HiFiBiO Therapeutics, a multinational biotherapeutics company focused on the development of novel antibodies for immunomodulation, announced the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for a novel SARS-CoV-2 neutralizing antibody for the treatment of Covid-19 patients.

The highly differentiated antibody, HFB30132A, has been rapidly identified, engineered, and evaluated in multiple preclinical studies. A Phase I single-IV administration ascending dose study will assess the safety, tolerability, and pharmacokinetics of HFB30132A in healthy volunteers.

HFB30132A is an anti-SARS-CoV-2 recombinant antibody engineered with specific sequences identified from the B cells of a COVID-19 convalescent patient. The antibody binds the viral spike protein with high affinity and has demonstrated potent neutralization of live virus infections in vitro and in vivo.

The antibody also efficiently neutralizes a panel of mutated SARS-CoV-2 viral strains including the well described mutant D614G. HFB30132A is expected to have fewer potential adverse events and higher distribution to lung and mucosal tissues than traditional therapeutic monoclonal antibodies based on preclinical results obtained so far. HFB30132A is expected to function as a monotherapy, both to provide immediate defense against an active infection and to proactively prevent one. This novel antibody has demonstrated a longer half-life than non-engineered antibodies, which is expected to further prolong the period for therapeutic efficacy or prophylactic protection.

“HFB30132A has the potential to bridge the gap between an antiviral therapeutic and a vaccine to help control the spread, limit immunologic symptoms and protect high-risk individuals,” said Mohammed Asmal, MD, PhD, Medical Advisor, and Infectious Disease Physician. “Most vaccines will require boosting to achieve effective levels of neutralizing antibodies. With its predicted long half-life in humans and high potency, HFB30132A can act as an interim layer of defense and be co-administered with other agents to provide even greater protection to patients in need.”

“HFB30132A is another great example of how teams from multiple locations of HiFiBiO Therapeutics have been able to collaborate with various partners and leverage our cutting-edge technologies and expertise to address clear unmet medical needs around the world,” said Francisco Adrian, PhD, Senior Vice President and Head of Research at HiFiBiO Therapeutics.

“Our innovative single-cell technology and deep understanding of the molecular mechanisms of SARS-CoV-2 infection enabled us to discover and develop this effective neutralizing antibody in less than six months. With this IND filing, we are now one step closer to delivering a breakthrough COVID-19 therapy to patients who need it most.”