HiFiBiO Therapeutics Gets FDA Approval for IND of BTLA Agonist Antibody HFB200604

On November 4, 2024, HiFiBiO Therapeutics, a biotechnology company based in Cambridge, MA, USA, announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for HFB200604. This therapy is a BTLA agonist monoclonal antibody designed to address immune modulation in inflammatory and immunologic diseases. Developed through HiFiBiO’s proprietary Drug Intelligence Science (DIS®) platform, HFB200604 aims to restore immune tolerance by stimulating BTLA signaling in immune cells.

Liang Schweizer, Ph.D., the Founder, Chairperson, and CEO of HiFiBiO Therapeutics, expressed enthusiasm about the advancement of their first autoimmune program into clinical development. Dr. Schweizer emphasized HiFiBiO's innovative approach to translating patient insights into effective therapies, aiming to improve response rates in inflammatory and immunologic conditions.

Francisco Adrian, Ph.D., the Chief Scientific Officer of HiFiBiO Therapeutics, highlighted the potential of HFB200604 to benefit patients with inflammatory and immunologic diseases. Adrian noted that preclinical data suggest BTLA agonism could greatly reduce immune activation, and they anticipate translating these findings into significant clinical results.

HiFiBiO plans to initiate a single ascending dose (SAD) Phase 1 clinical trial involving healthy volunteers. This will be followed by a multiple ascending dose (MAD) study targeting patients with specific inflammatory and immunologic conditions identified through the DIS® platform.

HFB200604 is recognized as a top-tier BTLA agonist monoclonal antibody because it effectively suppresses activated T and B cells. Preclinical studies demonstrated that HFB200604 significantly inhibits T and B cell activation and shows promising effects in a mouse model.

HiFiBiO Therapeutics is a clinical-stage biotechnology company with a strong pipeline of transformative immunotherapies targeting cancer and autoimmune diseases. The company leverages its unique Drug Intelligence Science (DIS®) platform, which integrates single-cell capabilities with advanced AI/ML approaches, to gain deep insights into immune modulation in human diseases. By analyzing patient samples, DIS® facilitates the discovery of new targets, the development of effective antibody drugs, and the identification of predictive biomarkers, thereby enhancing the success rates of immunotherapies.

Additionally, HiFiBiO has established partnerships with leading multinational pharmaceutical and biotech companies and has been recognized as one of the 2023 Fierce 15 biotech companies.