Hoth Therapeutics Inc., of New York, and Voltron Therapeutics Inc. have formed a joint venture, Halovax, to develop a vaccine for COVID-19 that can be advanced to clinical testing.

The venture is based on a self-assembling vaccine (SAV) platform that can be focused against specific pathogen targets; the platform has been licensed by Voltron from Massachusetts General Hospital’s Vaccine and Immunotherapy Center (VIC). Proof-of-concept studies, funded by the U.S. Department of Defense, support the SAV’s ability to evoke immune responses to viruses. The SAV platform, also known as the Vaxcelerate platform, was developed for rapidly generating vaccines for emerging infectious diseases. It was originally tested for Lassa fever but is clearly equally applicable to COVID-19. The SAV can be put together rapidly, according to Mark Poznansky, director of VIC.

“It’s incredibly stable; it won’t fall apart,” he told BioWorld. “You can keep it at room temp for a year and it will still be active. It is also extremely adaptable and can be modified rapidly to track with a changing viral target.”

The Vaxcelerate SAV has two elements for combating the coronavirus: a fixed immune adjuvant and one variable element for immune targeting, offering advantages over other vaccine approaches that rely on combination chemical adjuvants. The SAV both activates an immune response while targeting it to specific viral proteins.

The vaccine, should it be successful, is also adaptable.

Mark Poznansky, director, Vaccine and Immunotherapy Center, Massachusetts General Hospital

“Let’s say COVID-19 changes to COVID-20. All you would need to do is change the warhead,” Poznansky said. “But we can’t worry about that right now. We have a massive problem currently, and we hope to cope with that to some extent.”

Poznansky said the project is perfectly positioned for a hot start since it had so much preclinical work already completed or in progress. The proof-of-concept data are in infectious diseases and oncology in four animal models. He said it would take three to six months to test the SAV’s efficacy in animal models, which is standard. The following steps would be to get into human trials and put an emergency IND package together.

“It’s an incredibly challenging time,” he said. “There are a lot of groups out there working on COVID-19. We’re just one, but I’m glad to be part of the diversified group.”

Vaxcelerate is the creation of Poznansky, who is an associate professor of medicine at Harvard Medical School, and Jeffrey Gelfand, a physician at Mass General and part time professor of medicine at Harvard Medical School. Gelfand has worked in the lab and the clinic for more than 40 years to research immunology, inflammation and infection. Poznansky is credited with discovering fugetaxis, the principle of immune-repulsion, which is the movement of immune cells away from an agent source. Poznansky will advise in early clinical research for the vaccine and, should it come to it, implement testing in the hospital.

The SAV research for Lassa fever is in the preclinical stage at the Vaccine and Immunotherapy Center. Identified in the late 1960s, the hemorrhagic fever is transmitted by rats and is found mostly in west Africa. Even after patients recover, Lassa has the ability to remain in bodily fluids.

In the SAV deal, Hoth will be granted the right to receive single-digit royalties from the sale of any products developed and will have the right to acquire up to a 30% equity interest in Halovax.

Hoth’s stock (NASDAQ:HOTH) gained 98 cents, or 35.2%, to close March 23 at $3.74.

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