14 September 2020 - - Clinical-stage multinational biotherapeutics company HiFiBiO Therapeutics has forged a partnership agreement with South Korea-based ABL Bio to advance HFB30132A, a SARS-CoV-2 neutralizing antibody for the treatment of COVID-19 patients, the company said.

The two companies will join forces to drive the development of this innovative antibody by leveraging their unique R and D strengths and complementary market access.

HiFiBiO rapidly discovered, engineered and developed HFB30132A in less than six months.

The company submitted an Investigational New Drug application with the US Food and Drug Administration on August 25th and is planning a US Phase I single-IV administration ascending dose study to assess the safety, tolerability and pharmacokinetics in healthy volunteers in the coming months.

This Phase I study will be followed by global late-stage clinical trials in COVID-19 patients in late 2020.

HFB30132A binds the SARS-CoV-2 viral spike protein with high affinity and has demonstrated potent neutralization of live virus infections in vitro and in vivo, including the well-described mutant D614G.

Based on preclinical results, this antibody is expected to have fewer potential adverse events and higher distribution to lung and mucosal tissues than traditional therapeutic monoclonal antibodies.

Additionally, it has demonstrated a longer half-life than non-engineered antibodies. HFB30132A is currently positioned to function as a monotherapy, both to provide immediate defense against an active infection and to proactively prevent one.

HiFiBiO will continue to employ its open innovation approach beyond current collaborations to develop this promising antibody drug against COVID-19 as both mono and combination therapies.

ABL Bio, Inc., is a South Korean biotechnology company dedicated to developing antibody therapeutics for immuno-oncology and neurodegenerative diseases.

HiFiBiO Therapeutics' global footprint features laboratories in Cambridge, Mass., Paris, Shanghai and Hong Kong.