On October 9, 2023 HiFiBiO Therapeutics, a clinical stage global biotech company focusing on improving patient lives with single cell precision, reported that the Chinese National Medical Products Administration (NMPA) has approved the company’s Investigational New Drug (IND) application for HFB200301, a pioneering, first-in-class anti-TNFR2 agonistic monoclonal antibody (Press release, HiFiBiO Therapeutics, OCT 10, 2023, View Source [SID1234635720]).
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HFB200301 is currently undergoing Phase I clinical trial (NCT05238883) evaluation in the treatment of advanced solid tumors in the United States and Europe, both as a monotherapy and in combination with tislelizumab, an anti-PD-1 immune checkpoint inhibitor. This trial is guided by HiFiBiO’s proprietary Drug Intelligence Science (DIS) platform, which utilizes patient data to optimize dosages, dosing regimens, indication selection, and biomarker strategies.
Liang Schweizer, PhD, Founder, Chairperson, and CEO of HiFiBiO Therapeutics, commented on this significant development, saying, "The approval of our HFB200301 IND by the NMPA represents yet another pivotal milestone for the program, confirming our strong commitment to developing safe and effective treatments for cancer patients globally."
"Incorporating Chinese patients into our study will provide invaluable insights into the therapeutic potential of HFB200301 across a diverse patient population, ultimately guiding our efforts to develop novel immuno-oncology treatments to patients with significant unmet medical needs," emphasized Robert Andtbacka, MD, CM, CMO of HiFiBiO Therapeutics.
Under the terms of the previously announced clinical supply agreement, Novartis will supply tislelizumab for use in combination with HFB200301, and HiFiBiO Therapeutics will maintain control of the HFB200301 program, including global R&D and commercial rights.
HFB200301
HFB200301 is a first-in-class anti-TNFR2 agonistic monoclonal antibody that binds potently and selectively to TNFR2, and induces the activation of CD4 T cells, CD8 T cells, and NK cells. HFB200301 demonstrates potent antitumor activity as a monotherapy and in combination with anti-PD-1 in animal tumor models. HiFiBiO is implementing a biomarker strategy, leveraging its DIS platform, to identify indications that may benefit the most from HFB200301 as a monotherapy or as a combination therapy.
Tislelizumab
Tislelizumab, an investigational humanized IgG4 anti-PD-1 monoclonal antibody, is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages. Pre-clinical studies have shown that binding to Fcγ receptors on macrophages can compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.