Therapy Areas: Vaccines
HiFiBiO Therapeutics Inks Partnership with Pharmsynthez and IBCh for the Clinical Development and Commercialization of its SARS-CoV-2 Neutralizing Antibody in Russia
23 November 2020 - - US-based biotherapeutics company HiFiBiO Therapeutics has forged a partnership with Russian pharmaceutical company Pharmsynthez PJSC (MOEX: LIFE), and Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry RAS, the company said.

The partnership aims to advance HFB30132A, a SARS-CoV-2 neutralizing antibody for the treatment of COVID-19, through clinical development and commercial sale in Russia, pending approval from the Ministry of Health of the Russian Federation.

An IND has been submitted to the Ministry of Health and clinical sites have been selected for a Phase I/II study.

Per the agreement, Pharmsynthez will purchase HFB30132A for clinical trials in Russia.

Upon regulatory approval, Pharmsynthez will continue to commercialize the product as the exclusive partner of HiFiBiO Therapeutics in Russia.

HiFiBiO Therapeutics retains all rights and continues to develop and commercialize HFB30132A globally.

HiFiBiO has leveraged its expertise in immune modulation and single-cell science to rapidly discover, engineer, and develop HFB30132A in less than six months.

Additionally, the company is currently dosing the second cohort of healthy volunteers in a Phase I ascending dose study (NCT04590430) to assess the safety, tolerability and pharmacokinetics of HFB30132A.

This Phase I study will be followed by global phase II/III clinical trials in high-risk adults with asymptomatic or mild to moderate COVID-19.

Pharmsynthez (MOEX: LIFE) the Russian publicly listed biopharmaceutical company that specializes in the development, manufacture and distribution of biologicals and vaccines.

It offers various proprietary prescription medicines, such as Neovir, Segidrin, Fenazid for use in oncology, gynecology and infection diseases.

Pharmsynthez lead clinical stage product candidates includes Xemys-therapeutic vaccine for the treatment of multiple sclerosis and Epolong - long acting erythropoietin formulation with once a month dosing potential.

Under national COVID-19 initiative in partnership with Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry Pharmsynthez is developing a hybrid nanocomposite vaccine for prevention of SARS-CoV-2 infection based on proprietary delivery technology.

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.

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 and academic researchers.

The company's strong global footprint features cutting-edge laboratories on three continents, in Cambridge, Mass., Paris, Shanghai, and Hong Kong.
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