IND for HFB30132A submitted to the Ministry of Health of the Russian Federation and clinical sites selected for a Phase I/II, randomized, double-blind, placebo-controlled, two-stage, multicenter study
CAMBRIDGE, Mass. – November 23, 2020 – HiFiBiO Therapeutics, a multinational biotherapeutics company with unique expertise in immune modulation and single cell science, today announced a partnership with Russian pharmaceutical company, Pharmsynthez PJSC (MOEX: LIFE), and Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry RAS (IBCh). 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.
“We are excited to partner with Pharmsynthez and leverage its expertise and resources to successfully develop and deliver this innovative therapy to patients in Russia,” said Jeff He, Chief Operating Officer of HiFiBiO Therapeutics. “This strategic partnership showcases our open innovation approach and the global collaboration required to rapidly address this pandemic.”
“We expect that HFB30132A will be able to provide a reliable level of protection for people infected with the virus, especially for those who have risk factors such as cardiovascular disease or weakened immunity,” said Kirill Mayorov, President of Pharmsynthez. “This antibody has the potential to help fight active infections and prevent a cascade of serious complications that we have seen around the world. Given the severity of the epidemiological situation, Pharmsynthez will do its best to integrate HFB30132A into the arsenal of Russian medicine once we receive regulatory approval.”
About PAO Pharmsynthez
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 (MS) and Epolong™ – long acting erythropoietin formulation with once a month dosing potential. Under national COVID19 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. For more information, please visit the company’s website at http://en.pharmsynthez.com.
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 and academic researchers. The company’s strong 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.
HiFiBiO Therapeutics and the HiFiBiO Therapeutics logo are trademarks of HiFiBiO and its affiliates.