HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200301

HFB200301 is a First-In-Class TNFR2 Agonist Antibody for the treatment of DIS® Defined Solid Tumors

CAMBRIDGE, MA., HONG KONG, HANGZHOU, SHANGHAI, and PARIS – November 1, 2021 – HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for HFB200301. HFB200301 is a first-in-class monoclonal agonist antibody designed to promote an antitumor response by stimulating both innate and adaptive immune systems through TNFR2 in solid tumors identified through HiFiBiO’s Drug Intelligent Science (DIS®) platform.

“The FDA’s clearance of our IND for HFB200301 is an important milestone for HiFiBiO as it further demonstrates the power of our single cell-powered DIS® platform to identify and develop novel therapeutics. This milestone also signifies our transition to a clinical stage company,” said co-founder and CEO of HiFiBiO Therapeutics, Liang Schweizer, Ph.D. “The FDA’s clearance brings us one step closer toward achieving our mission of delivering novel therapeutics that improve treatment options for cancer patients”

“We were excited to discover that our TNFR2 clinical candidate not only stimulated effector CD4 and CD8 T cells, but also activated NK cells to drive anti-tumor activity” shared Francisco Adrián, Ph.D., CSO of HiFiBiO Therapeutics. “HFB200301 has shown strong in vivo efficacy alone and combined with anti-PD-1 at doses well tolerated in mice and NHPs.”

“The planned Phase 1 clinical study will consist of an initial dose escalation followed by expansion cohorts in selected solid tumors identified through HiFiBiO DIS® platform. The company is also exploring a potential combination with checkpoint inhibitor therapy”, said Luigi Manenti, M.D., CMO of HiFiBiO Therapeutics. “We remain committed to further developing novel immune therapies for patients with cancer and autoimmune diseases.”

HFB2003 (TNFR2)

HFB200301 is a first-in-class agonistic anti-TNFR2 antibody that binds potently and selectively to TNFR2 and induces the activation of CD4 T cells, CD8 T cells and NK cells. In vivo, HFB200301 demonstrates potent antitumor activity as a single agent and in combination with anti-PD-1. HiFiBiO is applying a biomarker strategy by leveraging its DIS® platform to select patients who may benefit the most from HFB200301 treatment.

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 disease. Our 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. www.hifibio.com.

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