HiFiBiO Therapeutics Announces Clinical Trial Supply Agreement to Evaluate HFB200603 in Combination with Tislelizumab in Patients with DIS® Selected Advanced Solid Tumors

CAMBRIDGE, MA – November 18, 2022 – HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company, announced today a second clinical trial supply agreement with Novartis to evaluate HiFiBiO’s HFB200603, a novel anti-BLTA monoclonal antibody in combination with tislelizumab, Novartis anti-PD-1 immune checkpoint inhibitor, for the treatment of advanced solid tumor indications preselected by HiFiBiO’s proprietary Drug Intelligence Science (DIS®) platform.

“The continuation of our collaboration with Novartis bring us a step closer to realize our vision to provide potentially curative immunotherapies for each and every patient using our Drug Intelligence Science (DIS®) platform approach for novel drug discovery and development“ said Liang Schweizer, Ph.D., Founder, Chairperson and CEO at HiFiBiO Therapeutics.

Under the terms of the agreement, HiFiBiO Therapeutics will maintain control of the HFB200603 program, including global R&D and commercial rights. Novartis has agreed to supply tislelizumab for use in combination with HFB200603.   


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 to enhance IFN-γ production and demonstrates favorable developability, pharmacokinetic and safety profiles.

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages. In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

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.