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

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.”

HiFiBiO plans to begin a single ascending dose (SAD) Phase 1 clinical study in a healthy volunteer cohort, followed by a multiple ascending dose (MAD) study in patients with selected inflammatory and immunology diseases identified through the HiFiBiO DIS® platform.

HFB200604
HFB200604 is a best-in-class BTLA agonist monoclonal antibody designed to suppress activated T and B cells. Preclinical studies have shown that HFB200604 effectively inhibits T and B cell activation and demonstrated in vivo activities in a mouse model.

About HiFiBiO Therapeutics

HiFiBiO Therapeutics is a clinical-stage biotech driving a robust clinical pipeline of transformative immunotherapies targeting cancer and autoimmune diseases. HiFiBiO achieves an unprecedented understanding of immune modulation in human diseases by pioneering a unique high-resolution translational platform, Drug Intelligence Science (DIS®), which combines unique single-cell capabilities with AI/ML approaches. Using patient samples, DIS® enables the discovery of novel targets, effective antibody drugs, and predictive biomarkers to enhance the probability of success for immunotherapies. Moreover, HiFiBiO has established partnerships with major multinational pharmaceutical and biotech companies and has been recognized as one of the 2023 Fierce 15 biotech companies. For additional information, please visit www.hifibio.com

HiFiBiO® is a trademark of HiFiBiO Therapeutics and its affiliates