HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200604, a Best-in-Class BTLA Agonist Antibody for the Treatment of Inflammatory and Immunology Diseases

Excerpt from the Press Release:

CAMBRIDGE, Mass.–(BUSINESS WIRE)–HiFiBiO Therapeutics, a clinical stage biotechnology company focused on immune modulation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for HFB200604. HFB200604 is a best-in-class BTLA agonist monoclonal antibody, developed using HiFiBiO’s proprietary Drug Intelligence Science (DIS®) platform. The therapy is designed to restore immune tolerance in inflammatory and immunology diseases by stimulating BTLA signaling in immune cells.

“HFB200604 represents our first autoimmune program to advance into clinical development, highlighting HiFiBiO’s innovative approach to rapidly translating patient insights into impactful therapies,” said Liang Schweizer, Ph.D., Founder, Chairperson, and CEO of HiFiBiO Therapeutics, “We are excited to leverage our DIS® platform to address the challenges of patient heterogeneity in inflammatory and immunology diseases, with the aim of achieving higher response rates.”

Francisco Adrian, Ph.D., CSO of HiFiBiO Therapeutics, added “We are thrilled to bring our best-in-class BTLA agonist HFB200604 to patients suffering from inflammatory and immunology diseases. Our single-cell immune profiling data suggest that BTLA agonism could be a highly effective approach to reducing immune activation, and we look forward to translating compelling preclinical findings into meaningful clinical outcomes.”

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