HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200603

HFB200603 is a novel anti-BTLA Antibody for the treatment of DIS® Defined Solid Tumors

CAMBRIDGE, MA.– January 6, 2023 – HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company, announced today the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for HFB200603. HFB200603 is a novel monoclonal antibody against the immune checkpoint BTLA that blocks the interaction with its ligand, HVEM. HFB200603 is designed to reverse HVEM-mediated immune suppressive effects and induce the production of inflammatory cytokines in various solid tumors selected by HiFiBiO’s proprietary Drug Intelligence Science (DIS®) platform.

“The FDA’s clearance of our IND for HFB200603 marks our third consecutive successful IND for a therapeutic antibody targeting DIS® defined solid tumors”, said co-founder and CEO of HiFiBiO Therapeutics, Liang Schweizer, Ph.D. “This is continuing validation of the strength of our single cell-powered DIS® platform to identify and develop novel drugs.”

“We are excited to bring our BTLA clinical candidate HFB200603 to patients and translate the promising preclinical data obtained in our labs into meaningful clinical benefit” shared Francisco Adrián, Ph.D., CSO of HiFiBiO Therapeutics. “HFB200603 has demonstrated its ability to stimulate tumor infiltrating lymphocytes and to potentiate the immunomodulatory effects of PD-1 blockade in human tumor cultures from different cancer types.”

The planned Phase 1 clinical study will consist of an initial dose escalation followed by expansion cohorts, including combination treatment with Novartis’ Tislelizumab, in selected solid tumors identified through HiFiBiO DIS® platform.



HFB200603 was identified using HiFiBiO single cell platform as a single-digit nanomolar binder to human and cynomolgus BTLA, capable of blocking BTLA interaction with its ligand HVEM, reversing HVEM-mediated immune suppressive effects, and inducing the production of inflammatory cytokines in the tumor microenvironment of different human tumor types. HFB200603 synergizes with anti-PD-1  and demonstrates favorable developability, pharmacokinetic and safety profiles.

About HiFiBiO Therapeutics

HiFiBiO Therapeutics is a clinical stage biotech company advancing a robust pipeline targeting both the innate and adaptive immunity to treat cancer and autoimmune diseases. Its proprietary and versatile DIS® single-cell platform enables the rapid discovery of novel antibody therapeutics with predictive biomarkers through our internal development programs and strategic collaborations. Our passionate team across three continents embraces a fast-paced and engaging work environment to bring transformative medicines to patients.

HiFiBiO® and DIS® are trademarks of HiFiBiO and its affiliates.