NEW YORK – Burning Rock Biotech and Impact Therapeutics on Tuesday announced a global partnership to develop companion diagnostics to identify best responders to Impact's anti-DNA damage repair therapies, beginning with its PARP inhibitor senaparib.
Specifically, the Guangzhou, China-based next-generation sequencing firm Burning Rock will work with Impact — also based in China — to develop a companion diagnostic to select prostate cancer patients eligible for senaparib.
Through its CLIA- and CAP-certified labs in China and Irvine, California, Burning Rock will support global registrational trials, in which patients will be evaluated for biomarkers associated with treatment response. The company will also spearhead CDx regulatory submissions across multiple global regions.
The firm recently received clearance from the US Food and Drug Administration to begin a Phase II clinical trial evaluating senaparib as maintenance therapy for metastatic castration-resistant prostate cancer patients with homologous recombination repair gene alterations whose disease has not progressed following chemo. The clinical trial will take place in the US and China, among other regions.
In addition to the prostate cancer trial, Impact is evaluating senaparib as a treatment for certain patients with ovarian cancer, lung cancer, and other solid tumors. The firm is conducting a global Phase III trial evaluating senaparib monotherapy as first-line maintenance treatment for ovarian cancer patients; a Phase II clinical trial evaluating the agent as third-line therapy for ovarian cancer patients harboring BRCA1/2 mutations; and a Phase I/II clinical trial evaluating senaparib combined with chemotherapy for patients with advanced solid tumors or small-cell lung cancer.
Though Burning Rock and Impact will initially focus on the senaparib program, they will also explore and discover new biomarkers for other targeted agents in Impact's pipeline.
"Burning Rock's expertise and experience in the field of genetic sequencing will help drive the global development of senaparib and further accelerate Impact Therapeutics' pipeline development in the field of synthetic lethality," Jun Bao, Impact's president and CEO, said in a statement. "By establishing a long-term strategic partnership with Burning Rock, I am confident that there will be a strong synergy which would benefit patients all over the world."