First in Human: Rising to COVID-19, Codagenix accelerates early-stage vaccine

This is a recurring column on clinical research in the early stages of development, which is referred to as phase 1. These are treatments being used for the first time in a small number of human patients to determine safety, dosing and general pharmacological activity.

In the realm of COVID-19 vaccines, there are household names like Pfizer Inc. and Moderna Inc., but early clinical trials from companies such as Codagenix Inc. have brought about a new wave of innovation that could help fight this pandemic and ones yet to come.

Codagenix's version is a live-attenuated vaccine — a weakened form that will not cause disease — that can be administered through the nose. What is different about the approach is that the company uses a computer algorithm to recode the genome of the virus by inserting hundreds of mutations. These mutations give the vaccine the potential to provide a broader immune response compared to other COVID-19 vaccines that target a portion of the virus such as the so-called spike protein.

"Commonly, when people think of a vaccine platform, they think of mRNA — they think of adenovirus which is literally carrying your payload," Codagenix CEO J. Robert Coleman told S&P Global Market Intelligence in an interview. "Our platform is actually a software that redesigns the genome of a virus, turning it from a killer virus, or the pathogenic version, into a benign vaccine."

The company began a phase 1 trial in London with the Serum Institute of India Pvt. Ltd. with 48 volunteers participating to test safety, tolerability and immunogenicity. The vaccine was shown to be safe in animal studies and does not require the same level of refrigeration as other vaccines.

Codagenix is targeting approval of the vaccine in India by the end of 2021, and the Serum Institute is committed to manufacturing at least 100 million doses by that time, Coleman said.

"Our product is very scalable so it doesn't require this ultra-frozen cold chain," Coleman said. "So the manufacturing is relatively straight forward."

Coleman said attenuated viruses are known to provide the broadest immunity with a single dose. They have been able to eradicate diseases like smallpox, but the Achilles heel for this type of vaccine has been how difficult they are to produce.

"There are ways that genes can be efficiently translated and there are ways genes can be inefficiently translated," Coleman said. "What our platform does is it creates de-optimized viruses, so it redesigns their genes for slower translation — we've hamstrung the virus where it's no longer pathogenic, but it still provides all the different proteins for immune response."

This approach to vaccine development can be used for other viruses. In particular, Codagenix has vaccine candidates for influenza and RSV in the clinic.

"It doesn't matter if it's flu, RSV, Dengue, Zika, COVID — they use the human host cell to translate themselves, to make a million copies of itself in eight hours," Coleman said. "They've optimized themselves to work really well in the human cell machinery."

The point of the phase 1 trial is to find the right dosing bracket for the vaccine as it moves forward in human trials, Coleman said.

"We don't make the decision to go to the next dose based solely on immunogenicity," Coleman said. "The whole point of a phase 1/2 is to bracket — this one is too hot, this one is too cold — and hopefully the one in the middle is the most safe."

The planning is in place for later-stage trials once the company identifies the correct dose from phase 1. The unprecedented speed of the trials is something that everyone in the industry has had to get used to, Coleman said.

"It's untraditional where you have to overlap your planning and you have to put capital at risk even while the first trial is going on," Coleman said. Codagenix has had conversations with the U.S. government and is looking at further development before continuing those regulatory talks.

Coleman said a second-generation vaccine in developed countries and a first-generation product in developing countries could be important to solving the worldwide pandemic.

"There are multiples of billions of individuals that need vaccines, so that means we could be the first vaccine that a person receives," Coleman said.