Benzinga | Apr 29, 2021 07:36AM EDT

Burning Rock Biotech And Abbisko Therapeutics To Develop CDx Assay For ABSK091

Burning Rock Biotech Limited (NASDAQ:BNR, the &quot, Company&quot, or &quot, Burning Rock&quot, ))))) today announced a strategic partnership with Abbisko Therapeutics ("Abbisko") in companion diagnostics (CDx). The two companies will work together to develop a CDx assay for ABSK091 (formerly known as AZD4547) to advance clinical research and development of the drug. The CDx assay is designed to detect FGFR genetic alterations in patients with urothelial carcinoma.



ABSK091 is an innovative small molecule FGFR inhibitor, of which Abbisko has the exclusive global rights for development, manufacture, and commercialization. In prior preclinical and multiple clinical studies, ABSK091 has demonstrated good safety and tolerability profiles, as well as preliminary efficacy in cancer patients harboring FGFR alterations.

"In the era of precision medicine, personalized cancer therapy relies on precise diagnosis. Leveraging the leading next generation sequencing (NGS) technology, well-proven lab quality control protocol and integrated service system for pharmaceutical companies, Burning Rock will support its partners in the development of innovative oncology drugs," said Xinru Mao, Head and Senior Director of Pharmaceutical Business Development, Burning Rock, "ABSK091 has shown the potential to treat patients with FGFR signaling pathway-dependent tumors in previous studies. Our collaboration with Abbisko is expected to maximize each other's strengths to further advance the standardization of FGFR detection for patients with urothelial carcinoma in China."

"As a potent and selective FGFR inhibitor, ABSK091 has the potential to treat a variety of tumors harboring FGFR alterations. Abbisko has obtained the investigational new drug (IND) approval of ABSK091 from National Medical Products Administration (NMPA) for the treatment of patients with urothelial carcinoma, and will initiate phase Ib/II multi-center clinical trials in China soon," said Jing Ji, Chief Medical Officer of Abbisko, "We look forward to working with Burning Rock to accelerate the clinical development and advance this innovative drug into market as early as possible to provide a novel treatment option for patients and doctors."