HiFiBiO Therapeutics has entered into a partnership with Pharmsynthez and Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry RAS (IBCh) to develop and commercialise its SARS-CoV-2 neutralising antibody, HFB30132A, for Covid-19 treatment.
The anti-SARS-CoV-2 recombinant antibody HFB30132A is engineered with specific sequences identified from the B cells of a Covid-19 convalescent patient.
The partnership plans to advance the antibody through clinical development and commercial sale in Russia on getting approval from the Russian Federation health ministry.
HiFiBiO has submitted an Investigational New Drug (IND) to the ministry and selected sites for conducting Phase I / II study.
According to the deal, Pharmsynthez will purchase HFB30132A for clinical trials in Russia and continue to commercialise the product as the exclusive partner of HiFiBiO in Russia, after obtaining regulatory approval.
HiFiBiO will have all rights and develop and commercialise HFB30132A across the globe.
HiFiBiO Therapeutics chief operating officer Jeff He said: “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.
“This strategic partnership showcases our open innovation approach and the global collaboration required to rapidly address this pandemic.”
Using its knowledge in immune modulation and single-cell science, HiFiBiO discovered, engineered and developed HFB30132A in less than six months.
The company is currently dosing the second cohort of healthy volunteers in Phase I ascending dose study to evaluate the safety, tolerability and pharmacokinetics of the antibody.
This study will be followed by global Phase II / III trials in high-risk adults with asymptomatic or mild to moderate Covid-19.