Farmingdale-Based Codagenix Testing Coronavirus Vaccine

FARMINGDALE, NY — Codagenix, a biotechnology firm based at the Broad Hollow Bioscience Park of Farmingdale State College, said it recently began testing its coronavirus vaccine candidate on people.

The firm and the Serum Institute of India said they launched a phase 1 trial involving 48 volunteers who will be administered three dosage levels to determine the vaccine's safety. Data from the trial is expected by mid-2021 and advanced clinical testing could begin soon after. If all goes well, the Codagenix vaccine could hit the market in 2022, according to a representative.

The first patient was given the vaccine, called COVI-VAC, last week. Codagenix CEO J. Robert Coleman said it was an important milestone, and he believes his company's vaccine has "significant" advantages over other coronavirus immunizations.

"As a live attenuated vaccine, COVI-VAC has the potential to provide a broader immune response in comparison to other COVID-19 vaccines that target only a portion of the virus," Coleman said in a statement. "This could prove critical as new variants of SARS-CoV-2 have begun to emerge."

COVI-VAC also has the potential to address several obstacles to global immunization against the coronavirus, according to Codagenix. The vaccine is a single dose administered with a dropper through one's nose; no needles are required. The vaccine could be manufactured at a large scale and can easily be administered with minimal training, he added.

"Given the scale and global breadth of the pandemic, multiple vaccines will be needed to ensure equitable access, and COVI-VAC holds great potential to help meet the global demand as a single dose, needle-free vaccine that needs only a standard freezer or fridge," Coleman said. "In addition, COVI-VAC is ideally suited for mass production using technologies already in place at global manufacturing facilities."

The phase 1 trial is a randomized, double-blinded, placebo-controlled dose-escalation study, the company said. The study will evaluate the vaccine's ability to provoke an immune response — measuring neutralizing antibodies, mucosal immunity in the airway and cellular immunity. The trial is being conducted by hVIVO, a subsidiary of Open Orphan, in London.

"Given the impressive efficacy signals from the vaccines that have already received emergency use authorization in the U.S., it's tempting to take your foot off the gas if you are developing a different vaccine construct for this terrible virus," said Charlie Petty, principal at Adjuvant Capital and a Codagenix board member, in a statement. "It may sound cliché, but the reality of this pandemic is that none of us is safe until all of us are safe — globally — and that will require billions of vaccines that can be easily delivered and administered. We are optimistic that COVI-VAC can play an important role in achieving equitable access to protection from SARS-CoV-2, and the Serum Institute of India is the ideal partner to achieve our large-scale distribution ambitions."

COVI-VAC was developed with Codagenix's Synthetic Attenuated Virus Engineering (SAVE) platform, which uses synthetic biology to re-code viruses' genes into safe and stable vaccines. The Codagenix vaccine is designed to deliver a safe, live-attenuated version of SARS-CoV-2, the virus that causes COVID-19, compared to other available vaccines.