Burning Rock Collaborates with IMPACT Therapeutics to Provide Testing Services in Developing IMP9064 in both US and China

Rhea-AI Summary

Burning Rock Biotech Limited (NASDAQ: BNR) announced a collaboration with IMPACT Therapeutics to provide testing services for the ATR inhibitor IMP9064, which has received IND clearance from the FDA for a Phase I/II clinical study in the U.S. The collaboration leverages Burning Rock's CLIA-certified labs in Guangzhou, China and California. IMP9064 shows high potency against ATR, suggesting a promising therapeutic window, especially in combination with Senaparib. This partnership supports Burning Rock's expansion in precision oncology and strengthens its capabilities in companion diagnostics.

Positive

• Collaboration with IMPACT Therapeutics enhances research capabilities.
• IND clearance by FDA for IMP9064 signifies regulatory approval for clinical studies.
• Burning Rock's CLIA-certified labs expand its operational footprint in the U.S.

Negative

• None.

GUANGZHOU, China, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced a collaboration with IMPACT Therapeutics where Burning Rock provides testing services in connection with IMPACT Therapeutics’ development of its ATR inhibitor IMP9064, which has received the Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the Phase I/II clinical study, and will begin soon in the U.S. 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.

The two laboratories of Burning Rock, which are located in Guangzhou, China and California, U.S., 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. Please refer to the Company’s press release dated August 3, 2021 for further details on the global strategic partnership.

About IMPACT Therapeutics
IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. IMPACT Therapeutics has assembled one of the most comprehensive DNA damage response (DDR) global pipeline of novel drug candidates generated by in-house discovery efforts and is expanding to other novel synthetic lethality targets to broaden its pipeline. IMPACT pipeline products include PARP inhibitor (Senaparib/ IMP4297), Wee1 inhibitor (IMP7068), and other novel DDR pathway inhibitors. The lead clinical program, PARP inhibitor (Senaparib/ IMP4297), is in Phase II/III studies for ovarian cancer, prostate cancer, small cell lung cancer and other indications worldwide, including China. Senaparib’s preliminary clinical data demonstrated superior tolerability and wider therapeutic window compared with other PARPi. Phase I study of Wee1 inhibitor (IMP7068) is conducted globally. ATR Inhibitor IMP9064 has received IND Clearance by FDA to start clinical studies in the U.S. and Hedgehog pathway inhibitor (IMP5471) has received IND approval from NMPA to initiate clinical studies in China.

For more information, please visit www.impacttherapeutics.com

About Burning Rock
Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, with the leading market share in China and over 273,000 tissue and liquid-based tests completed cumulatively, and ii) cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.

For more information about Burning Rock, please visit: ir.brbiotech.com.

Safe Harbor Statement
This press release contains forward-looking statements. These statements constitute “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “target,” “confident” and similar statements. Burning Rock may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about Burning Rock’s beliefs and expectations, are forward-looking statements. Such statements are based upon management’s current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond Burning Rock’s control. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. All information provided in this press release is as of the date of this press release, and Burning Rock does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.

Contact: IR@brbiotech.com

FAQ

What is the significance of Burning Rock's collaboration with IMPACT Therapeutics regarding IMP9064?

The collaboration allows Burning Rock to provide essential testing services for IMP9064, an ATR inhibitor, which has received FDA clearance for clinical trials, enhancing its role in precision oncology.

When will the clinical study for IMP9064 begin in the U.S.?

The clinical study for IMP9064 is expected to commence soon following the FDA's IND clearance.

What are the potential benefits of the ATR inhibitor IMP9064?

IMP9064 has shown high potency as an ATR inhibitor and may offer a wider therapeutic window and better tolerability, especially in combination with Senaparib.

How does Burning Rock's certification impact its operations?

Burning Rock's CLIA certification signifies adherence to quality standards, enhancing its credibility and operational capacity for clinical testing.