HFB30132A study design is published in ClinicalTrial.gov and primary data readout is expected in late 2020
CAMBRIDGE, Mass. – October 26, 2020 – HiFiBiO Therapeutics, a multinational biotherapeutics company with unique expertise in immune modulation and single-cell science, today announced the successful completion of the first cohort of the Phase I study (NCT04590430) of HFB30132A, a SARS-CoV-2 neutralizing antibody for the treatment and prevention of COVID-19.
This randomized, placebo-controlled, ascending dose study has been designed to assess the safety, tolerability, and pharmacokinetics (PK) of HFB30132A in 24 healthy volunteers.
A total of three cohorts will be dosed and evaluated at the Medpace Clinical Pharmacology Unit in Cincinnati, Ohio. All available safety, tolerability, and PK data for each cohort will be reviewed and evaluated by the Dose Escalation Committee. The second cohort will be dosed after the first cohort data is reviewed and the antibody is determined to be safe. To date, no adverse events have been observed.
“This Phase I study is a major milestone in HiFiBiO’s evolution from a pre-clinical organization to a clinical-stage company, and it takes us one step closer to addressing this critical pandemic situation around the world,” said Liang Schweizer, PhD, President and CEO of HiFiBiO Therapeutics. “The fact that we have rapidly advanced this antibody from discovery to the dose of the first Phase I cohort in just eight months is a great testament to the capabilities of our cutting-edge technology, our talented team, and our strategic partners around the world. We believe HFB30132A is uniquely positioned to treat patients early during infection, especially high-risk adults, to reduce instances of COVID-19 hospitalization and complications.”
“We are excited about the opportunity to collaborate with the HiFiBiO team on this novel therapy,” said Leela Vrishabhendra, MD, Senior Medical Director of Medpace Clinical Pharmacology Unit. “HFB30132A has the potential to provide a critical layer of defense for COVID-19 positive individuals, especially those with underlying risk factors, such as cardiovascular disease or compromised immune system. This antibody can help fight off an active infection and prevent a cascade of severe complications that we have been witnessing globally.”
Later this year, the Phase II/III study is planned to enroll high-risk adults with asymptomatic or mild to moderate COVID-19 to assess efficacy after the primary data readout demonstrates that HFB30132A can be safely administered.
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 infection in vitro and in vivo. The antibody extensively covers the interface between Spike protein and its receptor ACE2, and also efficiently neutralizes a panel of mutated SARS-CoV-2 pseudovirus strains, including the well-described mutant D614G. HFB30132A is expected to work as a monotherapy, both to provide immediate defense against an active infection and to proactively prevent one. Compared to conventional therapeutic monoclonal antibodies, HFB30132A is engineered to have an extended half-life and reduced Fc receptor functions that are expected to result in longer protection, fewer potential adverse events, and higher distribution to lung and mucosal tissue.
About HiFiBiO Therapeutics
HiFiBiO Therapeutics is transforming the field of immunotherapy by combining proprietary single-cell profiling technologies with advanced data intelligence and deep knowledge of immune system biology. This approach enables the development of novel antibody therapies that are paired with biomarkers to predict patient response. HiFiBiO Therapeutics is working actively to address unmet medical needs around the world through its own innovative pipeline programs and open-innovation partnerships with world-renowned industry leaders and academic researchers. The company’s global footprint features cutting-edge laboratories on three continents, in Cambridge, Mass., Paris, Shanghai, and Hong Kong. To learn more, please visit www.hifibio.com.
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