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Human trials start on COVID-19 vaccine candidate from LI's Codagenix

Steffen Mueller, co-founder, president and chief scientific officer

Steffen Mueller, co-founder, president and chief scientific officer of Codagenix, works in the lab in Farmingdale in 2016.   Credit: Newsday/J. Conrad Williams Jr.

Codagenix Inc. has launched the first human trials of its COVID-19 vaccine candidate in the hope of bringing it to market in early 2022, an executive said.

Jeffrey Fu, chief business officer at the Farmingdale startup, said that the first doses in the double-blind, placebo-controlled study in London were administered to volunteers this month.

For every three participants who receive the vaccine, one will get a placebo. The 48 volunteers range from 18 to 30 years old and neither they nor the researchers know who received the placebo.

"The real objective of the phase 1 study is to demonstrate safety," Fu said, and initial results are promising, with "no risk signals" among the first three participants.

The study also will check the volunteers for indications that the vaccine is activating an immune response against the virus.

Phase 2 trials, involving a few hundred participants, would determine dosage levels for the virus particles in the vaccine.

Though Codagenix's vaccine, COVI-VAC, would reach market after those from Moderna, Pfizer-BioNTech and others, Fu said the Long Island product, if approved, could have competitive advantages.

Single dose via nose

Unlike the first vaccines to reach the market, COVI-VAC is expected to require a single dose administered with a dropper through the nose, eliminating the need for syringes, a second shot and medical technicians trained in inoculations, Fu said.

The Codagenix product can be stored in a standard freezer as opposed to the extreme cold of between -112 and -76 Fahrenheit required for the Pfizer-BioNTech vaccine.

Citing an online conference of the World Health Organization last week, Fu said that "the overwhelming sentiment is that we need more vaccines and we need second generation vaccines."

"The world needs multiple vaccines that work in different populations," Mike Levine, director of the Center for Vaccine Development at the University of Maryland, said at the WHO meeting of more than 2,800 scientists worldwide. "Ideally, those will be single-dose vaccines that do not require cold chain, could be delivered without a needle and syringe and are amenable to large-scale manufacture."

Fu said that Codagenix's vaccine, which is made with a disabled version of the live virus, potentially could invoke a stronger and longer-lasting immune response than current vaccines that focus on the distinctive spike protein in COVID-19.

"We hope that provides some additional degree of cross protection against other variant strains," such as those that have been reported in the United Kingdom and other regions, Fu said.

Based at Farmingdale State College

Codagenix, with 13 employees, is based at the Broad Hollow Bioscience Park on the campus of Farmingdale State College.

The Serum Institute of India is supplying financial support for the company's vaccine development. If the vaccine clears clinical trials and passes muster with regulators, the companies will share global marketing rights, with Codagenix taking the lead in some countries and the Serum Institute in others.

Serum Institute has agreed to produce 100 million doses of COVI-VAC in 2021 after receiving approval from regulators in India for large-scale trials and in preparation for global vaccine demand.

Fu joined Codagenix in October after nearly 30 years at pharmaceuticals giant Merck & Co., where he led global vaccine business development.

Codagenix was spun out of Stony Brook University. The company's funders include Accelerate Long Island, a not-for-profit, and venture capital firms Topspin Partners, Jove Equity, Adjuvant Capital, and Euclidean Capital.

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