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To provide testing services from CLIA labs in China and U.S. for IMPACT’s ATR inhibitor IMP9064 for Phase I/II clinical study.
November 4, 2021
By: Kristin Brooks
Managing Editor, Contract Pharma
Burning Rock Biotech Ltd. entered a collaboration with IMPACT Therapeutics to provide testing services for IMPACT’s development of its ATR inhibitor IMP9064, which received IND clearance from the U.S. FDA for the Phase I/II clinical study. The collaboration will be supported by Burning Rock’s Clinical Laboratory Improvement Amendments (CLIA) certified and College of American Pathologists (CAP) accredited labs in Guangzhou, China and California, U.S. IMP9064 is an ATR inhibitor discovered and developed by IMPACT Therapeutics, with worldwide intellectual property rights. In preclinical studies, IMP9064 was found to be a highly potent ATR inhibitor and is selective against other kinases. Additionally, IMP9064 has demonstrated high activities in several ATM-deficient cell lines and more active than reference compound in xenograft in vivo models, which could potentially lead to a wider therapeutic window, better tolerability in long-term administration as a single agent, and providing more flexibility in combination therapy. Senaparib, a PARP inhibitor developed by IMPACT Therapeutics, has been explored in several clinical studies worldwide. IMP9064 in combination with Senaparib will be evaluated in this clinical study to explore the combination therapy of an ATR inhibitor and a PARP inhibitor, which is highly anticipated in the DNA Damage Response (DDR) research field. Burning Rock’s two laboratories, which are located in Guangzhou, China and California, have both obtained the certificate issued by the CAP and the CLIA certificate issued by the Centers for Medicare and Medicaid Services (CMS). The certified laboratories have also supported the global strategic partnership with IMPACT Therapeutics in companion diagnostics (CDx) development for a pipeline of drugs in the field of synthetic lethality, including the CDx development of Senaparib.
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