AstraZeneca is once again tapping the Shanghai-based developer Amoy Diagnostics for new companion tests to be paired up with its cancer medicines in China, Japan and the EU.
AmoyDx has been working with the Big Pharma since early 2021 on developing a molecular companion diagnostic for precision therapies in ovarian cancer, with a test to assess homologous recombination deficiency, or interruptions in the body’s ability to repair damaged DNA. Prior to that, the companies secured an approval in China for a BRCA1/BRCA2 test to be used alongside AstraZeneca’s Lynparza (olaparib) for treating breast and ovarian cancers.
Now, the two companies will collaborate on prostate cancer tests to identify gene mutations that impede homologous recombination repair, or HRR, the process that helps drive the body’s DNA damage response.
In addition, AmoyDx and AstraZeneca will co-develop a BRCA test for Lynparza in the EU. The financial terms of the deal were not disclosed.
HRR and BRCA mutations are considered prime targets for a PARP inhibitor therapy such as Lynparza. The drug has, however, also shown a benefit regardless of their HRR mutation status in patients with metastatic, castration-resistant prostate cancer. Lynparza, which AstraZeneca is co-developing with Merck & Co., recently demonstrated that it could extend progression-free survival in such patients when combined with Johnson & Johnson’s Zytiga and the steroid prednisone.
AmoyDx also has cancer companion diagnostic collaborations with Amgen and the Germany-based Merck KGaA, among others.
With Amgen, the company has been working on a test for the KRAS inhibitor Lumakras (sotorasib) in non-small cell lung cancer for sale in Japan, while Merck KGaA enlisted AmoyDx’s help with its MET inhibitor Tepmetko (tepotinib) aimed at lung cancer patients in the Chinese market.
AstraZeneca, meanwhile, teamed up with Thermo Fisher Scientific late last year with a global, multiyear agreement for companion diagnostics across its precision medicine pipelines.
According to the drugmaker, more than 90% of AstraZeneca’s clinical drug candidates employ a targeted approach, spanning cancer and cardiovascular disease plus kidney, metabolic and respiratory conditions.
The two also aim to introduce paired diagnostics early in clinical trials, so tests will be ready to launch alongside an FDA green light, in addition to broader efforts to increase awareness of biomarker screening and the adoption of genomic testing.