Business Of Biotech
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Business Of Biotech
Building A Biotech Incubator And Accelerator With Swiss Rockets Founder And CEO Vladimir Cmiljanovic, Ph.D.
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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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Welcome back to the Business of Biotech. I'm your host, Ben Comer, chief Editor at Life Science Leader, and today I'm pleased to speak with Vladimir Cmiljanovic, an award-winning scientist and founder and CEO at Swiss Rockets AG, a biotech incubator and accelerator working across several drug modalities and therapeutic areas. Vladimir is the co-discoverer, along with his sister, Natasha Cmiljanovic, of bimiralisib, which is currently in development for actinic keratosis or AK, which are precancerous lesions in the skin that often develop into skin cancer. I'm excited to talk to Vlad about the discovery of bimiralicib, spinning out a company to develop that drug, the twists and turns and additional company formation work he's been involved with since that discovery, how Swiss Rockets the incubator works and what he's planning for the future. Thanks so much for being here, Vlad. Thank works and what he's planning for the future. Thanks so much for being here, Vlad.
Vladimir Cmiljanovic, Ph.D.:Thank you, ben, so much for inviting me, and I'm very happy to be today with you and people also listening to this podcast.
Ben Comer:Me too, and as we do on the business of biotech, Vlad, I'd like to get to know you a little bit how you got started in this business, what your motivations are, what circumstances led you into the field of drug discovery initially.
Vladimir Cmiljanovic, Ph.D.:That's a very good question. So actually, when I was only a five-year-old boy only a five years old boy um, I only said to my mom one day I'm gonna find a drug against cancer. And probably I said that to her because of the love I had to my mother of course, my father too, but my mother because my mom lost her mom, my grandmother when she was 12 years old on leukemia. So I never met my real grandmother and, and due to that love to my mom, I already at that time I knew that actually that's something I would like to do. Many years later, I realized this is my mission on this earth, looking for new anti-cancer drugs, and I grew up up in Serbia, in Eastern Europe, where I was a professional team handball player. In Europe this is one of the most popular sports. It's like rugby, but just on a smaller field, and I was playing handball professionally and using the money from professional handball, reinvesting that money to my education in chemistry, and in 2003 I started to work within university of basel in switzerland, where I was living and playing professional handball. Later I started to work on a new class of enzymes, so-called lipid kinases, and I started actually to discover new molecules and that was a big success. We actually discovered some very important enzymes called mTOR and PI3K Kinesis in our body. My professors discovered those kinesis. I was working with Professor Michael, who discovered TOR or mTOR later, who is today in the board of directors of our company, swiss Rockets. I was also working with people from Harvard Medical School, professor Luke Huntley. He discovered P3K-alpha. He was director of Harvard Medical School and I was working on the first generation molecules called rapamycin analogs, based on the discovery of my professor Michael, and then Leighton Nov novartis big pharma company, also here based in basel as a headquarter. They started to collaborate with university of basel and they did the whole further development of a rapamycin analog. That has been, in 2010, registered for different solid tumor cancers and the drug is today known in the US and worldwide as Afinitor or Everolimus.
Vladimir Cmiljanovic, Ph.D.:That's how everything started. We became very well known as scientists worldwide, also in the industry, for those achievements. But I knew at that time that this is just the beginning, because I knew how much we do not know about those enzymes and I had a very strong passion to discover further things in that area. I invited my sister, natasha, to come from Serbia to Switzerland as she studied medicine sorry, the chemistry, medicinal chemistry in Serbia.
Vladimir Cmiljanovic, Ph.D.:We started to work together in Basel and we discovered molecules that can block mTOR and its twin brother enzyme called PR3K. They have almost identical structure so they look like twins and they have two different, very important functions. Mtor is controlling the growth of cancer cells and PRTK is controlling the metabolism of cancer cells, actually the production of sugar within the cancer cells. So we wanted to discover a drug that can block both enzymes at the same time, stopping the growth of cancer cells on one side and on another side stopping the production of sugar within the cancer cells. No sugar, no energy, and you literally starve the cancer cells out.
Vladimir Cmiljanovic, Ph.D.:That was the mechanism of action that we have proven very successfully with the inhibitor called B-Miralizib. B means dual PR3KM2 inhibition and mira was the name of our mother, so we put it her name there to do something nice and also to to on on her owner to try to have many patients as possible. So bimiralizib has been developed so far in solid tumors, in lymphomas, different types of tumors, as an orally bioavailable drug, but in form of the topical application, meaning in form of a cream or gel of the same drug, we were able to develop a product for skin cancer, and now we have new results showing breakthrough science of this drug in that particular cancer type.
Ben Comer:Yeah, and I want to ask you some follow-up on Ben Morales' Sib in terms of where it is in development, how you landed on that AK target skin cancer. But I wonder if first you could just talk through co-discovering that with your sister. I'm interested to hear your thoughts about what that was like, how it happened, what it meant for both you and Natasha.
Vladimir Cmiljanovic, Ph.D.:Thank you Also a very nice question. So we actually wanted to learn more about those enzymes in general. We knew that those enzymes play one of the most important roles in cancer, but at that time, early 2000 and and later, so up to the 2011, we wanted to understand what is really the role of these two enzymes and we started. In about 2003, we started to discover molecules that can literally act as spy molecules, investigating about those enzymes without that enzymes know that they are labeled with small molecules, but learning about their function and about their biology. And this was actually my master thesis developing molecules which are going to help us learning more about the biology of those important enzymes important for cancer metabolism.
Ben Comer:Know thine enemy right. You had to get to know those pathways to learn how to inhibit them. Is that right Exactly?
Vladimir Cmiljanovic, Ph.D.:exactly. And then, having that research, step by step, we found out we literally have very interesting inhibitors of those enzymes out. We literally have very interesting inhibitors of those enzymes. So if you inhibit them you can stop certain functions and you could have a direct benefit for cancer patients. And when we realized that we actually have a new drug in our hands, then nothing was there to stop us to go with the further research and further development in direction anti-cancer drug discovery. And later we founded our own company and organized a lot of investments, a lot of funding and today we are at the late stage of the clinical development.
Ben Comer:Right. So you made this discovery, was there initial indication that you had in mind, you know? Did you initially think that it would target solid tumors? Did you already think that it could be applicable in skin cancer? How did you think about that, how you would develop it? You know, start the development work, yes.
Vladimir Cmiljanovic, Ph.D.:So first, we tested the drug in many different cancer cells. In those experiments we found out that this drug actually has a very unique mechanism Exhausting the cancer cells, could be applied theoretically in 200 out of 250 different cancers. And then for many cancers we tested that in vivo experiments in animal models, in tumor xenograft models. But then when we founded our company, we needed to decide for further development what are the cancers that we want to tackle? We decided to test the drug in non-Hodgkin lymphomas, in different solid tumors like head and neck cancer, breast cancer, prostate cancer or glioblastoma, for example very aggressive brain tumor, because we made that drug also brain penetrant. The drug has excellent brain penetration properties and therefore it could be also applied to different brain tumors. So we tested that over the years in clinical trials in the US and in Europe and we realized the drug can work there.
Vladimir Cmiljanovic, Ph.D.:But one of my scientists said okay, it would be very interesting if you could also try to test your drug in one of the most common skin cancers and one of the most common tumours at all, so-called non-melanoma skin cancer. And why? Because this non-melanoma skin cancer has also activated P3K mTOR pathway, probably more than other tumours. So what we did? We started to test that first, also in animal models. This was very successful. We did that with Professor John Secora from University of Pennsylvania and we realized that we are literally melting the tumors of the myces.
Vladimir Cmiljanovic, Ph.D.:We cured all of those myces and we realized, wow, this is the best result that we have so far in the career. We literally, with a cream, we are melting the tumor that was on the skin of those animal models. All the animals were cured with the drug. And then we worked further to organize the funding to test also the same drug in human patients. And now we have confirmed that the drug works excellent, with breakthrough results in phase 2 clinical trials. What is the result? Very shortly, we have shown that in this disease called actinic keratosis, which is a precursor, pre-malignant disease of non-melanoma skin cancer. By the way, non-melanoma skin cancer is the second most common tumor among all the tumors, so it's a very frequent cancer coming because of the UV light radiation. So the older we are, the more sensitive is our skin to the UV light and people are getting first actinic keratosis.
Ben Comer:And these are some of the lesions that listeners will know they've probably had either themselves or their family members have gone in to have these surgically removed. Is that right?
Vladimir Cmiljanovic, Ph.D.: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 are doing the surgical removal of those lesions by some people. The lesions are coming back, so as a surgeon, you can take one or two lesions more. The lesions are coming back, so as a surgeon, you can take one or two lesions more. But in most of the cases those lesions are popping up again and again and again, and everywhere on the head or even on the hands, on the nose, on the ears. So at one point surgery is not happening anymore.
Vladimir Cmiljanovic, Ph.D.:Right, and what is the next standard treatment is that people get chemotherapy in form of a cream formulation, for example, a famous drug, old chemotherapy drug, 5-fluorouracil that's what people get is first. Or another drug, diclofenac. It's not a chemotherapy but it is reducing the inflammation, anti-inflammatory drug. It's helping for a certain period of time, but after certain months the drug doesn't work anymore. Chemotherapy it helps for a certain period of time, but it it's also not a curative drug. And 5-fluoruracil has the problem that it has very strong side effects on the skin. Very strong skin irritation is caused by this particular drug. When this chemotherapy doesn't work anymore, there is the next treatment. It's called Aldara. Aldara or Imiquimod, and this is an immune therapy. This is a very strong, very severe immunotherapy that can also not cure the patient, but it has a very strong efficacy to clean many of the lesions. The problem is that this drug is literally burning your skin. It makes even holes in the skin and that's a big problem that many patients do not want to use that drug anymore after having severe side effects. If you Google Aldara images, then you will see how the patients look like.
Vladimir Cmiljanovic, Ph.D.:So my team many years ago said we have to try to find out something for this cancer. There is no drug really curing those patients. There is no drug really curing those patients and after a while many patients are getting metastatic non-melanoma skin cancer, also called cutaneous squamous cell carcinoma. So we tested our drug in those actinic keratosis patients. We wanted to see what the drug is doing to the patients when we get those patients at the early stage of the disease and what is the drug doing to the patients when we get patients at the advanced stage of the disease.
Vladimir Cmiljanovic, Ph.D.:And I'm very proud to say that at the early stage of the disease we had 93% of complete or almost complete response, which is a phenomenal result, and most of the patients got curative treatment, so the lesions didn't come back six months after the treatment. At the moment Wow yeah, go ahead. So this is very positive because those patients are not getting no melanoma and the patients with advanced stage disease they had around 50% complete response, or almost complete response, so meaning the half of the patients we were able to eliminate all the lesions and this was also a very successful result, especially knowing that our drug didn't have almost no side effects. The only side effect that we reported was actually dry skin for a period of treatment of four weeks during the treatment, for a period of treatment of four weeks during the treatment.
Ben Comer:That sounds very promising and I want to come back to your priorities and plans for Bimoralisib going forward. But I think you made this discovery with your sister at the University of Basel and I'd like to hear a little bit about spinning out Picur, which was the company that you created to develop this drug. And again, our audience is comprised of biotech builders, some scientist founders who are interested in starting a company based on, perhaps, a discovery they made in their lab. What can you say about spinning out that company from the university? How you funded it? What would you say there?
Vladimir Cmiljanovic, Ph.D.:So first of all, discovering all of those things at university was a challenge, because usually university is not dedicated to the drug discovery, at least in Switzerland. You do the basic research, but as soon as you are done with the basic research, uh, you are not able to easily find the money because the university always says this is the part for the big farm, and they are right. So we were able to organize a lot of funding between 10 and 50 million from different foundations, national science foundations, from other foundations to really nicely characterize our basic research. That was the first success. But at one point I actually wanted to be a chemistry professor and I wanted to do the further research in that direction. But this was not possible to use the money for this particular project as we were too advanced for, uh, academics, too advanced for University.
Vladimir Cmiljanovic, Ph.D.:And I realized now it's the time to found the company and I wanted to actually be professor in chemistry by having somebody else running that company. But then about one year later I realized it's a dream, thinking that somebody else can your product and your company and not you, because the, the investors, everybody wanted to see inventors doing that. So I got one important investor. It was a private bank from basel in switzerland, our first investor, and they told me look, we would like to invest there, but we would like that you really stop your academic career, that you stop your habilitation and that you move to your own company. And if you do that, then we will see that your commitment is strong.
Vladimir Cmiljanovic, Ph.D.:And I did that. So I talked to my father first, and my father was a good chemistry entrepreneur in Europe and I asked him do you think I should do that? And he said if you don't do this, you will regret your whole life. If you do it, you're also going to regret because this is going to need super hard work. I'm never regretting that.
Vladimir Cmiljanovic, Ph.D.:I decided to be entrepreneur and it was amazing journey so far. But this is, you know, you need to be very resilient, very persistent, hardworking days, nights, years and then and then you have good results finance results, research results, commercial results, etc. So we decided to found the company, to make the first funding and then, with the first preclinical proof of concept data, I was able then to convince friends and family and many other family offices in Switzerland and later institutional investors to fund our project in a step-by-step approach, but first always friends and family are there. University we were the first project where university invested in our case, so you need to convince many people and then, with more advanced results, bigger investors are also going to get interested to fund the project.
Ben Comer:Now, were you still playing handball at this stage, or had you already retired from the sport by that point?
Vladimir Cmiljanovic, Ph.D.:I retired. I retired. I'm now 45. It is actually not easy to play handball, uh. You need to be really professionally 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 was actually a university teacher of handball for many years and today I have. Many of my investors are my friends from from handball time. Today they are successful entrepreneurs. Being being in the sport helped me a lot with my own entrepreneurial endeavor.
Ben Comer:Oh, that's really interesting. I want to say, getting back to Picour, 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 initial challenges you know starting out in 2011?
Vladimir Cmiljanovic, Ph.D.:Yes, so I actually didn't have any funding at the beginning, but I knew I have an amazing drug in my hands to be further developed. So all the, as I told you, with the previous drug Affinitor, I had a very nice collaboration with Novartis top management people. So I went to Novartis and I offered to their at that time chief scientific officer and global director of the kindness platform, doriano Favro. I offered him the job because I knew he has only few years to get retired and I convinced him to do the early retirement. So I didn't have cash to offer him but I offered him shares of the company and later, when I got the funding, I offered him also the salary. But as he knew very good about drug as my competitor, I was able to convince him to join the company. When he joined the company, I convinced the next one, the global health medicinal chemistry, novartis, mark Lang.
Vladimir Cmiljanovic, Ph.D.:Mark Lang and Doriano Favreau. They are true pioneers because they discovered the drugs like Gleevec or Tasigna or Femara very famous cancer drugs, yeah, and I was able to get them on board. And when external investors saw what kind of names are coming to my company, leaving Big Pharma and coming to a startup in biotech, that's how I got more trust by investors and then one after the other started to invest. So that was the first move and then, after that, I was able to, with more data, to convince institutional investors, and today I even have governments as shareholders, as we were able to convince even governments to support our projects. So so hiring the staff was the first step, funding the second, execution of the preclinical and clinical development plans, and then, when you get good data, then you usually go to talk to big pharma companies and you actually do the partnering.
Ben Comer:And is that what you did with Picur? Did you partner with a big pharma on that drug?
Vladimir Cmiljanovic, Ph.D.:I started to partner all in 2017, but then I had one surprising element in my career, one very surprising one. I'll tell you exactly what happened. I suddenly, my one of my largest investors from US, from Menlo Park, decided actually to take 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 in general, because in this case, you talk about hostile takeover or unfriendly takeover. So I had three unfriendly takeovers led by that investor. Why? Because they wanted to control the company for their own interest and their own benefits, and they were able to do that because of the previous investments that they had made Exactly.
Vladimir Cmiljanovic, Ph.D.:So they were all in the company. They had not majority of the shares, but they had a certain amount of shares. And then they started to buy out other investors to get majority of the shares. And when they got majority of the shares, then I needed to leave my own company, where I built everything with my sister together. Wow. So yeah, what?
Ben Comer:did you do? What did you do?
Vladimir Cmiljanovic, Ph.D.:So this was a very, very difficult time in my life. It was very difficult for my whole family. It was very difficult for me because I was emotionally connected to that molecule and why Because also of my mother, who we lost on cancer. So at one point I lost everything and what I did. First I took some break of couple of months to digest everything, but I decided to continue my fight in a more smart way. My advisor, who was very close to me at that time, told me my fight in a more smart way. My advisor, who was very close to me at that time, told me first you need to learn to emotionally decouple from that compound, although it is so important for your life. This was me.
Ben Comer:And has your mother's name in the name of the compound.
Vladimir Cmiljanovic, Ph.D.: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 to build a new company called Swiss Rockets and I said I'm going out to build with my team. My whole team from peak year lost the jobs, so I brought all of them back to Swiss Rockets and I decided with them together to build a new rocket science with a rocket speed and Swiss precision quality. That's the name of Swiss Rockets, 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. I founded the company in 2018, swiss Rockets.
Vladimir Cmiljanovic, Ph.D.:Everything I learned before I integrated into Swiss Rockets so that those things not happen again. For example, today we are selling only the shares, without voting rights, and that's a more difficult pathway, but so far we were able to fundraise a lot of money and to succeed. But back to your previous question very shortly. What happened afterwards? Covid crisis came. Switzerland was one of the first countries in the world getting COVID lockdown and with my company, swiss Rockets, I started to supply hospitals in Switzerland to help them to go out of that crisis, because most hospitals in Europe and worldwide did not have medical equipment needed to master the COVID lockdown. I was able to successfully deliver medicinal masks and many other equipments that hospitals in Switzerland needed. Afterwards I expanded that business to many other European countries.
Vladimir Cmiljanovic, Ph.D.:Two years after doing that business I had enough money to acquire my previous company. I bought PQ back. Wow, this is today the company TorQ. I renamed the company so from PR3K and Cure to mTOR and Cure, and company is named today TorQ and the compound that was on hold for a few years. I continued further development, finished the phase two clinical trial and now we are in process of the phase two clinical trial and now we are in process of entering phase three clinical trial with breakthrough results.
Ben Comer:And not only that, you've also founded what four additional companies that are. Is it four that are part of Swiss Rockets, which is a kind of incubator? Yeah, so tell us about how that happened and maybe how the incubator model works.
Vladimir Cmiljanovic, Ph.D.:Yes, so, Swiss Rockets was founded as incubator and accelerator. That means we offer to our startup companies a laboratory space, office space and manufacturing space. We can do everything. What beef farmer can do, manufacturing space, we can do. Everything will be farmer can do. It doesn't matter. Do you have antibodies, a technology, a small molecule as a technology, or a vaccine as a technology? So that's the incubator character of C-SRX.
Ben Comer:It's excellent. On the manufacturing part. Sorry to sorry to interrupt you, vlad um. Did you build that manufacturing capability or do you have existing partnerships with you know contract manufacturers that?
Vladimir Cmiljanovic, Ph.D.:you work with. We have partnerships with contract manufacturers, but I took a few of my billionaires from the first company. I took them. They were very loyal to me and I took them as shareholders in the Swiss Rockets, took them as shareholders in the Swiss rockets and one of them also was building the whole infrastructure, even manufacturing facilities. So we have access to manufacturing facilities that do not belong to Swiss rockets itself but to one of the key shareholders. So we have exclusive rights to use that manufacturing facility. And that's very important when you have a startup company without money for infrastructure.
Vladimir Cmiljanovic, Ph.D.:We deliver that as an incubator and that's the first part of our investment. The first part of our investment. Second part of our investment we are investing now in each of our subsidiary companies by ourself and we bring money also for our investment network to support those companies to go out of the funding issues. So we give them money and as accelerator, we are providing services. We are top scientists from XRosh, novartis or other scientists, senior scientists we are outsourcing them to subsidiary companies and we have them running the operations. Other scientists, senior scientists we are outsourcing them to subsidiary companies and we have them running the operations. With that we are bringing the expertise of drug development into subsidiary companies.
Vladimir Cmiljanovic, Ph.D.:We are minimizing the risks of failures and, after the clinical approval concept, phase two, we are partnering with big pharma, whether selling individual subsidiary companies or even doing partnerships in regard of individual assets, individual compounds. This is something that we now scaled up after actually, during the COVID crisis, basel government supported us to build a new project, building live attenuated virus vaccines, and we started to build with the most modern technology called reverse genetic engineering to build live attenuated SARS-CoV-2 virus. Engineering to build live attenuated SARS-CoV-2 virus and live attenuated SARS-CoV-2 virus is something that has been shown being dramatically more superior than mRNA vaccines or any other vaccines. And we published several nature papers and then we got an interview with CNN Interview with CNN and CNN was talking about our nature data. That was in 2022. And then we got the call from people from NIH motivating us to submit our grant application to NIH as they are believing that we have a very, very promising nasal spray COVID-19 vaccine.
Ben Comer:Right, and this is. We're talking about RocketVax, I believe, one of the portfolio companies under the umbrella of Swiss Rockets. It's a live attenuated virus you mentioned. It's nasally administered through the nose. What tell, maybe just briefly tell us about the other companies under Swiss Rockets and the therapeutic areas or modalities they're working in?
Vladimir Cmiljanovic, Ph.D.:Yes, so RocketVax is working on the next generation virus vaccine. As I said, we have partnership with the US company Emergent. There Emergent is one of the world-leading vaccine companies. We have the company Torque, which I mentioned before, this dual pH-3K M2 inhibitor for different solid tumors but also skin cancer. We have the company Torpedo Pharmaceuticals developing next generation radioligand therapies based on a new best-in-class radioisotope called Terbium 161. This radioisotope called Terbium 161.
Vladimir Cmiljanovic, Ph.D.:And this radioisotope was developed first time by my wife, nadia, at ETH Zurich. Eth is the analog of the US MIT. That's where Nadia and myself met together and Nadia is one of the world leading nuclear pharmacists. So she developed that radioisotope as first and she has shown as first that this radioisotope has a very, very powerful anti-cancer activity applied specifically for certain patients. In her case she tested the drug first on neuroendocrine tumor patients and when I saw that as her colleague scientist at that time, I decided that actually we should combine our research and her research to make through that combination anti-cancer activity even stronger. But we combined also our private life, so to say. Today we have a wonderful boy and we are working together today in our company Swiss rockets, where Nadia is leading the nuclear medicine department, and the company torpedo.
Vladimir Cmiljanovic, Ph.D.:So radio ligand therapies is something where we invest a lot of money and where we believe we have drugs with breakthrough results. And we have the company in myra in myra the the short abbreviation of miraculous immune therapies because we have a very, very interesting drug, interesting for multiple sclerosis patients. So we acquired from one German-based biotech their technology and we used their technology to develop a new drug against multiple sclerosis. In the first four patients drug showed curative treatment, which was very, very nice to see. We improved the drug further and we are now in process of preparing for the next clinical trial testing this drug in multiple sclerosis patients. So it's a company for autoimmune disorders.
Vladimir Cmiljanovic, Ph.D.:We have another company called Rocket Isotopes where we have established manufacturing of isotopes, manufacturing of isotopes, manufacturing of isotopes for nuclear medicine, which company Torpedo is using at the moment. But in future we can offer that also to other companies. And we are preparing now to spin out the next startup company acting in area of neurology where we discovered with our colleagues from UK that the drug that we are developing, that if you inject that drug in a dead peripheral nerve the peripheral nerve is going to regrow into a new one. So we're actually working in regeneration of peripheral nerves. So those are the companies where we are focusing at the moment. Enough work for the next couple of years and I hope that we are going to succeed with all of those companies. And so far all the companies are going very well, with really very promising results.
Ben Comer:It's fascinating about Torpedo. Everyone that is listening to this show will know about the level of excitement around radiopharmaceuticals and maybe, in particular, radioligand therapies. I have to say you have a pretty impressive family, vlad, to have all of these members. I'm sure your son will be coming in to lead a company at some point. But for the manufacturing and tell me the name of the manufacturing facility for the radio ligand or for the isotopes Rocket isotopes, rocket isotopes what was the investment like? Was it significant to build that facility? And you said, eventually you'll allow other companies to potentially use it or contract with you as well. Is that the plan? That's the plan.
Vladimir Cmiljanovic, Ph.D.:So so far, in all those companies which I mentioned before, we invested around 250 million swiss francs, almost, let's say, up to 300 million us dollars, and now we are expanding to to us. I'm planning also to move to us for a couple of years with my family because we are now looking for new opportunities in the US. I just came back from California where we have realized there are a lot of very good startup biotech companies so we want to continue our jobs in the US as well. And manufacturing facility. We have partnered with their canton, so we got actually the infrastructure. We just invested to upgrade that 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 and also in.
Ben Comer:Europe, so you're planning to move to the US? It's a good segue to a question I wanted to ask you about the challenges for European companies and organizations seeking to access the US market or expand into the US market. What are the existing barriers that you face, vlad, and how do you overcome those?
Vladimir Cmiljanovic, Ph.D.:US was always the country in my opinion, one of the most innovative countries in the biotech and pharma area.
Vladimir Cmiljanovic, Ph.D.:But Basel, switzerland, where I'm based, is actually the true originator of the pharma industry. As you know, roche, innovatis in the past, ciba, geigy, sando all those companies are headquartered in Basel. So Switzerland is a true innovation in biotech and pharma. Absolutely, it was always the case and now, as you see, due to the new situation, you see that many companies are moving manufacturing of their products in the US. I think this is very good for US and it will generate a lot of added value to the US. But even independently from that situation, I was always in contact with leading universities of the US and I have there many good friends in science and medicine and we would like to use the opportunity to work in the US with leading US scientists to make new very promising projects to be able to cure certain aggressive diseases like cancer. So, independently from those current challenges, it was always the idea to move there and today we have great opportunities to do that while keeping the headquarter in Basel, in Switzerland.
Ben Comer:Are the policy environment under the Trump administration, the tariffs, the whole package of activity that's happening in the US. Did that hasten your decision to move into the US or no? You were already on the trajectory to come over prior to the most recent US election.
Vladimir Cmiljanovic, Ph.D.:Yes, trajectory to come over prior to the most recent US election, vasilis KOTLAKOTAVICIUS yes, it was completely independent from the current tariffs. I know that a lot of big pharma companies are now restructuring, but for us, as an R&D company company, we are only, let's say, challenged getting the money from investors, because today, investors are hesitating to invest as fast as they did in the past. Everything is different nowadays. Funding is the challenge for many startups, and this is always like that. When you have strong geopolitical issues worldwide, investors are stepping back. They are investing them differently, less risk-adversed, and this is something that each company needs to try to survive, needs to challenge and find creative solutions. But independently from the current situation, we plan to go to US, working with top US innovators, but also bringing our markets to one of the largest markets in the world.
Ben Comer:Do you have a sense of the trend in terms of investors? You just came back from California. What's your sense of how investors are feeling? Do you feel like they're soon to be coming back into, I guess, more activity, investment activity into biotech? Are they still a bit frozen at the moment? Obviously, the IPO market is more or less closed at the moment, but what would you say about how you feel in terms of the trend for fundraising in the next year or so?
Vladimir Cmiljanovic, Ph.D.:So far. Many investors are still investing only a part of that what they invested in the past. Many of them are on hold with their investments, some vcs. They are investing still some. Some are still on hold.
Vladimir Cmiljanovic, Ph.D.:So in general, the amount of investments was dramatically reduced in comparison to years before and I think the most important thing is that different wars that we have now on a global level, they have to stop. To normalize the situation. We have to start thinking about economy in a different way and I think as soon as the wars stop, I think economy will need some time, so several years to recover. Maybe you know, even after stopping the war, several years are needed that economy comes to the normal situation on a global level and I think each industry is now getting challenged because of the current global situation.
Vladimir Cmiljanovic, Ph.D.:We have Biotechs, for sure, but I think it's very important that we continue doing investments in the biotech and pharma area to treat difficult diseases, but also to be aware that soon a new virus might come. California is now full of infected birds with H5N1 bird flu virus, so this virus could emerge anytime, which would be a disaster for the whole planet. I hope that we are not going to have that scenario, but if this would happen, but the companies are those which are going to save the world. That's very important to know.
Ben Comer:Right, right. I want to end with just a question about your top priorities for the rest of this year, vlad. You mentioned already that Bimeralisib is moving into late stages. I believe that's your latest stage asset among the companies, right? So maybe give us a sense of your kind of immediate short-term plans for that compound. And then I think I also heard you 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 to add companies at this point, but tell us about your priorities and give us a sense of what Swiss Rockets will be up to in the next year or so.
Vladimir Cmiljanovic, Ph.D.:So the highest priority is to bring Bimeralizib in phase three clinical trials in actinic keratosis and to be on the market in about two years from now.
Ben Comer:Now, will that be through a big pharma partnership to conduct a phase three, or will you do that?
Vladimir Cmiljanovic, Ph.D.:We are talking now to different big pharma companies and the discussions are very, very positive. We realize there is a lot of interest for this drug, especially knowing that actinic keratosis alone is a market of about 8 to 10 billion US dollars on a global level, saying that this is a very large indication. Many people have that disease and the interest is very high. So that that's good for us, because then we could also partner and fund the phase three with our partner together. Potential acquisition of that product could be also a pathway forward, as there are few companies expressing the partnership with that direction. But there is also an option to do fundraising by ourselves, whether with private investors or institutional investors or both, or even doing IPO if possible, depending on the situation, so that we can execute the phase three clinical trial by ourselves. So we are open for all options.
Vladimir Cmiljanovic, Ph.D.:We are working on all options in parallel and we will decide in the next months what is the best solution for company Tokyo. And then in parallel we are working on torpedo drugs. They are moving very fast forward. Our leading product is terbium PSMA drug for prostate cancer. We want to treat metastatic prostate cancer very effectively, but also prostate cancer at the early stage with that particular drug. So this is something also very important for us as we see really strong benefits to the cancer patients and this drug is now entering next clinical trial. We go into phase one slash phase two clinical trials for different patient targets and company RocketVax is now entering phase one clinical development with its nasal spray COVID-19 vaccine, supported by National Institutes of Health and the US.
Ben Comer:Right, excellent. Well, vlad, I've really enjoyed speaking with you today. Thanks so much for coming on the US Right Excellent. Well, vlad, I've really enjoyed speaking with you today. Thanks so much for coming on the podcast.
Vladimir Cmiljanovic, Ph.D.:Thank you so much, Ben, for your invitation for a very nice discussion, and thank you for your interest as well.
Ben Comer:We've been speaking with Vladimir Smiljanovich, founder and CEO at Swiss Rockets. I'm Ben Comer and you've just listened to the Business of Biotech. Find us and subscribe anywhere you listen to podcasts and be sure to check out new weekly videocasts of these conversations every Monday under the Business of Biotech tab at lifescienceleadercom. We'll see you next week and thanks as for listening.
