First in Human Episode #36 featuring Romain Micol

Romain Micol, co-founder of Romanian CBD therapeutics.

For Episode 36, we chat with Romain Micol, CEO & Co-Founder of Combined Therapeutics. Stay tuned to learn how Combined Therapeutics is developing unique mRNA-based treatments to better protect the world from infectious disease and cancer. First In Human is a biotech-focused podcast that interviews industry leaders and investors to learn about their journey to in-human clinical trials. Presented by Vial, a tech-enabled CRO, hosted by Simon Burns, CEO & Co-Founder. Episodes launch weekly on Tuesdays.

Rich McCormick, Jr.: [00:00:00] My name is Rich McCormick I’m the Executive Vice President of Clinical Strategy here at Vial. Today, I have the pleasure of welcoming Romaine Michael, CEO and co-founder of Combined Therapeutics to First In Human. Welcome, romaine.

Romain Micol: Thank you very much, Rich. It’s a great opportunity for Combined Therapeutics.

Rich McCormick, Jr.: Romaine, would you mind telling us a little bit about yourself and your background? 

Romain Micol: I’m a medical doctor specialized in infectious diseases. I’ve also got a PhD in communicable diseases. I have been through my medical degree internship in France. I worked in-hospital, in the primary immunodeficient department to take care of infants and newborns that presented with genetic diseases defecting their immune response.

And then, I took a new route in my career, joining the industry sector. I spent several years in the USA, China, and India to develop a vaccine and treatment for cancer. In 2016 and 2017, I started Combined Therapeutics, setting up the company in the USA. 

Rich McCormick, Jr.: Impressive background. What inspired you to start Combined Therapeutics? How did you develop the idea for your modified messenger RNA platform? 

Romain Micol: We started the company six years ago, with an expert from MIT, with the vision to modulate the protein expression in some tissue. We started Combined Therapeutics to improve cancer treatment and to develop a new technology to target the tumor cells to produce a treatment that will kill the cells themselves, sparing the tissue. I would be very pleased to follow up during the interview on our new development for our vaccine platform.

Rich McCormick, Jr.: That’s great. Can you tell us a little bit more about the multi-organ protective microRNA sequences that are key to your platform? 

Romain Micol: Yes, absolutely. That’s a huge challenge to have developed the multi-organ protection technology at Combined Therapeutics. There are millions of cells in the body. Each cell presents a specific microRNA. What we have developed has given a property to the MRNA, the messenger RNA, the code for a protein to bind to different microRNA to inhibit the protein expression in some tissue.

For example, in the liver, there is a very well known microRNA called microRNA122. When you design the binding sequence in the MOP construct of Combined Therapeutics that bind to that microRNA after an mRNA injection through IVR, even through IM for intramuscular injection for vaccine, the mRNA goes into the liver binding between microRNA122 and the binding sequence within the MOP inhibit the MR translation. 

It’s simple to explain, but it took several years for Combined Therapeutics to optimize that MOP platform. Now, we are able to deliver messenger RNA rendered through IM injection, also through IV to target cancer and spare the protein expression in more than six different organs. That’s a great achievement for vaccine development against infectious disease and cancer.

Rich McCormick, Jr.: Congratulations on that. You mentioned it taking a few years to develop so obviously there were some challenges along the way. Can you fill us in on how your team overcame some of those challenges? 

Romain Micol: Yes, the team at Command Therapeutics is driven by passion. We have identified unmet medical needs, particularly, where there is currently a gap between the technology, the treatment, and the vaccine. It has been a long and challenging process. The team has stayed focused. We have been persistent. It was one of the most important key drivers for the success of the company.

Rich McCormick, Jr.: Romain, can you tell us what infectious diseases you’re currently targeting with your messenger RNA platform and what led you to those decisions? 

Romain Micol: We have validated our mRNA -based vaccine platform at Combined Therapeutics. Meaning, we are able to deliver a messenger RNA through intramuscular injection. The mRNA is producing the vaccine located in the muscle. When the mRNA is going through the body in the different tissues, the mRNA transmission is inhibited. 

That platform could work for any infectious disease and for any concern. That’s a very important positioning of Combined Therapeutics. We have achieved several proof of concepts working on several different infectious diseases such as Covid 19. One of our most advanced models, but also other infectious diseases such as the virus cell infection.

We’re currently working on a program to develop a multivalent [00:05:00] MOP vaccine using also our adjuvant portfolio based on natural mNRA code for natural protein locally to improve the vaccine immunogenicity and efficacy particularly in vulnerable populations. It’s a key health challenge we would like to address improving the mRNA vaccine efficacy in vulnerable populations.

Rich McCormick, Jr.: Interesting. How does Combined Therapeutics, as a company, benefit from partnerships and collaborations? How does your team go about vetting those partners and establishing them? 

Romain Micol: We have a tremendous team at Combined Therapeutics. We have very great internal, talented, scientists. With the vaccine platform and the several candidates we have developed, we are very lucky, pleased, and happy to partner with Boston Children’s Hospital at Harvard Medical School that has a huge expertise in developing, and assessing vaccine efficacy at the preclinical stage, but also the clinical stage. That will be a very great partner for Combined Therapeutics to start phase one clinical triage as soon as we have successfully manufactured our first mRNA vaccine candidates. 

Rich McCormick, Jr.: What role do you see your messenger RNA-based therapies playing in the future for cancer treatment? How do you feel Combined Therapeutics is aligned with that field?

Romain Micol: As I mentioned at the beginning of the interview, we started the company to treat cancer. To cure cancer. That is something Combined Therapeutics is willing to achieve. Our mRNA platform, currently, at Combined Therapeutics, has several applications, and has the potential to have other applications to treat cancer. 

One: we have the capacity to offer personalized cancer vaccine using our mRNA-based vaccine platform that would focus the protein expression to fight the cancer at the site of injection and with our portfolio adjournment, we will improve the CDA, the Cytotoxicity immune response against the cancer, allowing, the patient to have multiple doses with a better safety profile because of the MOP platform that localized focus, the protein expression at the site of injection. I’m speaking about the cancer vaccine application, of course.

Two: we are also able to increase the immunoresponse by modulating the tumoral microenvironment and particularly by delivering therapeutics messenger RNA through an intravenous route of administration. It’s a key challenge, and a huge unmet medical need to deliver therapeutic through an IV that will target the tumoral cells and treat the cancer and, of course spare, protect the healthy organ by the treatment because of the MOP technology of combined therapeutics 

Finally, we have also a designer of technology and work on our intellectual property position to offer to combine the messenger RNA technology with current immunotherapy such as CAR T therapy. And other immunotherapy to treat cancer, like viral therapy. We have a broad portfolio of possibilities, particularly we are focusing on certain strategic positions for Combined Therapeutics. The future is very important for the improvement of current messenger RNA treatments. 

Rich McCormick, Jr.: That’s exciting. Romaine, as someone that has successfully navigated the research space, what advice would you offer to aspiring entrepreneurs, scientists, and researchers, anyone at this point looking to develop their own innovative medical technologies like you have. 

Romain Micol: That’s a lovely question. Staying focused. Keeping the same level of passion is key from the beginning of any project or any new startup. We are all facing some challenges. We are facing failure and you have to work, focus, and never give up. 

Rich McCormick, Jr.: Romaine, thank you for your time today and meeting with us on First In Human. The Vial team wishes you and the Combined Therapeutics nothing but success.

Romain Micol: Thank you very much, Rich. It was a pleasure to talk to you today. 

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