Combined Therapeutics President & CEO Dr. Romain Micol is operating his company in a very noisy space, where hundreds of new biotechs have popped up on the coattails of a COVID-driven renewal of interest in mRNA vaccines. Micol recognizes that noise and the competition it brings for capital and mindshare. He's not only aware of it — he welcomes it. On this quick episode of the Business of Biotech podcast, Micol shares the unique approach Combined Tx is taking to distinguishing itself in the mRNA infectious disease and cancer vaccine space, from the delivery, safety, efficay, and business perspectives.
You've listened along for years -- now you can watch along, too! Go to bioprocessonline.com/solution/the-business-of-biotech-podcast, where you can put faces to voices as you watch hundreds of interviews with the world's best biotech builders. While you're there, subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!
Combined Therapeutics President & CEO Dr. Romain Micol is operating his company in a very noisy space, where hundreds of new biotechs have popped up on the coattails of a COVID-driven renewal of interest in mRNA vaccines. Micol recognizes that noise and the competition it brings for capital and mindshare. He's not only aware of it — he welcomes it. On this quick episode of the Business of Biotech podcast, Micol shares the unique approach Combined Tx is taking to distinguishing itself in the mRNA infectious disease and cancer vaccine space, from the delivery, safety, efficay, and business perspectives.
You've listened along for years -- now you can watch along, too! Go to bioprocessonline.com/solution/the-business-of-biotech-podcast, where you can put faces to voices as you watch hundreds of interviews with the world's best biotech builders. While you're there, subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!
The business of biotech is produced by LifeScienceConnect and its community of learning, solving and sourcing resources for biopharma decision makers. If you're working on biologics process development and manufacturing challenges, you need to swing by bioprocessonlinecom. If you're trying to stay ahead of the Cell or Gene Therapy curve, visit cellenginecom. When it's time to map out your clinical course, let clinicalleadercom help, and if optimizing outsourcing decisions is what you're after, check out OutsourcePharmacom. We're LifeScienceConnect and we're here to help. Dr Romain Micol is co-founder, president, ceo and director at Combined Therapeutics, and his academic accolades read like alphabet soup MD, mph, phd, mba, llm, and we'll throw in ADVAC just for good measure. I'm Matt Pillar. This is the business of biotech and on today's episode we're getting to know Romain a bit. Follow his biotech odyssey and we'll learn about the work he's doing to lead combined therapeutics through the white hot mRNA vaccine and therapeutic space. Dr Micol, welcome to the show and thanks for joining us.
Romain Micol, M.D.:Hello Matt. Thank you very much. It's nice to speak with you today. Thank you again.
Matt Pillar:Oh, it's great to speak with you too and I make this sort of joke about your academic accolades reading like alphabet soup, but it's a joke that I mean in a good hearted manner. I tell my kids all the time Roman. I tell them all the time academic achievement and accolades equate to optionality. They give you optionality further down the road in life. So I'm curious I want to start there because I'm curious about whether you considered yourself a degree, an accolade collector, or if you were looking for optionality, or if there was a method to your I guess your academic strategy.
Romain Micol, M.D.:Yeah, I think there is certainly some strategy in that academic but I'm passionate and I guess I started with my medical degree and specialization in infectious diseases and I think the PhD bring you a lot of serious in terms of science when you want to manage a biotech company. And yes, and the optionality to learn about finance during the MBA is also a great tool to raise capital and manage also safely your company with different finance and planning tool. And I think a degree that was very, very nice and helped me a lot to manage combined therapeutics it was the LLM at the London School of Economics to better understand intellectual property. So it's a very, very interesting area to learn when you want to manage your business in the biotech field.
Matt Pillar:Yeah, yeah, for sure. I'm curious about your the transition from academia and practicing medicine to the business side of biotechnology what was your first foray into? Like you said, that LLM degree benefited, the MBA sort of set you up in some ways from an academic perspective for biotech business leadership. What was the, I guess, motivation to move away from academia and practicing medicine into the business side?
Romain Micol, M.D.:Yeah, so I had a transition in a pharma company to learn about pharma company and how to participate to R&D program and then integrating the business development unit of that company. And that transition I made was particularly also to learn working at the international level and I had the opportunity to learn, to work and learn from different countries such as USA, india and China, and then I think I got really the passion and entrepreneurship to develop my own companies with a particular, a very great co-founder.
Matt Pillar:What was the hardest part about that transition, moving from sort of an academic approach to medicine to the business part?
Romain Micol, M.D.:Well, I think the hardest part was really to stop practicing medicine and seeing patients, because that's something I love. But it's a second life, new challenges, and that's very exciting too.
Matt Pillar:Yeah, what were some of the things like? If you were going to advise people who are sort of in that same position right, like transitioning from academic careers or practicing careers into the business side, what advice would you give them in terms of making that adaptation?
Romain Micol, M.D.:One of them. For my view and my personal view, one of the most important advice would be to keep your passion, to keep your wish to bring to the patient better treatment to improve their quality of life, and that's something that drives my personal development when I was practicing in hospital and I kept that same goal in terms of achievement for others when I started. Comitherapetix is to bring to population a better vaccine, to bring to cancer patients better immunotherapy to treat their cancer, and that's what has driven my excitation to start a new business. And I think when you keep as the main objective to bring to bring better medicines to the patient, to the population, you always federate investors and keep people to work with you.
Matt Pillar:Yeah, it's, and I'm going to ask you some questions about the formation of ComiTheraPetix here in just a minute. But one more stop on your career journey that I want to dig into a little bit. Like I said, like I said from the outset, like I wondered if this you know, this unique mix of degrees was strategic. Another stop on your career journey that I wonder if it was strategic was while you were at Transgene. You were there from 2010 to 2015. And you made the move from an international scientific program manager to director of business development and when you look at that I mean when you look at that on paper, you're like, well, that's quite a switch. So tell me about why you made that move into BizDev and how it helped you.
Romain Micol, M.D.:Yeah, it was a very great opportunity from the company and for me that the company gave me to transition from a scientific and IRMD position to a biddy marketing activities and position. But it was very, very helpful for me to understand how for my future business, by the way how the IRMD transition to a biddy to a product development, because that's not the same, absolutely not the same work and that's not the same challenges. So it was very, very exciting to transition from science to the marketing and the business and that experience was very important for me to better start combine therapeutics in 2016.
Matt Pillar:Yeah, I can only imagine that when you started, combine therapeutics coming into it with sort of that whole brain approach is an advantage. I think there are a lot of scientific founders who may lack some of that you know, market facing kind of business experience, so I can see where that would be advantageous. So maybe the takeaway is for the you know, the scientific listeners among our audience to consider a biddy role at least for a little while, to gain that experience.
Romain Micol, M.D.:Yeah, yeah, absolutely that's very powerful.
Matt Pillar:Yeah, All right, so combined. Tell us the origin story. How did you come to co-found this company with Robert Langer and Dan Anderson back in?
Romain Micol, M.D.:2016? Yeah, so the story of combine therapeutics in 2016 was to potentially, because it was really a vision at that time, without any scientific proof of concept to offer potentially to the patient some therapeutic mRNA that will announce I don't want to enter too much in the scientific detail, but that will announce some viral therapy. You know, viral therapy is like a virus that attacked the tumor and we at that time we were expecting, hoping to develop therapeutic mRNA to announce the virus that will attack the cancer, to have better viral therapy and immunotherapy products to treat cancer patients. That's the story of combine therapeutics and we achieved in 2019 great proof of concept. And then the company because that's the business also of any biotech company to potentially evolve and change their objectives.
Romain Micol, M.D.:The idea I did as CEO of combine therapeutics to apply what we learned from viral therapy and cancer to potentially develop better mRNA vaccine. And then the company has changed. The board has been got some new board member and we decided to launch an activity around mRNA vaccine and we, what we learned sorry, I'm repeating myself what we learned from the cancer treatment for viral therapy on quality values has been applied, a similar approach to the vaccine. It's totally two different worlds. There is no connection. But when you success in one domain, and particularly in an emerging biotech, and you believe that your team will accomplish a similar level of success in another field that is completely booming and that's the mRNA vaccine, in 2020, with the COVID-19 pandemic, you have to try when you are CEO, and it's what we try at Command Therapeutics, and the team has successfully developed a new generation of mRNA vaccine for infectious diseases and for cancer and we are now moving from clinical development to clinical development next year.
Matt Pillar:Yeah, but just to clarify I want to make sure that I'm tracking correctly here your mRNA work began pre-COVID pandemic, correct?
Romain Micol, M.D.:Yeah, pre-covid pandemic, pre-covid pandemic, Pre-COVID cancer with immunotherapy.
Matt Pillar:Yeah, there are a lot of startup companies that jumped on the mRNA bandwagon post-COVID pandemic for obvious reasons that we don't need to get into. So, throwing your mind back in time pre-COVID pandemic, give us a little more light, shed a little more light on why at that time before I mean, obviously we know mRNA therapeutics and vaccines were in development for a long time before the pandemic and that just really shown a bright spotlight on that space. But why was mRNA your platform of choice at that time, even before it began to prove itself in a meaningful way in the COVID?
Romain Micol, M.D.:era, so okay, so why we choose the mRNA platform in 2016? That's your question.
Matt Pillar:Yeah, yep, yeah, you simplified my you. May you simplified my question, but that's the heart of it.
Romain Micol, M.D.:yes, yeah, I mean, you know, we know that nucleic acid therapies are a very versatile platform and a lot of companies since a few decades try to work on DNA.
Romain Micol, M.D.:But DNA technology has some main challenge in terms of manufacturing stability and in terms also on potential integration in your genomes. So some companies in the early 20s and then in 2010, with Moderna BioNTech, transfect Bio, has developed the mRNA and as applied the knowledge the scientists has developed on DNA to the mRNA, with the particularity of the mRNA of course, and the reason is mRNA are much more easier to produce and it's changed everything, and certainly in terms of integration to your genome, there is much less risk with mRNA compared to DNA. So for safety, efficacy, manufacturing purpose, the mRNA, in terms of in the ombrilow nucleic acid therapy, was really the technology very attractive to develop, and that technology can also answer cancer treatment and vaccine and vaccine. So it has a huge versatility and that's the reason I think that the mRNA technology is a huge success today. Even there is room for improvement, as always in medicine. That's a great technology.
Matt Pillar:Therapies based on messenger RNA offer many manufacturing advantages over traditional biologics, including cost, speed and flexibility. On the Business of Biotech podcast, we delve into all things related to mRNA manufacturing, from making mRNA vaccines to their scale-up, regulatory approval and more. The pod is brought to you in collaboration with CITIVA, a global provider of technologies and services that advance and accelerate the development, manufacture and delivery of therapeutics, including mRNA production and manufacturing. Check out their resources at CITIVAcom. Backslash emerging biotech.
Matt Pillar:It occurs to me that a company that was playing in this space, doing good work in development in this space prior to the COVID pandemic and, as I said, sort of the onslaught of follow-on companies adopting mRNA as a platform I mean there are hundreds now globally of emerging companies that are working on mRNA therapeutic and vaccine development. I imagine, from your perspective, there had to come a point there where you went being sort of a veteran in the space, right, like a company that had been playing in the space for quite some time. There had to come a point where you're like oh boy, oh boy, here we go. Here comes the competition, here comes the crowd. Can I say competition not just from a therapeutic standpoint, from a fundraising standpoint and from a noise in the marketplace standpoint. So what are your thoughts there? When you saw this space balloon, the way that it has, yeah, I mean competition is good.
Romain Micol, M.D.:I think it's something that pushes you to develop and to assess your own challenges. So I think it's a good thing to have competition. Yes, I guess in terms of fundraising, it's certainly diluting the potential capacity to raise cash. At the end of the story, sophisticated investor invests according to the portfolio they have. They try to, they risk to diversify their portfolio. So when you have the good technology, that means you have generated good science and you have also a strong IP position. This is where the competition some competitor can lose the race.
Matt Pillar:Yeah, so tell us a little bit more about that, the, I guess, competitive differentiation at combined. What are you doing to distinguish yourself in this crowd?
Romain Micol, M.D.:So we have developed a unique technology at combined therapeutics, because a messenger RNA to simplify the discussion, the messenger RNA is delivered with a lip-pin nanoparticle. And today what we believe at combined therapeutics is the need to develop better vaccine based on an improved distribution and also based on an higher potential compared to the current mRNA vaccine, both for infectious diseases and cancer. To answer the better distribution profile, there is two, I would say two different approaches. The first one is to work on the excipient, that's the lip-pin nanoparticle that protects the mRNA. That's a lot of CDMO are trying to optimize or improve their lip-pin nanoparticle.
Romain Micol, M.D.:That's not what we are doing at combined. At combined, we are modifying the mRNA to allow the mRNA, or to have struck the mRNA, to produce the vaccine in some part of the body and, by definition, the muscle at the site of injection, and to inhibit the mRNA translation or the vaccine production in your periphery core gap. So currently the mRNA vaccine has a broad distribution, it's publicly available in formation and our technology is focusing purely on the mRNA vaccine part and the modification of the mRNA sequence and we have a strong IP position on that technology. It's where we are blocking competitors to enter in that domain of technology.
Matt Pillar:What does that mean in terms of the delivery vehicle? So are you saying your technology requires no LNP or doesn't require a no, no, no.
Romain Micol, M.D.:Our technology recryer, lnp, or our technology, I would say, can be used by any delivery particular. Okay, lipid polymer, whatever you want to use or to use as a delivery vehicle.
Matt Pillar:Yeah, are you tackling or facing? You mentioned that a lot of that is available in the outsourcing community. Just the other day, I interviewed a company that's solely dedicated to the development of delivery vehicles for nucleic acid therapeutics. At present, they've built a company on that and they don't even have a therapeutic molecule just yet.
Romain Micol, M.D.:Yeah, so the companies that develop new lipid nanoparticles to improve the distribution are not seeing those companies as competitors of combined biodegradable products. They are complementary approach. Potentially, if you want to reach almost 99% of the distribution success, you may want to combine new lipid and a great more sophisticated mRNA technology, and that's our vision. By the way, combined therapeutics we are working with our own mRNA technology, but we are also assessing the new lipid generation because we believe that together they will bring much more safer and with higher efficacy vaccine.
Matt Pillar:Yeah, how are you doing on time, dr Miquel, are you okay?
Romain Micol, M.D.:Yeah, yeah, okay, I think we can have a last or two last question.
Matt Pillar:Sure, yeah, all right. Good, give us an update, if you can, on the pipeline effort at combined. Where are you in terms of your lead candidate and any follow-ons?
Romain Micol, M.D.:Yeah, absolutely so. We have a pipeline of infectious disease vaccine and cancer vaccine. The good news for the companies we reached two months ago a very important milestone in terms of R&D and product development. That's the selection of our lead platform. That means we have selected the mRNA platform that will better be able to distribute the any vaccine infectious disease and cancer and also molecular adjuvant to improve the potency of the vaccine. So, in terms of pipeline, we are very pleased to start the manufacturing of our first lead candidates early next year, between the end of this year and early next year, and we have a pipeline including infectious disease vaccine and cancer vaccine, without molecular adjuvant to improve their efficacy.
Matt Pillar:Very good as you head into manufacturing there. You mentioned from the outset that mRNA presents some unique manufacturing challenges that your technology seeks to overcome. What challenges remain for you? What do you see as potential risk factors in the manufacturing process that still need to be overcome?
Romain Micol, M.D.:Yeah, that's a very good question. I think the landscape is changing rapidly. Probably you would ask me the question two or three years ago. What will be the challenge of the manufacturing? I may have answered the access to a great CDMO, currently the CDMO. I think it's what you can read in different journals. The CDMO are facing a decrease in terms of the demand because the current mRNA vaccines are less used post-pandemic than during the pandemic. Now I would say the challenge is ready to done select, with your own risk factors, depending to your company, the best CDMO to manufacture the drug product.
Matt Pillar:So it's a completely different paradigm in terms of CDMO selection, where a few years ago it was who's got capacity.
Romain Micol, M.D.:Absolutely the supply chain was the main risk factor how to access the repeat, how to manufacture the mRNA, the supply chain of the drug substance, the supply chain of the exepium were probably the main risk factor. Today it's really, I think, to access to the best CDMO that integrates everything, but it's not the access to the raw material that's really the risk factor is purely linked, I would say, to the capacity of the CDMO and the company combined to work together and they risk the execution of the program.
Matt Pillar:Any specific attributes of a CDMO that combined, looked or looks for.
Romain Micol, M.D.:To make sure you're checking those boxes, yeah, currently we are discussing with a few CDMO because we have started the process of done selection and I think one of the main challenge is to integrate a CDMO that may be able to achieve everything from the manufacturing of the mRNA through putting your vaccine in a vial and controlling everything, I would say, from A to Z, with, of course, the capacity to do the risk if something happened during that process. Yeah, very good. Instead of working with two, three, four different CDMO.
Matt Pillar:Yeah.
Romain Micol, M.D.:There is pro and cons for the two organizations. What was that? There is pro and cons for the two approaches.
Matt Pillar:Sure, yeah, yeah. Well, I know you're short on time, dr Miquel. I'm thankful for the time that you gave us. Super nice talking with you. We'd love to have you back when we have a little bit more time to dig into some of this stuff. But thank you. Thanks for joining us and sharing the update on combined Thank you, matt, have a nice day.
Matt Pillar:You too. So that's combined therapeutics. Co-founder president, ceo and director. Dr Romain Micol, I'm Matt Pillar. This is the business of biotech. We're produced by Bioprocess Online and Life Science Connect with support from Citeva, which offers a deep trove of resources for new and emerging biotechs at Citevacom backslash emerging biotech. Check that out. Check us out at bioprocessonlinecom, where you can subscribe to the podcast and its newsletter In the meantime. Thanks for listening.