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BroadenBio's BB3008 approved by CDE & FDA to enter clinic for advanced solid tumors
Time of issue：
2023-09-30
Author:
BroadenBio
Origin:
BroadenBio
BB3008, a selective small molecule HPK1 inhibitor independently developed by BroadenBio Co., Ltd. (BroadenBio), has received approvals from CDE and FDA in September 2023, for the Investigational New Drug (IND) Application of conducting clinical trials on advanced solid tumors.
Hematopoietic progenitor kinase 1 (HPK1), also known as MAP4K1, is a serine/threonine kinase mainly expressed in immune cells (T cells, B cells, dendritic cells, macrophages, and etc.). HPK1 is a key negative feedback regulator of the T cell receptor (TCR) signaling pathway. As an important intracellular immune checkpoint, HPK1 inhibits the proliferation and functions of T cells and B cells, and also inhibits the antigen presentation by dendritic cells (DCs). Clinical studies have observed upregulation of HPK1 levels in various tumor tissues such as leukemia, bladder cancer, breast cancer, and colon cancer. HPK1 inhibition can restore the immunology functions in tumor microenvironment and enhance T cell-mediated anti-tumor immune effects. Therefore, HPK1 is a potential target for immuno-oncology therapy.
BB3008 is a highly selective small molecule inhibitor of HPK1 with novel molecular structure developed independently by BroadenBio. BB3008 significantly activates T cell activity in vitro, shows pronounced tumor growth inhibition both as monotherapy and in combination with PD-1 inhibitors, and has excellent pharmacokinetics properties and controllable safety. The preclinical study of BB3008 was been published as "Late-Breaking Research" at the 2023 Annual Meeting of the American Association for Cancer Research (AACR). BB3008, as monotherapy or in combination, will be used to overcome the immune suppressive tumor microenvironment and treat malignant solid tumors in clinical trials.
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