Burning Rock and IMPACT Therapeutics Announce Global Strategic Partnership for the Development of Companion Diagnostics



GUANGZHOU, China, August 03, 2021 (GLOBE NEWSWIRE) – Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced a global strategic partnership with Therapeutic IMPACT in the development of companion diagnostics (CDx) for a drug pipeline in the area of ​​synthetic lethality. The two companies will jointly develop CDx for a targeted oncology drug, Senaparib (IMP4297), a PARP inhibitor, for the treatment of prostate cancer worldwide, including CDx submissions to both the Food and Drug Administration ( FDA) of the United States and the National Medical Products Administration. of China (NMPA). The global program will be supported by Burning Rock’s Clinical Laboratory Improvement Amendments (CLIA) certified laboratories and accredited by the College of American Pathologists (CAP) in Guangzhou, China and California, United States. In addition, the two companies will deepen their collaborations in the exploration and discovery of new biomarkers for a pipeline of targeted drugs.

Senaparib is a PARP inhibitor developed by IMPACT Therapeutics. A number of clinical trials of Senaparib have been conducted globally, including the ongoing Phase III clinical trial of Senaparib as monotherapy as 1st line maintenance treatment in ovarian cancer, the Phase II clinical trial of Senaparib as the 3rd line therapy in the treatment of patients with ovarian cancer carrying a BRCA mutation, and a phase I / II clinical trial of combined Senaparib and TMZ therapy in patients with advanced solid tumors and cancer of the small cell lung. Recently, IMPACT Therapeutics received US FDA approval to initiate a clinical study of IMP4297 in the treatment of metastatic castration-resistant prostate cancer (mCRPC). The aim of this study is to evaluate the efficacy and safety of Senaparib in the maintenance treatment of patients with mCRPC with alterations in the homologous recombination repair (HRR) gene who have not progressed after treatment. treatment with docetaxel. The multiregional clinical trial (MRCT) will begin soon in several regions, including the United States and China.

The two Burning Rock laboratories, located in Guangzhou, China and California, USA, have both obtained the certificate issued by the CAP and the CLIA certificate issued by the Centers for Medicare and Medicaid Services (CMS). Certified laboratories can support global clinical registration trials for biomarker detection as well as CDx submission. As the first CDx project filed in the NGS area with simultaneous trials in China and the United States, the partnership will accelerate Senaparib’s clinical research program to benefit patients worldwide.

Dr Jun Bao, President and CEO of IMPACT Therapeutics, said, “Burning Rock’s expertise and experience in gene sequencing will help drive Senaparib’s global development and further accelerate development. of IMPACT Therapeutics’ synthetic lethality pipeline. By establishing a long-term strategic partnership with Burning Rock, I am confident that there will be a strong synergy that will benefit patients around the world.

Yusheng Han, Founder and CEO of Burning Rock, said, “IMPACT Therapeutics has one of the most diverse drug pipelines in the field of synthetic lethality. Senaparib’s clinical and preclinical data have demonstrated its potential as a primary, first-line maintenance treatment for patients with mCRPC. Burning Rock and IMPACT Therapeutics have established a long-term strategic partnership for the development of a pipeline of targeted oncology drugs in the area of ​​synthetic lethality and will build on each other’s strengths to develop the corresponding CDx. Oncology drugs and CDx will be launched simultaneously to provide patients with safe and effective therapies. “

About IMPACT Therapeutics
IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted cancer therapies based on synthetic lethality. IMPACT Therapeutics has assembled one of the world’s most comprehensive DNA damage response (DDR) pipelines of novel drug candidates generated by internal discovery efforts and expands to other novel synthetic lethality targets to expand its pipeline. Products in the IMPACT pipeline include PARP inhibitor (senaparib / IMP4297), Wee1 inhibitor (IMP7068) and other novel inhibitors of the DDR pathway. The main clinical program, the PARP inhibitor (senaparib / IMP4297), is in a phase III study in China, and a global clinical trial-mCRPC study that has received FDA IND approval. Preliminary clinical data from Senaparib demonstrated superior safety and a wider therapeutic window compared to other iPAPs. The phase I study of the Wee1 inhibitor (IMP7068) is being conducted worldwide.

For more information, please visit www.impacttherapeutics.com

About Burning Rock
Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to protect life through science, is focused on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapeutic screening tests for patients with advanced cancer, with the main market share in China and more than 273,000 tissue and fluid-based tests performed. cumulatively, and ii) early detection of cancer, which has gone beyond proof-of-concept R&D into the clinical validation phase.

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

Safe Harbor Declaration
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 United States Private Securities Litigation Reform Act of 1995. These forward-looking statements may be identified by terminology such as “will”, “expects”, “anticipates”, “future”, “intends”, “plans”, “believes”, “believes”, “targets”, “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 individuals. third. Statements that are not historical facts, including statements about Burning Rock’s beliefs and expectations, are forward-looking statements. These statements are based on current management 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 such statements. All information provided in this press release is as of the date of this press release, and Burning Rock makes no commitment to update any forward-looking statement as a result of new information, future events or otherwise, unless applicable law requires it. .

Contact: [email protected]

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