ABL Bio, HiFiBiO Therapeutics partner for COVID-19 treatment

By Nam Hyun-woo

ABL Bio

ABL Bio said Monday it has signed a partnership agreement with multinational drug maker, HiFiBiO Therapeutics, on the development of a novel neutralizing antibody treatment for COVID-19.

According to the Korean biotech company, the two sides submitted an investigational new drug application to the U.S. Food and Drug Administration (FDA) on Aug. 25, and will soon finalize the terms of their agreement to produce the treatment by mid-2021.

The candidate, ABL901, is an anti-SARS-CoV-2 antibody engineered with specific sequences identified from the B cells of COVID-19 convalescent patients. Due to its extended half-life, the antibody is anticipated to effectively treat patients who have contracted the disease, while also being used as a preventative measure for people who have a high risk of exposure to the virus, such as healthcare workers, ABL Bio said.

ABL Bio and HiFiBiO expect to initiate early clinical trials in the U.S. within this month, estimated to take up to one month. Late-stage trials will follow with a goal of wrapping them up in April 2021.

The companies plan to accelerate the development process under the FDA Coronavirus Treatment Acceleration Program. A global contract manufacturing organization is contracted for the manufacturing of the antibody so that a global supply can be ready for distribution at the same time the clinical trials are completed, the companies said.

“It takes a global effort to end the worldwide coronavirus pandemic,” ABL Bio CEO Lee Sang-hoon said. “We hope to bring a safe and effective treatment to the world as soon as possible, to provide a better life amid this unprecedented situation.”

Established in 2016, ABL Bio is a Korean biotech firm developing antibody therapeutics for immuno-oncology and neurodegenerative diseases. HiFiBiO Therapeutics is a multinational biotech based in France, the U.S., China and Hong Kong, focusing on immunotherapy.