The clinical trial application of BPB-101 bispecific antibody injection of Betta Pharma was accepted

Recently, Betta Pharmaceutical received the "Notice of Acceptance" issued by the National Medical Products Administration (acceptance number: CXSL2200622), and the clinical trial application of BPB-101 bispecific antibody injection declared by the company has been accepted by the National Medical Products Administration.

BPB-101 bispecific antibody injection is the first new first-in-class (FIC) macromolecule new drug independently developed by Betta Pharmaceutical, with completely independent intellectual property rights, with three-function bispecific IgG1 subtype humanized antibody. This product is intended for the treatment of a variety of advanced solid tumors, including but not limited to non-small cell lung cancer, ovarian cancer, breast cancer, esophageal cancer, melanoma, endometrial cancer, bladder cancer, cholangiocarcinoma, colorectal cancer, liver cancer and other cancer patients.

Preclinical studies have shown that BPB-101 can specifically target GARP-TGF-β complex, mature TGF-β and PD-L1, thereby relieving the dual immunosuppression of the TGF-β signaling axis and the PD-1/PD-L1 signaling axis in the tumor microenvironment, restoring and enhancing the killing effect of immune cells on tumor cells, thereby inhibiting tumor growth and survival.

Dr. Xu Wenxin, senior director of immunology at Betta Pharmaceutical, said that the tumor microenvironment is an important "shelter" for the growth, reproduction, metastasis and invasion of malignant tumor cells. In the tumor microenvironment, the PD-L1/PD-1 signaling axis and the TGF-β signaling axis are complementary, non-redundant immunosuppressive signaling pathways. Inhibiting the two signaling pathways at the same time can not only restore and enhance the killing of tumor cells by immune cells, increase the overall benefit of patients, but also exert a joint inhibitory effect on the bypass activation pathway that causes drug resistance. BPB-101 can specifically bind to the GARP-TGF-β or SLC complex, block the source of TGF-β, and at the same time, specifically neutralize the mature TGF-β in the tumor microenvironment, and completely remove the inhibition of the TGF-β axis. BPB-101 has an excellent PD-L1 single-domain antibody target, which specifically blocks the immunosuppressive effect of PD-1/PD-L1 and CD-80/PD-L1 formation. In addition, BPB-101 can also inhibit the negative regulatory function of Treg cells and enhance the anti-tumor efficacy of immune effector cells. These characteristics indicate that BPB-101 is a drug molecule different from the existing PD-(L)1/TGF-β(R) or GARP antibodies, and is a broad-spectrum anti-tumor drug with broad clinical application prospects for many solid tumors.

Dr. Wang Jiaping, Senior Vice President and Chief Scientist of Betta Pharmaceutical, said BPB-101 therapeutic bispecific antibody has passed sufficient preclinical studies and safety evaluation, and has demonstrated excellent in vivo and in vivo pharmacodynamic activity, good pharmacokinetics and safety characteristics. As the company's first brand-new FIC macromolecule drug with completely independent intellectual property rights, it is expected to bring better treatment options to more patients and further enhance the company's influence in the field of tumor treatment.