On October 19, 2020 Betta Pharmaceutical Co., Ltd. reported that the first subject of the Phase I clinical study of the new drug BPI-27336 was successfully enrolled (Press release, Betta Pharmaceuticals, OCT 19, 2020, View Source [SID1234574036]). On October 20, the patient’s first administration was completed. The study is called "Phase I clinical study of BPI-27336 tablets in patients with advanced solid tumors", and the main investigator is Professor Shen Lin from Beijing Cancer Hospital. The study includes two parts: dose escalation and enrollment expansion. The main goal is to evaluate the safety and tolerability of BPI-27336 as a selective ERK1/2 small molecule inhibitor for patients with advanced solid tumors, explore the maximum tolerated dose (MTD) and Dose-limiting toxicities (DLTs), as well as determining the recommended dose for later clinical studies, and evaluating the initial efficacy.
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Mechanism of action of BPI-27336
ERK1/2 is an important member of the mitogen-activated protein kinases (MAPK) family, located downstream of the RAS/RAF/MEK/ERK (RAS-MAPK) pathway. The RAS-MAPK signaling pathway is involved in a series of cell physiological activities such as cell growth, development, differentiation, and apoptosis, and is the hardest hit area that induces tumors. Domestic and foreign literature reports that MAPK is obviously related to the occurrence and development of lung cancer, breast cancer, ovarian cancer, esophageal cancer, colon cancer, stomach cancer, liver cancer and other tumors. As the "final manager" downstream of the RAS-MAPK pathway, targeted inhibition of ERK1/2 is expected to be used to treat cancer caused by abnormal activation of the RAS-MAPK pathway, and may also be resistant to RAF or MEK inhibitors due to the reactivation of ERK1/2 The medicine is effective for patients.
Up to now, there is no drug marketed for ERK target in the world. As a new type of potent and selective ERK1/2 small molecule oral inhibitor, BPI-27336 has shown excellent anti-tumor effects in a variety of preclinical disease models, especially KRAS mutant tumor models, and has good safety. Sex, tolerability and pharmacokinetic characteristics. BPI-27336 is expected to improve the drug resistance of the RAS-MAPK pathway and enhance the efficacy, and it is expected to bring a breakthrough in the drugless global problem of KRAS mutant tumors. We look forward to accelerating the progress of clinical research with the help of the cooperation center and experts, providing patients with new treatment plans and meeting urgent clinical needs.
According to the announcement of the work plan for the registration and classification of chemical drugs, BPI-27336 is an "innovative drug that has not been marketed at home or abroad", and its registration is classified as category 1 chemical drugs. In February 2020, Betta Pharmaceuticals received the "Clinical Trial Notice" issued by the National Medical Products Administration (NMPA). BPI-27336 tablets meet the requirements of relevant drug registration regulations and agreed to carry out clinical research on solid tumors in accordance with the submitted plan (Acceptance number CXHL1900397, CXHL1900398).