
conversations every Monday underthe Business of Biotech tab at
lifescienceleadercom.
(51:51):
We'll see you next week andthanks as for listening.
Welcome back to the Business of Biotech.
I'm your host, Ben Comer, chiefEditor at Life Science Leader,
and today I'm pleased to speakwith Vladimir Cmiljanovic, an
award-winning scientist andfounder and CEO at Swiss Rockets
AG, a biotech incubator andaccelerator working across
several drug modalities andtherapeutic areas.
(00:27):
Vladimir is the co-discoverer,along with his sister, Natasha
Cmiljanovic, of bimiralisib,which is currently in
development for actinickeratosis or AK, which are
precancerous lesions in the skinthat often develop into skin
cancer.
I'm excited to talk to Vladabout the discovery of
(00:50):
bimiralicib, spinning out acompany to develop that drug,
the twists and turns andadditional company formation
work he's been involved withsince that discovery, how Swiss
Rockets the incubator works andwhat he's planning for the
future.
Thanks so much for being here,Vlad.
Thank works and what he'splanning for the future.
Thanks so much for being here,Vlad.
Vladimir Cmiljanovic, Ph. (01:08):
Thank you, ben, so much for inviting
me, and I'm very happy to betoday with you and people also
listening to this podcast.
Ben Comer (01:16):
Me too, and as we do on the business of biotech, Vlad
, I'd like to get to know you alittle bit how you got started
in this business, what yourmotivations are, what
circumstances led you into thefield of drug discovery
initially.
Vladimir Cmiljanovic, Ph (01:34):
That's a very good question.
So actually, when I was only afive-year-old boy only a five
years old boy um, I only said tomy mom one day I'm gonna find a
drug against cancer.
And probably I said that to herbecause of the love I had to my
(01:55):
mother of course, my father too, but my mother because my mom
lost her mom, my grandmotherwhen she was 12 years old on
leukemia.
So I never met my realgrandmother and, and due to that
love to my mom, I already atthat time I knew that actually
that's something I would like todo.
Many years later, I realizedthis is my mission on this earth
(02:19):
, looking for new anti-cancerdrugs, and I grew up up in
Serbia, in Eastern Europe, whereI was a professional team
handball player.
In Europe this is one of themost popular sports.
It's like rugby, but just on asmaller field, and I was playing
(02:39):
handball professionally andusing the money from
professional handball,reinvesting that money to my
education in chemistry, and in2003 I started to work within
university of basel inswitzerland, where I was living
and playing professionalhandball.
Later I started to work on anew class of enzymes, so-called
(03:07):
lipid kinases, and I startedactually to discover new
molecules and that was a bigsuccess.
We actually discovered somevery important enzymes called
mTOR and PI3K Kinesis in ourbody.
My professors discovered thosekinesis.
(03:29):
I was working with ProfessorMichael, who discovered TOR or
mTOR later, who is today in theboard of directors of our
company, swiss Rockets.
I was also working with peoplefrom Harvard Medical School,
professor Luke Huntley.
He discovered P3K-alpha.
He was director of HarvardMedical School and I was working
(03:54):
on the first generationmolecules called rapamycin
analogs, based on the discoveryof my professor Michael, and
then Leighton Nov novartis bigpharma company, also here based
in basel as a headquarter.
They started to collaboratewith university of basel and
(04:14):
they did the whole furtherdevelopment of a rapamycin
analog.
That has been, in 2010,registered for different solid
tumor cancers and the drug istoday known in the US and
worldwide as Afinitor orEverolimus.
That's how everything started.
We became very well known asscientists worldwide, also in
(04:37):
the industry, for thoseachievements.
But I knew at that time thatthis is just the beginning,
because I knew how much we donot know about those enzymes and
I had a very strong passion todiscover further things in that
area.
I invited my sister, natasha,to come from Serbia to
(04:59):
Switzerland as she studiedmedicine sorry, the chemistry,
medicinal chemistry in Serbia.
We started to work together inBasel and we discovered
molecules that can block mTORand its twin brother enzyme
called PR3K.
They have almost identicalstructure so they look like
twins and they have twodifferent, very important
(05:24):
functions.
Mtor is controlling the growthof cancer cells and PRTK is
controlling the metabolism ofcancer cells, actually the
production of sugar within thecancer cells.
So we wanted to discover a drugthat can block both enzymes at
the same time, stopping thegrowth of cancer cells on one
(05:45):
side and on another sidestopping the production of sugar
within the cancer cells.
No sugar, no energy, and youliterally starve the cancer
cells out.
That was the mechanism of actionthat we have proven very
successfully with the inhibitorcalled B-Miralizib.
B means dual PR3KM2 inhibitionand mira was the name of our
(06:08):
mother, so we put it her namethere to do something nice and
also to to on on her owner totry to have many patients as
possible.
So bimiralizib has beendeveloped so far in solid tumors
, in lymphomas, different typesof tumors, as an orally
(06:30):
bioavailable drug, but in formof the topical application,
meaning in form of a cream orgel of the same drug, we were
able to develop a product forskin cancer, and now we have new
results showing breakthroughscience of this drug in that
particular cancer type.
Ben Comer (06:51):
Yeah, and I want to ask you some follow-up on Ben
Morales' Sib in terms of whereit is in development, how you
landed on that AK target skincancer.
But I wonder if first you couldjust talk through
co-discovering that with yoursister.
I'm interested to hear yourthoughts about what that was
(07:13):
like, how it happened, what itmeant for both you and Natasha.
Vladimir Cmiljanovic, Ph. (07:19):
Thank you Also a very nice question.
So we actually wanted to learnmore about those enzymes in
general.
We knew that those enzymes playone of the most important roles
in cancer, but at that time,early 2000 and and later, so up
to the 2011, we wanted tounderstand what is really the
(07:44):
role of these two enzymes and westarted.
In about 2003, we started todiscover molecules that can
literally act as spy molecules,investigating about those
enzymes without that enzymesknow that they are labeled with
(08:06):
small molecules, but learningabout their function and about
their biology.
And this was actually my masterthesis developing molecules
which are going to help uslearning more about the biology
of those important enzymesimportant for cancer metabolism.
Ben Comer (08:27):
Know thine enemy right.
You had to get to know thosepathways to learn how to inhibit
them.
Is that right Exactly?
Vladimir Cmiljanovic, P (08:34):
exactly .
And then, having that research,step by step, we found out we
literally have very interestinginhibitors of those enzymes out.
We literally have veryinteresting inhibitors of those
enzymes.
So if you inhibit them you canstop certain functions and you
could have a direct benefit forcancer patients.
And when we realized that weactually have a new drug in our
(08:57):
hands, then nothing was there tostop us to go with the further
research and further developmentin direction anti-cancer drug
discovery.
And later we founded our owncompany and organized a lot of
investments, a lot of fundingand today we are at the late
(09:19):
stage of the clinicaldevelopment.
Ben Comer (09:21):
Right.
So you made this discovery, wasthere initial indication that
you had in mind, you know?
Did you initially think that itwould target solid tumors?
Did you already think that itcould be applicable in skin
cancer?
How did you think about that,how you would develop it?
You know, start the developmentwork, yes.
Vladimir Cmiljanovic, Ph.D. (09:39):
So first, we tested the drug in
many different cancer cells.
In those experiments we foundout that this drug actually has
a very unique mechanismExhausting the cancer cells,
could be applied theoreticallyin 200 out of 250 different
cancers.
And then for many cancers wetested that in vivo experiments
(10:04):
in animal models, in tumorxenograft models.
But then when we founded ourcompany, we needed to decide for
further development what arethe cancers that we want to
tackle?
We decided to test the drug innon-Hodgkin lymphomas, in
different solid tumors like headand neck cancer, breast cancer,
(10:24):
prostate cancer or glioblastoma, for example very aggressive
brain tumor, because we madethat drug also brain penetrant.
The drug has excellent brainpenetration properties and
therefore it could be alsoapplied to different brain
tumors.
So we tested that over theyears in clinical trials in the
(10:46):
US and in Europe and we realizedthe drug can work there.
But one of my scientists saidokay, it would be very
interesting if you could alsotry to test your drug in one of
the most common skin cancers andone of the most common tumours
(11:06):
at all, so-called non-melanomaskin cancer.
And why?
Because this non-melanoma skincancer has also activated P3K
mTOR pathway, probably more thanother tumours.
So what we did?
We started to test that first,also in animal models.
This was very successful.
We did that with Professor JohnSecora from University of
(11:31):
Pennsylvania and we realizedthat we are literally melting
the tumors of the myces.
We cured all of those myces andwe realized, wow, this is the
best result that we have so farin the career.
We literally, with a cream, weare melting the tumor that was
(11:55):
on the skin of those animalmodels.
All the animals were cured withthe drug.
And then we worked further toorganize the funding to test
also the same drug in humanpatients.
And now we have confirmed thatthe drug works excellent, with
breakthrough results in phase 2clinical trials.
(12:15):
What is the result?
Very shortly, we have shownthat in this disease called
actinic keratosis, which is aprecursor, pre-malignant disease
of non-melanoma skin cancer.
By the way, non-melanoma skincancer is the second most common
tumor among all the tumors, soit's a very frequent cancer
(12:37):
coming because of the UV lightradiation.
So the older we are, the moresensitive is our skin to the UV
light and people are gettingfirst actinic keratosis.
Ben Comer (12:54):
And these are some of the lesions that listeners will
know they've probably hadeither themselves or their
family members have gone in tohave these surgically removed.
Is that right?
Vladimir Cmiljanovic, Ph.D. (13:04):
Yes , family members have gone in to
have these surgically removed.
Is that right?
Yes, first, actually, people,the surgeons, the dermatologists
or dermatologists they aredoing the surgical removal of
those lesions by some people.
The lesions are coming back, soas a surgeon, you can take one
or two lesions more.
(13:24):
The lesions are coming back, soas a surgeon, you can take one
or two lesions more.
But in most of the cases thoselesions are popping up again and
again and again, and everywhereon the head or even on the
hands, on the nose, on the ears.
So at one point surgery is nothappening anymore.
Right, and what is the nextstandard treatment is that
(13:45):
people get chemotherapy in formof a cream formulation, for
example, a famous drug, oldchemotherapy drug,
5-fluorouracil that's whatpeople get is first.
Or another drug, diclofenac.
It's not a chemotherapy but itis reducing the inflammation,
(14:07):
anti-inflammatory drug.
It's helping for a certainperiod of time, but after
certain months the drug doesn'twork anymore.
Chemotherapy it helps for acertain period of time, but it
it's also not a curative drug.
And 5-fluoruracil has theproblem that it has very strong
(14:30):
side effects on the skin.
Very strong skin irritation iscaused by this particular drug.
When this chemotherapy doesn'twork anymore, there is the next
treatment.
It's called Aldara.
Aldara or Imiquimod, and thisis an immune therapy.
(14:51):
This is a very strong, verysevere immunotherapy that can
also not cure the patient, butit has a very strong efficacy to
clean many of the lesions.
The problem is that this drugis literally burning your skin.
(15:13):
It makes even holes in the skinand that's a big problem that
many patients do not want to usethat drug anymore after having
severe side effects.
If you Google Aldara images,then you will see how the
patients look like.
So my team many years ago saidwe have to try to find out
(15:38):
something for this cancer.
There is no drug really curingthose patients.
There is no drug really curingthose patients and after a while
many patients are gettingmetastatic non-melanoma skin
cancer, also called cutaneoussquamous cell carcinoma.
So we tested our drug in thoseactinic keratosis patients.
(15:59):
We wanted to see what the drugis doing to the patients when we
get those patients at the earlystage of the disease and what
is the drug doing to thepatients when we get patients at
the advanced stage of thedisease.
And I'm very proud to say thatat the early stage of the
disease we had 93% of completeor almost complete response,
(16:26):
which is a phenomenal result,and most of the patients got
curative treatment, so thelesions didn't come back six
months after the treatment.
At the moment Wow yeah, goahead.
So this is very positivebecause those patients are not
getting no melanoma and thepatients with advanced stage
(16:48):
disease they had around 50%complete response, or almost
complete response, so meaningthe half of the patients we were
able to eliminate all thelesions and this was also a very
successful result, especiallyknowing that our drug didn't
(17:11):
have almost no side effects.
The only side effect that wereported was actually dry skin
for a period of treatment offour weeks during the treatment,
for a period of treatment offour weeks during the treatment.
Ben Comer (17:26):
That sounds very promising and I want to come
back to your priorities andplans for Bimoralisib going
forward.
But I think you made thisdiscovery with your sister at
the University of Basel and I'dlike to hear a little bit about
spinning out Picur, which wasthe company that you created to
(17:49):
develop this drug.
And again, our audience iscomprised of biotech builders,
some scientist founders who areinterested in starting a company
based on, perhaps, a discoverythey made in their lab.
What can you say about spinningout that company from the
(18:13):
university?
How you funded it?
What would you say there?
Vladimir Cmiljanovic, Ph.D. (18:18):
So first of all, discovering all of
those things at university wasa challenge, because usually
university is not dedicated tothe drug discovery, at least in
Switzerland.
You do the basic research, butas soon as you are done with the
basic research, uh, you are notable to easily find the money
(18:39):
because the university alwayssays this is the part for the
big farm, and they are right.
So we were able to organize alot of funding between 10 and 50
million from differentfoundations, national science
foundations, from otherfoundations to really nicely
(19:00):
characterize our basic research.
That was the first success.
But at one point I actuallywanted to be a chemistry
professor and I wanted to do thefurther research in that
direction.
But this was not possible touse the money for this
particular project as we weretoo advanced for, uh, academics,
(19:22):
too advanced for University.
And I realized now it's the timeto found the company and I
wanted to actually be professorin chemistry by having somebody
else running that company.
But then about one year later Irealized it's a dream, thinking
that somebody else can yourproduct and your company and not
(19:45):
you, because the, the investors, everybody wanted to see
inventors doing that.
So I got one important investor.
It was a private bank frombasel in switzerland, our first
investor, and they told me look,we would like to invest there,
but we would like that youreally stop your academic career
(20:06):
, that you stop yourhabilitation and that you move
to your own company.
And if you do that, then wewill see that your commitment is
strong.
And I did that.
So I talked to my father first,and my father was a good
chemistry entrepreneur in Europeand I asked him do you think I
(20:29):
should do that?
And he said if you don't dothis, you will regret your whole
life.
If you do it, you're also goingto regret because this is going
to need super hard work.
I'm never regretting that.
I decided to be entrepreneur andit was amazing journey so far.
But this is, you know, you needto be very resilient, very
(20:55):
persistent, hardworking days,nights, years and then and then
you have good results financeresults, research results,
commercial results, etc.
So we decided to found thecompany, to make the first
funding and then, with the firstpreclinical proof of concept
(21:20):
data, I was able then toconvince friends and family and
many other family offices inSwitzerland and later
institutional investors to fundour project in a step-by-step
approach, but first alwaysfriends and family are there.
University we were the firstproject where university
invested in our case, so youneed to convince many people and
(21:45):
then, with more advancedresults, bigger investors are
also going to get interested tofund the project.
Ben Comer (21:54):
Now, were you still playing handball at this stage,
or had you already retired fromthe sport by that point?
Vladimir Cmiljanovic, Ph.D. (22:00):
I retired.
I retired.
I'm now 45.
It is actually not easy to playhandball, uh.
You need to be reallyprofessionally active because
this sport is very, very dynamic, uh, and you have to be top
informed to be able to play it.
I stopped it, but I wasactually a university teacher of
(22:23):
handball for many years andtoday I have.
Many of my investors are myfriends from from handball time.
Today they are successfulentrepreneurs.
Being being in the sport helpedme a lot with my own
entrepreneurial endeavor.
Ben Comer (22:42):
Oh, that's really interesting.
I want to say, getting back toPicour, you got the initial
funding.
You set up the company.
What you know then?
What?
What were some of the?
Did you have to hire staff?
What were some of the initialchallenges you know starting out
in 2011?
Vladimir Cmiljanovic, Ph.D. (23:00):
Yes , so I actually didn't have any
funding at the beginning, but Iknew I have an amazing drug in
my hands to be further developed.
So all the, as I told you, withthe previous drug Affinitor, I
had a very nice collaborationwith Novartis top management
(23:20):
people.
So I went to Novartis and Ioffered to their at that time
chief scientific officer andglobal director of the kindness
platform, doriano Favro.
I offered him the job because Iknew he has only few years to
get retired and I convinced himto do the early retirement.
(23:43):
So I didn't have cash to offerhim but I offered him shares of
the company and later, when Igot the funding, I offered him
also the salary.
But as he knew very good aboutdrug as my competitor, I was
able to convince him to join thecompany.
When he joined the company, Iconvinced the next one, the
(24:06):
global health medicinalchemistry, novartis, mark Lang.
Mark Lang and Doriano Favreau.
They are true pioneers becausethey discovered the drugs like
Gleevec or Tasigna or Femaravery famous cancer drugs, yeah,
and I was able to get them onboard.
And when external investors sawwhat kind of names are coming
(24:28):
to my company, leaving BigPharma and coming to a startup
in biotech, that's how I gotmore trust by investors and then
one after the other started toinvest.
So that was the first move andthen, after that, I was able to,
with more data, to convinceinstitutional investors, and
(24:51):
today I even have governments asshareholders, as we were able
to convince even governments tosupport our projects.
So so hiring the staff was thefirst step, funding the second,
execution of the preclinical andclinical development plans, and
(25:12):
then, when you get good data,then you usually go to talk to
big pharma companies and youactually do the partnering.
Ben Comer (25:24):
And is that what you did with Picur?
Did you partner with a bigpharma on that drug?
Vladimir Cmiljanovic, Ph.D. (25:30):
I started to partner all in 2017,
but then I had one surprisingelement in my career, one very
surprising one.
I'll tell you exactly whathappened.
I suddenly, my one of mylargest investors from US, from
(25:54):
Menlo Park, decided actually totake the control of the company,
and in a very unfriendly way,and this was a disaster for me
as a scientist and entrepreneur.
Disaster for shareholders ingeneral, because in this case,
(26:15):
you talk about hostile takeoveror unfriendly takeover.
So I had three unfriendlytakeovers led by that investor.
Why?
Because they wanted to controlthe company for their own
interest and their own benefits,and they were able to do that
because of the previousinvestments that they had made
(26:38):
Exactly.
So they were all in the company.
They had not majority of theshares, but they had a certain
amount of shares.
And then they started to buyout other investors to get
majority of the shares.
And when they got majority ofthe shares, then I needed to
leave my own company, where Ibuilt everything with my sister
(26:59):
together.
Wow.
So yeah, what?
Ben Comer (27:02):
did you do?
What did you do?
Vladimir Cmiljanovic, Ph.D. (27:04):
So this was a very, very difficult
time in my life.
It was very difficult for mywhole family.
It was very difficult for mebecause I was emotionally
connected to that molecule andwhy Because also of my mother,
who we lost on cancer.
So at one point I losteverything and what I did.
(27:30):
First I took some break ofcouple of months to digest
everything, but I decided tocontinue my fight in a more
smart way.
My advisor, who was very closeto me at that time, told me my
fight in a more smart way.
My advisor, who was very closeto me at that time, told me
(27:51):
first you need to learn toemotionally decouple from that
compound, although it is soimportant for your life.
This was me.
Ben Comer (27:57):
And has your mother's name in the name of the
compound.
Vladimir Cmiljanovic, P (28:00):
Exactly so.
I needed first to do that step,which was probably the most
difficult step in my life.
But I did that and I started tobuild a new company called
Swiss Rockets and I said I'mgoing out to build with my team.
My whole team from peak yearlost the jobs, so I brought all
(28:25):
of them back to Swiss Rocketsand I decided with them together
to build a new rocket sciencewith a rocket speed and Swiss
precision quality.
That's the name of SwissRockets, founded after we lost
the company end of 2017.
I founded the company in 2018,swiss Rockets, founded after we
lost the company end of 2017.
(28:45):
I founded the company in 2018,swiss Rockets.
Everything I learned before Iintegrated into Swiss Rockets so
that those things not happenagain.
For example, today we areselling only the shares, without
voting rights, and that's amore difficult pathway, but so
(29:06):
far we were able to fundraise alot of money and to succeed.
But back to your previousquestion very shortly.
What happened afterwards?
Covid crisis came.
Switzerland was one of thefirst countries in the world
getting COVID lockdown and withmy company, swiss Rockets, I
started to supply hospitals inSwitzerland to help them to go
(29:30):
out of that crisis, because mosthospitals in Europe and
worldwide did not have medicalequipment needed to master the
COVID lockdown.
I was able to successfullydeliver medicinal masks and many
other equipments that hospitalsin Switzerland needed.
Afterwards I expanded thatbusiness to many other European
(29:50):
countries.
Two years after doing thatbusiness I had enough money to
acquire my previous company.
I bought PQ back.
Wow, this is today the companyTorQ.
I renamed the company so fromPR3K and Cure to mTOR and Cure,
and company is named today TorQand the compound that was on
(30:16):
hold for a few years.
I continued further development, finished the phase two
clinical trial and now we are inprocess of the phase two
clinical trial and now we are inprocess of entering phase three
clinical trial withbreakthrough results.
Ben Comer (30:28):
And not only that, you've also founded what four
additional companies that are.
Is it four that are part ofSwiss Rockets, which is a kind
of incubator?
Yeah, so tell us about how thathappened and maybe how the
incubator model works.
Vladimir Cmiljanovic, Ph.D. (30:45):
Yes , so, Swiss Rockets was founded
as incubator and accelerator.
That means we offer to ourstartup companies a laboratory
space, office space andmanufacturing space.
We can do everything.
What beef farmer can do,manufacturing space, we can do.
(31:05):
Everything will be farmer cando.
It doesn't matter.
Do you have antibodies, atechnology, a small molecule as
a technology, or a vaccine as atechnology?
So that's the incubatorcharacter of C-SRX.
Ben Comer (31:13):
It's excellent.
On the manufacturing part.
Sorry to sorry to interrupt you, vlad um.
Did you build thatmanufacturing capability or do
you have existing partnershipswith you know contract
manufacturers that?
Vladimir Cmiljanovic, Ph.D. (31:26):
you work with.
We have partnerships withcontract manufacturers, but I
took a few of my billionairesfrom the first company.
I took them.
They were very loyal to me andI took them as shareholders in
the Swiss Rockets, took them asshareholders in the Swiss
rockets and one of them also wasbuilding the whole
(31:48):
infrastructure, evenmanufacturing facilities.
So we have access tomanufacturing facilities that do
not belong to Swiss rocketsitself but to one of the key
shareholders.
So we have exclusive rights touse that manufacturing facility.
And that's very important whenyou have a startup company
(32:13):
without money for infrastructure.
We deliver that as an incubatorand that's the first part of our
investment.
The first part of ourinvestment.
Second part of our investmentwe are investing now in each of
our subsidiary companies byourself and we bring money also
for our investment network tosupport those companies to go
(32:36):
out of the funding issues.
So we give them money and asaccelerator, we are providing
services.
We are top scientists fromXRosh, novartis or other
scientists, senior scientists weare outsourcing them to
subsidiary companies and we havethem running the operations.
(32:56):
Other scientists, seniorscientists we are outsourcing
them to subsidiary companies andwe have them running the
operations.
With that we are bringing theexpertise of drug development
into subsidiary companies.
We are minimizing the risks offailures and, after the clinical
approval concept, phase two, weare partnering with big pharma,
whether selling individualsubsidiary companies or even
(33:19):
doing partnerships in regard ofindividual assets, individual
compounds.
This is something that we nowscaled up after actually, during
the COVID crisis, baselgovernment supported us to build
(33:41):
a new project, building liveattenuated virus vaccines, and
we started to build with themost modern technology called
reverse genetic engineering tobuild live attenuated SARS-CoV-2
virus.
Engineering to build liveattenuated SARS-CoV-2 virus and
live attenuated SARS-CoV-2 virusis something that has been
(34:05):
shown being dramatically moresuperior than mRNA vaccines or
any other vaccines.
And we published several naturepapers and then we got an
interview with CNN Interviewwith CNN and CNN was talking
(34:28):
about our nature data.
That was in 2022.
And then we got the call frompeople from NIH motivating us to
submit our grant application toNIH as they are believing that
(34:49):
we have a very, very promisingnasal spray COVID-19 vaccine.
Ben Comer (34:55):
Right, and this is.
We're talking about RocketVax,I believe, one of the portfolio
companies under the umbrella ofSwiss Rockets.
It's a live attenuated virusyou mentioned.
It's nasally administeredthrough the nose.
What tell, maybe just brieflytell us about the other
companies under Swiss Rocketsand the therapeutic areas or
(35:18):
modalities they're working in?
Vladimir Cmiljanovic, Ph.D. (35:19):
Yes , so RocketVax is working on the
next generation virus vaccine.
As I said, we have partnershipwith the US company Emergent.
There Emergent is one of theworld-leading vaccine companies.
We have the company Torque,which I mentioned before, this
dual pH-3K M2 inhibitor fordifferent solid tumors but also
(35:42):
skin cancer.
We have the company TorpedoPharmaceuticals developing next
generation radioligand therapiesbased on a new best-in-class
radioisotope called Terbium 161.
This radioisotope calledTerbium 161.
And this radioisotope wasdeveloped first time by my wife,
(36:06):
nadia, at ETH Zurich.
Eth is the analog of the US MIT.
That's where Nadia and myselfmet together and Nadia is one of
the world leading nuclearpharmacists.
So she developed thatradioisotope as first and she
has shown as first that thisradioisotope has a very, very
(36:30):
powerful anti-cancer activityapplied specifically for certain
patients.
In her case she tested the drugfirst on neuroendocrine tumor
patients and when I saw that asher colleague scientist at that
time, I decided that actually weshould combine our research and
(36:54):
her research to make throughthat combination anti-cancer
activity even stronger.
But we combined also ourprivate life, so to say.
Today we have a wonderful boyand we are working together
today in our company Swissrockets, where Nadia is leading
the nuclear medicine department,and the company torpedo.
(37:16):
So radio ligand therapies issomething where we invest a lot
of money and where we believe wehave drugs with breakthrough
results.
And we have the company in myrain myra the the short
abbreviation of miraculousimmune therapies because we have
(37:39):
a very, very interesting drug,interesting for multiple
sclerosis patients.
So we acquired from oneGerman-based biotech their
technology and we used theirtechnology to develop a new drug
against multiple sclerosis.
(38:01):
In the first four patients drugshowed curative treatment,
which was very, very nice to see.
We improved the drug furtherand we are now in process of
preparing for the next clinicaltrial testing this drug in
(38:21):
multiple sclerosis patients.
So it's a company forautoimmune disorders.
We have another company calledRocket Isotopes where we have
established manufacturing ofisotopes, manufacturing of
isotopes, manufacturing ofisotopes for nuclear medicine,
which company Torpedo is usingat the moment.
(38:43):
But in future we can offer thatalso to other companies.
And we are preparing now tospin out the next startup
company acting in area ofneurology where we discovered
with our colleagues from UK thatthe drug that we are developing
(39:03):
, that if you inject that drugin a dead peripheral nerve the
peripheral nerve is going toregrow into a new one.
So we're actually working inregeneration of peripheral
nerves.
So those are the companieswhere we are focusing at the
moment.
Enough work for the next coupleof years and I hope that we are
(39:31):
going to succeed with all ofthose companies.
And so far all the companiesare going very well, with really
very promising results.
Ben Comer (39:42):
It's fascinating about Torpedo.
Everyone that is listening tothis show will know about the
level of excitement aroundradiopharmaceuticals and maybe,
in particular, radioligandtherapies.
I have to say you have a prettyimpressive family, vlad, to
have all of these members.
I'm sure your son will becoming in to lead a company at
(40:04):
some point.
But for the manufacturing andtell me the name of the
manufacturing facility for theradio ligand or for the isotopes
Rocket isotopes, rocketisotopes what was the investment
like?
Was it significant to buildthat facility?
And you said, eventually you'llallow other companies to
(40:26):
potentially use it or contractwith you as well.
Is that the plan?
That's the plan.
Vladimir Cmiljanovic, Ph.D. (40:31):
So so far, in all those companies
which I mentioned before, weinvested around 250 million
swiss francs, almost, let's say,up to 300 million us dollars,
and now we are expanding to tous.
I'm planning also to move to usfor a couple of years with my
(40:53):
family because we are nowlooking for new opportunities in
the US.
I just came back fromCalifornia where we have
realized there are a lot of verygood startup biotech companies
so we want to continue our jobsin the US as well.
And manufacturing facility.
(41:14):
We have partnered with theircanton, so we got actually the
infrastructure.
We just invested to upgradethat facility to get a new one
where we can do the job.
And now, with other partners,we are planning to expand
further facilities in the US andalso in.
Ben Comer (41:34):
Europe, so you're planning to move to the US?
It's a good segue to a questionI wanted to ask you about the
challenges for Europeancompanies and organizations
seeking to access the US marketor expand into the US market.
What are the existing barriersthat you face, vlad, and how do
(41:58):
you overcome those?
Vladimir Cmiljanovic, Ph.D. (42:01):
US was always the country in my
opinion, one of the mostinnovative countries in the
biotech and pharma area.
But Basel, switzerland, whereI'm based, is actually the true
originator of the pharmaindustry.
As you know, roche, innovatisin the past, ciba, geigy, sando
all those companies areheadquartered in Basel.
(42:23):
So Switzerland is a trueinnovation in biotech and pharma
.
Absolutely, it was always thecase and now, as you see, due to
the new situation, you see thatmany companies are moving
manufacturing of their productsin the US.
I think this is very good forUS and it will generate a lot of
(42:50):
added value to the US.
But even independently fromthat situation, I was always in
contact with leadinguniversities of the US and I
have there many good friends inscience and medicine and we
would like to use theopportunity to work in the US
(43:12):
with leading US scientists tomake new very promising projects
to be able to cure certainaggressive diseases like cancer.
So, independently from thosecurrent challenges, it was
always the idea to move thereand today we have great
opportunities to do that whilekeeping the headquarter in Basel
(43:37):
, in Switzerland.
Ben Comer (43:45):
Are the policy environment under the Trump
administration, the tariffs, thewhole package of activity
that's happening in the US.
Did that hasten your decisionto move into the US or no?
You were already on thetrajectory to come over prior to
the most recent US election.
Vladimir Cmiljanovic, Ph.D. (44:04):
Yes , trajectory to come over prior
to the most recent US election,vasilis KOTLAKOTAVICIUS yes, it
was completely independent fromthe current tariffs.
I know that a lot of big pharmacompanies are now restructuring
, but for us, as an R&D companycompany, we are only, let's say,
challenged getting the moneyfrom investors, because today,
investors are hesitating toinvest as fast as they did in
(44:27):
the past.
Everything is differentnowadays.
Funding is the challenge formany startups, and this is
always like that.
When you have stronggeopolitical issues worldwide,
investors are stepping back.
They are investing themdifferently, less risk-adversed,
and this is something that eachcompany needs to try to survive
(44:52):
, needs to challenge and findcreative solutions.
But independently from thecurrent situation, we plan to go
to US, working with top USinnovators, but also bringing
our markets to one of thelargest markets in the world.
Ben Comer (45:11):
Do you have a sense of the trend in terms of
investors?
You just came back fromCalifornia.
What's your sense of howinvestors are feeling?
Do you feel like they're soonto be coming back into, I guess,
more activity, investmentactivity into biotech?
Are they still a bit frozen atthe moment?
(45:32):
Obviously, the IPO market ismore or less closed at the
moment, but what would you sayabout how you feel in terms of
the trend for fundraising in thenext year or so?
Vladimir Cmiljanovic, Ph.D. (45:48):
So far.
Many investors are stillinvesting only a part of that
what they invested in the past.
Many of them are on hold withtheir investments, some vcs.
They are investing still some.
Some are still on hold.
So in general, the amount ofinvestments was dramatically
(46:11):
reduced in comparison to yearsbefore and I think the most
important thing is thatdifferent wars that we have now
on a global level, they have tostop.
To normalize the situation.
We have to start thinking abouteconomy in a different way and
(46:36):
I think as soon as the wars stop, I think economy will need some
time, so several years torecover.
Maybe you know, even afterstopping the war, several years
are needed that economy comes tothe normal situation on a
global level and I think eachindustry is now getting
(47:02):
challenged because of thecurrent global situation.
We have Biotechs, for sure, butI think it's very important that
we continue doing investmentsin the biotech and pharma area
to treat difficult diseases, butalso to be aware that soon a
(47:22):
new virus might come.
California is now full ofinfected birds with H5N1 bird
flu virus, so this virus couldemerge anytime, which would be a
disaster for the whole planet.
I hope that we are not going tohave that scenario, but if this
would happen, but the companiesare those which are going to
(47:46):
save the world.
That's very important to know.
Ben Comer (47:50):
Right, right.
I want to end with just aquestion about your top
priorities for the rest of thisyear, vlad.
You mentioned already thatBimeralisib is moving into late
stages.
I believe that's your lateststage asset among the companies,
right?
So maybe give us a sense ofyour kind of immediate
(48:12):
short-term plans for thatcompound.
And then I think I also heardyou say that Swiss Rockets, at
least for maybe a year or two,is all set in terms of its
portfolio of companies.
So maybe you aren't looking toadd companies at this point, but
tell us about your prioritiesand give us a sense of what
(48:35):
Swiss Rockets will be up to inthe next year or so.
Vladimir Cmiljanovic, Ph.D. (48:38):
So the highest priority is to bring
Bimeralizib in phase threeclinical trials in actinic
keratosis and to be on themarket in about two years from
now.
Ben Comer (48:49):
Now, will that be through a big pharma partnership
to conduct a phase three, orwill you do that?
Vladimir Cmiljanovic, Ph.D. (48:57):
We are talking now to different big
pharma companies and thediscussions are very, very
positive.
We realize there is a lot ofinterest for this drug,
especially knowing that actinickeratosis alone is a market of
about 8 to 10 billion US dollarson a global level, saying that
this is a very large indication.
(49:17):
Many people have that diseaseand the interest is very high.
So that that's good for us,because then we could also
partner and fund the phase threewith our partner together.
Potential acquisition of thatproduct could be also a pathway
forward, as there are fewcompanies expressing the
(49:41):
partnership with that direction.
But there is also an option todo fundraising by ourselves,
whether with private investorsor institutional investors or
both, or even doing IPO ifpossible, depending on the
situation, so that we canexecute the phase three clinical
trial by ourselves.
(50:01):
So we are open for all options.
We are working on all options inparallel and we will decide in
the next months what is the bestsolution for company Tokyo.
And then in parallel we areworking on torpedo drugs.
They are moving very fastforward.
Our leading product is terbiumPSMA drug for prostate cancer.
(50:26):
We want to treat metastaticprostate cancer very effectively
, but also prostate cancer atthe early stage with that
particular drug.
So this is something also veryimportant for us as we see
really strong benefits to thecancer patients and this drug is
(50:47):
now entering next clinicaltrial.
We go into phase one slashphase two clinical trials for
different patient targets andcompany RocketVax is now
entering phase one clinicaldevelopment with its nasal spray
(51:07):
COVID-19 vaccine, supported byNational Institutes of Health
and the US.
Ben Comer (51:14):
Right, excellent.
Well, vlad, I've really enjoyedspeaking with you today.
Thanks so much for coming onthe US Right Excellent.
Well, vlad, I've really enjoyedspeaking with you today.
Thanks so much for coming onthe podcast.
Vladimir Cmiljanovic, Ph. (51:22):
Thank you so much, Ben, for your
invitation for a very nicediscussion, and thank you for
your interest as well.
Ben Comer (51:29):
We've been speaking with Vladimir Smiljanovich,
founder and CEO at Swiss Rockets.
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 weeklyvideocasts of these
conversations every Monday underthe Business of Biotech tab at
lifescienceleadercom.
(51:51):
We'll see you next week andthanks as for listening.
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