Dr. Rob Coleman - CEO of Intranasal COVID Vaccine Developer

Scientists at Codagenix have developed a synthetic biology platform that combines live-attenuated virus design with codon deoptimization technology (using an AI-aided algorithm) to engineer intranasal vaccines for a variety of diseases. The software is used to modify hundreds of sites of the wild-type target so codons produce the same amino acid sequence with lower translational efficiency and virulence.

As both vaccine efficacy and logistics become more and more important for COVID-19 boosters, Codagenix is collaborating with the World Health Organization to rapidly test and rollout its intranasal COVID-19 vaccine, CoviLiv, to countries without the cold-chain infrastructure to support vaccines administered via injection. Codagenix is also targeting intranasal vaccine development to boost mucosal immunity, an important part of individual protection against respiratory viruses like COVID-19.

DocWire News spoke with Dr. Rob Coleman, CEO of Codagenix, to speak more about the company and its innovative vaccine.

DocWire News: Provide us with some background on yourself, and your company, Codagenix.

Dr. Rob Coleman: Sure. Codagenix, I’m a co-founder, CEO of the company. Also, co-inventor of the core technology. Actually the core technology of using synthetic biology to design vaccines was part of my thesis work at Stony Brook University. I started a company with just two individuals or three founders, and now we’re 28, based both in New York and Cambridge, Massachusetts.

What is the company’s overall mission?

Yep, sure. Goal is to, everyone’s thinks they’re an expert at making vaccines. I think we can see some of the limitations of these current first generation COVID vaccines only making antibodies. The best kind of vaccines for humanity have been what are called live attenuated vaccines. These are weak versions of the virus you want to protect against. Our core mission is we’ve invented a new way to make live vaccines that can’t revert, that are safe, but give all the traditional benefits of live vaccines. We’ve actually developed a computer algorithm to redesign the DNA of any virus to convert it from killer pathogen into live attenuated vaccines. That’s our mission. We think there’s still a way to make better vaccines quickly, and we want to harness synthetic biology and then utilize the proven way we’ve always vaccinated pre-COVID, which was live attenuated. That’s our mission to solve infectious disease challenges using live vaccines that we think are safe and effective.

Are people beginning to underestimate the need for COVID vaccines?

Clearly the first generation vaccines were very good at preventing severe disease. I think what they’ve shown is what all of those vaccines are very similar in that they give you protein to make antibodies. They’ve shown that they can rapidly generate a vaccine that can prevent severe disease, maybe doesn’t prevent transmission. And so where we can insert ourselves is to actually… Our COVID vaccine’s an intranasal vaccine, also our RSV is. And so, there’s a place for maybe both technologies, those could be used for protect against severe disease, but ours can be used to actually make mucosal immunity to prevent transmission and prevent future variants. I don’t know sure if I answered your question, but I think there’s always a need for all kinds of vaccines because that can protect against disease. And I think Codagenix has a unique profile in that not only can we potentially protect against disease, but also protect against transmission, especially for respiratory viruses like COVID, RSV, flu.

Talk to us about Codagenix’s intranasal COVID-19 vaccine – how does it work, and how effective is it?

Sure. So we have two products, so for COVID, we’re in a phase three placebo controlled efficacy trial sponsored by the WHO, so this is incurring in over five countries now. We’re actually testing our vaccine versus those that individuals that receive placebo and seeing how efficacious our vaccine is against protecting against disease. What’s super unique about our product is it doesn’t require ultra freezer. It doesn’t require a needle. It can be stored in the fridge. It uses a dropper. And what we’ve been able to see in our earlier clinical trials was that while it did make antibodies, more importantly, it made very broad cellular and mucosal immunity that could protect against variants and even future variants. And so we think that our vaccine will offer a virus that provides a more holistic, if you will, immune response. Sounds a little bit cliche, but it’s true. It can make antibodies, it can make mucosal immunity, it can also make memory T-cells. And that’s what our offering is and differentiated.

What else does Codagenix currently have in the pipeline?

In the vaccine front is we are just about to start, everyone knows this past winter, not only was COVID bad, but also RSV was very bad, especially for children. So if you weren’t paying that close attention to RSV and you just looked at the news, very bad RSV season, Pfizer and GSK coming out with their phase three results. But the sub bullet there is the Pfizer GSK results are focused on the elderly, actually not focused on the six months to four year old population.

And so what’s unique about Codagenix is we have an intranasal vaccine specifically targeted for six month olds to five-year-olds. It’s intranasally delivered, it’s a live attenuated. And there’s actually very little competition in this space because it’s a challenging age group to make a vaccine for. And so we have an open IND from the FDA now, the FDA actually gave us fast track designation before we even started clinical development in that group, simply because there’s a urgent unmet need. So we could see last season, RSV was really bad. Who was it really bad for? Actually kids. Those were the ones with all the hospitalization. And there’s actually very few vaccine players trying to make a vaccine for this six month old to five-year-old population. And that’s exactly where Codagenix fits in.