Therapy Areas: Oncology
HiFiBiO Therapeutics Inks Clinical Trial Supply Agreement to Evaluate HFB200301 in Combination with Tislelizumab in Patients with DIS Selected Advanced Solid Tumors
15 August 2022 - - US-based clinical-stage biotherapeutics company HiFiBiO Therapeutics has inked a clinical trial supply agreement with Swiss-American multinational pharmaceutical company Novartis (NYSE: NVS) 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 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.

Under the terms of the agreement, HiFiBiO Therapeutics will maintain control of the HFB200301 program, including global R and 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 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.

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 DIS single-cell platform enables the rapid discovery of novel antibody therapeutics with predictive biomarkers through our internal development programs and strategic collaborations.