HiFiBiO Therapeutics has entered into a partnership with South Korea-based ABL Bio to co-develop its SARS-CoV-2 neutralising antibody HFB30132A for the treatment of Covid-19.
HFB30132A is said to have been discovered, engineered, and developed in less than six months by the US-based HiFiBiO Therapeutics.
The company said that its partnership with ABL Bio will drive the development of the antibody by making use of their respective strengths in research and development, and also complementary market access.
HiFiBiO Therapeutics chief operating officer Jeff He said: “Bringing the program from discovery into the clinic in such a short period of time was only made possible through our collaborations with clinicians, CROs, contract development and manufacturing organizations, and other research institutes along the way.
“With this ABL partnership in place, we are now well-positioned to rapidly advance HFB30132A through clinical development.”
The US firm is focused on developing immunotherapy by combining its single-cell profiling technologies with advanced data intelligence and expertise in immune system biology.
On the other hand, ABL Bio is engaged in developing antibody therapeutics for immuno-oncology and neurodegenerative diseases.
HiFiBiO Therapeutics has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) in August for HFB30132A. In the coming months, the company is looking to undertake a phase 1 single-IV administration ascending dose study in the US to evaluate the safety, tolerability, and pharmacokinetics in healthy volunteers.
The phase I trial will be followed by global late-stage clinical trials in Covid-19 patients later this year, said the company.
ABL Bio CEO Sang Hoon Lee said: “It will take a global effort to end the worldwide coronavirus pandemic.
“Together with HiFiBiO, we plan to accelerate program development to bring a safe and effective treatment to the world as soon as possible.”
According to the US company, HFB30132A and the SARS-CoV-2 viral spike protein bind with high affinity. The antibody is said have shown potent neutralisation of live virus infections in vitro and in vivo, which includes the D614G mutant, said the company.
Compared to traditional therapeutic monoclonal antibodies, HFB30132A, based on its preclinical results, is anticipated to have lesser possible adverse events and also higher distribution to lung and mucosal tissues.