A global vaccine manufacturer has begun producing the COVID-19 vaccine candidate of Long Island-based Codagenix Inc. even before it begins its Phase 1 human clinical trials in the U.K.
Farmingdale-based Codagenix has completed preclinical animal studies of its CDX-005 vaccine candidate and expects to begin Phase 1 human clinical trials by year's end.
"Currently, there are no licensed vaccines for COVID-19," Codagenix chief executive J. Robert Coleman said in a statement Tuesday. "Given the scale of the pandemic — more than 28 million confirmed cases worldwide and more than 900,000 deaths — the normal development process of waiting until after a vaccine has been proven effective to begin manufacturing wastes precious time."
Coleman said that preclinical testing of a single dose in animals administered through the nose has yielded positive indications of safety and effectiveness.
The World Health Organization lists 38 vaccine candidates worldwide that have advanced to clinical trials and 149, including the one made by Codagenix and the Serum Institute, at the preclinical stage.
Also listed among the preclinical candidates is a vaccine made by Stony Brook-based Applied DNA Sciences Inc. and its Rome-based partner, Takis Biotech.
While many of the other candidates in advanced testing seek to generate immune responses by using inactivated virus or genetic material, Codagenix seeks to generate a more vigorous response by using live virus whose genome has been scrambled by using software to add mutations.
That approach prompts the body to generate an immune response "that mimics that of the wild-type virus," Coleman said.
Codagenix, based at the Broad Hollow Bioscience Park, is backed by Manhattan-based Adjuvant Capital and Roslyn-based Topspin Partners.
"The COVID-19 pandemic has highlighted the need for a paradigm shift in the development of vaccines," said Glenn Rockman, Adjuvant's managing partner. "The software-driven virus recoding approach used by Codagenix holds the potential to not only develop optimized, more affordable versions of existing vaccines, but also rapidly respond to future outbreaks."
The Serum Institute of India, based in Pune, is one of the world's largest vaccine manufacturers by number of doses produced.
The Serum Institute also has begun manufacturing a vaccine candidate developed by AstraZeneca and the University of Oxford that is in advanced human trials.
But earlier this month AstraZeneca, based in Cambridge, U.K., suspended global trials of the vaccine after the unexplained neurological illness of a clinical trial participant.
Initially, AstraZeneca suspended clinical trials around the world before resuming them in some markets.
Codagenix previously announced that its Phase 1 trial would use about 50 paid young adult volunteers and be conducted in London by a unit of Dublin-based Open Orphan plc.
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