HiFiBiO Therapeutics Announces Clinical Trial Supply Agreement to Evaluate HFB200301 in Combination with Tislelizumab in Patients with DIS® Selected Advanced Solid Tumors

CAMBRIDGE, MA – August 15, 2022 – HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company, announced today a clinical trial supply agreement with Novartis to evaluate tislelizumab, an anti-PD-1 immune checkpoint inhibitor, in combination with HiFiBiO’s HFB200301, an investigational first-in-class monoclonal anti-TNFR2 agonist antibody for the potential treatment of advanced solid tumor indications preselected by HiFiBiO’s proprietary Drug Intelligence Science (DIS®) platform.

HFB200301 is currently being evaluated as a single agent in the first-in-human dose escalation and expansion clinical trial (NCT05238883), with the intention of following up with a combination of HFB200301 and tislelizumab.

“Immuno-oncology therapies have significantly improved the way we treat cancers. Unfortunately, they are not effective in every patient, and many individuals are still left with few options. Combination immunotherapy approaches have become a promising solution for harder to treat cancers,” said Luigi Manenti, M.D., Chief Medical Officer at HiFiBiO Therapeutics. “HFB200301 has the potential to reenergize the immune system to fight against cancers, both as a single agent and in combination. We are excited to explore whether HFB200301 in combination with tislelizumab can further improve patient outcomes in DIS® selected cancers.”

“HiFiBiO is proud to highlight the potential of our DIS® platform to rapidly advance novel therapeutics like HFB200301 from targets to patients. Additionally, this collaboration showcases our continuing commitment to Open Innovation for the benefit of cancer patients with high unmet needs,” 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 HFB200301 program, including global R&D and commercial rights. Novartis has agreed to supply tislelizumab for use in combination with HFB200301.


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 indications that may benefit the most from HFB200301 treatment. HFB200301 is an investigational agent. Safety and efficacy have not been established. There is no guarantee that HFB200301 will become approved and commercially available anywhere globally.

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. www.hifibio.com

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