A year and a half ago, the disease targeted by RenBio's lead asset did not even exist in humans, but now the upstart biotech is emerging with a COVID-19 antibody hopeful and $24 million in financing to go up against Big Pharma in the battle for a variant-busting treatment.
The New York City-based biotech announced a licensing agreement with Columbia University for the novel bispecific antibody, RB-100, and a $24 million series A today. RenBio secures global development and commercialization rights and Columbia snags an equity stake as part of the deal. Ruentex Group led the series A.
RenBio now has the exclusive rights and a cash infusion to advance RB-100 for COVID-19 into the clinic after the therapy demonstrated “robust antiviral activity” against the U.K., South Africa, Brazil, California and New York City variants in preclinical studies.
“Our goal is to be in the clinic by the end of this year,” said Neal Padte, Ph.D., chief operating and development officer, in an interview.
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RenBio expects that RB-100, which targets two distinct sites on the spike of the SARS-CoV-2 virus that causes COVID-19, will fit the criteria to be eligible for an emergency use authorization from the FDA, according to Padte.
The emergence of SARS-CoV-2 variants and the previous monoclonal-driven approach to COVID-19 antibodies is what drove RenBio to ink the deal with Columbia, said Rachel Liberatore, Ph.D., director of R&D, in a joint interview with Padte.
“There was a need really for a new generation of therapeutics to address these variants, and the data have largely supported the strategy of a cocktail-like approach, and so this bispecific molecule is really part of that type of strategy,” Liberatore said. “We think that the original concept of monoclonal antibody therapy as single agents is probably largely outdated in light of variants."
Eli Lilly certainly found this out the hard way last month when the FDA revoked single use emergency authorization of the drugmaker's monoclonal antibody bamlanivimab. Lilly had to go back to the drawing board, kicking off clinical development of a new antibody the company is hoping will be more effective against the newer strains.
Regeneron, which has an authorized antibody combo treatment called Regen-Cov, told analysts that demand for the treatment will persist despite increased vaccination efforts globally.
On Monday, Swiss biotech Memo Therapeutics joined the antibody crowd in announcing promising preclinical results for MTX-COVAB, which is being prepared for clinical trials.
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The RB-100 antibody will target mild-to-moderate patients, before severe disease onset, which is in line with other antibody molecules, Liberatore said.
RenBio actually originated from the HIV field. Liberatore pointed to the work of co-founder David Ho, M.D., Columbia University professor of medicine and founding scientific director of the Aaron Diamond AIDS Research Center. The company has broadened from anti-HIV antibodies to look at other infectious diseases, such as influenza and COVID-19, and will look at a number of cancer and inflammatory indications, Liberatore said. The goal is to bring a lead candidate into the clinic within two years, according to the funding announcement.
Founded in 2016, RenBio previously raised $4 million in a seed round, Padte said. Other non-dilutive financing previously came from the Defense Advanced Research Projects Agency, the Bill and Melinda Gates Foundation and AstraZeneca’s MedImmune.
Aside from the COVID-19 antibody, RenBio will also deploy fresh funds on continued development of its proprietary antibody delivery platform, MYO Technology.
“That was our initial technology that really was the foundation for the formation of the company,” Liberatore said. “It’s a nucleic acid-based antibody delivery platform, and it originated to address the need for affordable antibody therapeutics and prophylactics.”