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In Brief This Week: Oryzon Genomics, Byondis, Caris Life Sciences, Natera

NEW YORK –  Biopharmaceutical firm Oryzon Genomics said this week that it has inked a cooperative research and development agreement with the US National Cancer Institute to expand its LSD1 inhibitor iadademstat to additional solid and hematological cancer indications. The company is already studying the drug in various settings, for example as a single agent for acute myeloid leukemia and in combination with Astellas' Xospata (gilteritinib) in FLT3-mutant relapsed or refractory AML. The new CRADA "dramatically expands our ability to conduct clinical trials in a wide number of indications and in combination with other novel or established therapies such as immuno-oncology and molecularly targeted agents," Oryzon Chief Medical Officer Douglas Faller said in a statement. 

Byondis said this week that the US Food and Drug Administration accepted its submission of a biologics license application for trastuzumab duocarmazine (SYD985), an anti-HER2 antibody-drug conjugate, for unresectable locally advanced or metastatic breast cancer. The FDA is expected to make a decision on the application by May 12, 2023. The drug was granted fast track designation by the FDA in 2018. 

Caris Life Sciences said this week that the Northside Hospital Cancer Institute has joined its Precision Oncology Alliance, a growing network of cancer centers that collaborate to advance precision oncology and biomarker-driven research. NHCI has been offering cancer care services in Georgia since 1978. It has one of the largest community-based oncology research networks in the nation and is one of a small number of community cancer care programs offering Phase I-IV clinical trials. Northside also leads Georgia's National Cancer Institute Oncology Research Program and is one of 15 US biorepositories for the National Institute of Health's Cancer Moonshot Biobank Program. 

Caris' POA currently includes 69 cancer centers and academic institutions, which receive early access to the firm's database and artificial intelligence platform. 

Natera said this week that its Signatera assay has met the coverage requirements for patients with muscle invasive bladder cancer under the Centers for Medicare and Medicaid Services’ MolDx program, effective April 19, 2022. The test is covered under the program’s local coverage determination for minimal residual disease testing for cancer, which went into effect in December 2021. Signatera is also covered by Medicare for colorectal cancer and pan-cancer immunotherapy monitoring. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.