On November 21, 2023 BroadenBio reported that the company successfully completed the administration of the first patient in Phase I clinical trials of the independently developed, small molecule HPK1 inhibitor BB3008 at the Cancer Hospital Chinese Academy of Medical Sciences (Press release, BroadenBio, NOV 21, 2023, View Source [SID1234640207]). This clinical trial is led by Professor Jing Huang from the Cancer Hospital Chinese Academy of Medical Sciences, which aims to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of oral BB3008 tablets in patients with advanced solid tumors. Currently, no drug with the same target has been approved for marketing in the world, and all candidates are in the early clinical research stage.
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BB3008 is a highly potent and selective small molecule inhibitor of HPK1 that has been approved by China NMPA and the US FDA. It is currently undergoing phase I clinical trials in China for patients with advanced solid tumors regardless of cancer type. HPK1 is an intracellular immune checkpoint mainly expressed in immune cells (T cells, B cells, dendritic cells, macrophages, and etc.). It is a key negative feedback regulator of the T cell receptor (TCR) signaling pathway and inhibits the immune function of T cells. As a highly selective HPK1 inhibitor, BB3008 activates the anti-tumor function of T cells by blocking the HPK1-mediated negative feedback mechanism of TCR signaling, and breaks through the limitation of insufficient response rates of current immune checkpoint inhibitors. In preclinical studies, BB3008 showed significant tumor-growth inhibition efficacy in various syngeneic mouse tumor models, and synergic anti-tumor effect in combination with PD-1 antibody. BB3008 has good safety profiles, and no immune-related adverse effect has been observed in preclinical animal experiments.
"The successful administration of BB3308 for the first patient means that BB3008, as a clinical drug candidate, has entered the global competition for clinical development on the innovative target HPK1. I would like to express my sincere thanks to the team of Professor Jing Huang from the Cancer Hospital Chinese Academy of Medical Sciences for their strong support, and I am also grateful to the company’s team for their devotion," said Xingmin Zhang, M.D., Ph.D., founder and Chief Executive Officer of BroadenBio. "We look forward to efficiently promoting the clinical research of BB3008 continuously with everyone’s joint efforts and benefiting cancer patients as soon as possible."