Burning Rock Biotech Limited is thrilled to announce the official signing of a Master Service Agreement (MSA) with Boehringer Ingelheim, focusing on the field of oncology companion diagnostics. This partnership’s key goal is to offer Chinese patients safer, more efficient, and more precise diagnostic methods and treatment options, thereby advancing innovation and progress in cancer treatment.
The primary objective of this collaboration is to advance clinical trials related to Boehringer Ingelheim’s innovative MDM2-p53 antagonist, brigimadlin (BI 907828), and to develop companion diagnostic products for the Chinese market. Brigimadlin, a novel small-molecule drug created by Boehringer Ingelheim as an MDM2-p53 antagonist, recently received approval from the China National Medical Products Administration (NMPA) for its Phase II clinical trial, named Brightline-2. This trial is designed to address locally advanced or metastatic MDM2-amplified, TP53 wild-type solid tumors, providing new treatment possibilities for patients with such cancers, including Biliary Tract Carcinoma (BTC). This approach opens up a “pan-tumor” treatment strategy targeting the MDM2-p53 axis, and previous Phase I studies have shown promising clinical efficacy, particularly in BTC patients.
With the formal approval of the Brightline-2 clinical trial, brigimadlin’s safety and efficacy will undergo further scrutiny. Burning Rock is well-prepared to play a crucial role in this endeavor, utilizing its dual-center, internationally accredited laboratory, a global companion diagnostics registration pipeline, a comprehensive biomarker development solution for drug research, and its extensive experience in clinical projects and companion diagnostics development and submissions. This support aims to offer new hope to patients dealing with challenging and rare cancers in China.
This collaboration represents a significant milestone in the development of companion diagnostics for innovative anti-cancer drugs, focusing on setting high standards in terms of quality and standardization in this vital area of healthcare innovation.