A third Long Island company has jumped into the global race to produce COVID-19 vaccines.
Hauppauge-based Covaxx, a spinout of United Biomedical Inc., has begun testing its lead vaccine candidate, UB-612, in a Phase 1 human trial in Taiwan. Further trials are planned for Nebraska and Brazil pending regulatory approval.
Closely held Covaxx joins Farmingdale-based Codagenix Inc. and Stony Brook-based Applied DNA Sciences Inc. in developing vaccines designed to blunt the coronavirus pandemic.
The entry of Covaxx gives companies based on Long Island — with less than one 2,500th of global population — a role in creating three of the 193 international COVID-19 vaccine candidates tracked by the World Health Organization.
"It's [a lot] for one smaller biotech hub," said William Hanes, technology commercialization fellow at the Center for Biotechnology/Long Island Bioscience Hub at Stony Brook University.
Covaxx co-founder and co-chief executive Mei Mei Hu said vaccine production already has geared up at the United Biomedical facilities in Taiwan in anticipation of successful clinical trials.
Taiwan's Ministry of Health and Welfare is providing up to $15 million to fund Phase 1 and 2 trials, which began in late September.
The Phase 1 trial will study 60 healthy adults from ages 20 to 55 who will receive two doses of the vaccine 28 days apart.
The vaccine is designed to prompt the body to produce both specialized antibodies to fight the virus as well as T cells, which offer a broader immune response.
Privately held United Biomedical, also based in Hauppauge, was founded by Hu's mother, Chang Yi Wang. Wang is an immunologist and biochemist who chairs 37-year-old UBI, which has facilities in Dallas, Taiwan and China.
UBI's vaccine design uses synthetic peptides — chains of amino acids — designed to mimic parts of the virus and provoke an immune response.
Covaxx has signed agreements with the University of Nebraska Medical Center and Brazil's DASA S.A. hospital group to conduct further human trials on the compound.
If the trials are successful, DASA would receive 10 million doses for Brazil's private market and 50 million doses for the public health market.
Covaxx aims to produce 100 million doses of the vaccine — which can be mass produced and does not need to be stored at the ultra-low temperatures required by some competitors — by the end of 2021's first quarter, Hu said.
"It's been going at COVID speed," Hu said of the vaccine's development. "It's a race to actually deliver it to patients."
As with Covaxx, the vaccine candidate of Codagenix already is in production in anticipation of successful trials. That vaccine, based on a live virus whose genetic code is scrambled, is being manufactured by Pune-based Serum Institute of India Pvt. Ltd., which is helping to fund the program.
Applied DNA Sciences has not announced human trials, but plans to test its lead human COVID-19 compound on cats. That data on a potential feline vaccine also could be used to advance a future human trial.
Applied DNA is developing the DNA-based vaccine with Rome-based Takis Biotech and Takis' animal health spinout, Evvivax.
Covaxx, incorporated as C19 Corp. in March, is led by Hu and her husband, co-founder and co-CEO Louis Reese. Reese, a former investment banker at J.P. Morgan, also is chairman of another UBI offshoot, Vaxxinity (formerly known as United Neuroscience).
The couple, part time Colorado residents, gained attention in March when they offered free UBI-developed COVID-19 antibody tests to the roughly 8,000 residents of that state's San Miguel County, home of the Telluride ski resort.
Co-founder and vice chairman of Covaxx is Dr. Peter Diamandis, founder and executive chairman of the X Prize Foundation, a nonprofit that hosts incentive competitions designed to benefit humanity. One current competition offers $5 million to anyone who can develop a cheap, fast and simple COVID-19 test.
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