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In Brief This Week: Datar Cancer Genetics, Daiichi Sankyo, ProPhase Labs, Innovent Biologics

NEW YORK – Datar Cancer Genetics said this week it secured US Food and Drug Administration breakthrough device designation for the firm's liquid biopsy to help diagnose inaccessible brain tumors. The India-based firm's blood-based TriNetra-Glio test uses proprietary circulating tumor cell enrichment and detection technology to aid identification of malignant brain tumors when they cannot be accessed for a brain biopsy or a biopsy is unsuccessful. The firm said it has also received CE marking for the test, which is sold in Europe under the name Trublood-CNS. 

Daiichi Sankyo this week said that the European Medicines Agency validated its Type II Variation application for the use of Enhertu (trastuzumab deruxtecan) as a treatment for patients with unresectable or metastatic non-small cell lung cancer whose tumors harbor activating HER2 mutations and who have previously received a systemic therapy. The validation confirms that the application is complete and begins review by the EMA's Committee for Medicinal Products for Human Use. The application is supported by the DESTINY-Lung02 Phase II trial and the DESTINY-Lung01 Phase II trial

ProPhase Labs said this week it closed its $4.6 million acquisition of the exclusive rights to Stella Diagnostics' BE-Smart Esophageal Pre-Cancer screening test and related intellectual property assets. The firm expects to commercialize the test within 18 months. ProPhase said last month it had reached a purchase agreement with Stella, and updated purchase figures in this week's announcement indicate Stella received $3.6 million in cash and $1 million in ProPhase common stock and will receive another $2 million in ProPhase common stock upon hitting a revenue-based commercial milestone within five years. Stella also will receive a 5 percent royalty based on the adjusted gross margin from commercialization of the intellectual property. 

Innovent Biologics said this week that China's National Medical Products Administration (NMPA) granted breakthrough therapy designation for its KRAS inhibitor IBI351 for the treatment of advanced non-small cell lung cancer patients with a KRAS G12C mutation who have received at least one prior line of systemic therapy. The NMPA designation was based on data from a Phase I trial in China that showed a response rate of 50.9 percent and disease control rate of 92.7 percent among 55 evaluable patients. Of 21 patients treated with the recommended Phase II dose, 61.9 percent responded to treatment with IBI351 and the disease control rate was 100 percent. 

Caris Life Sciences and Xencor said this week that they have expanded their collaboration to research, develop and commercialize antibodies directed against novel targets for the treatment of patients with cancer. 

The new agreement builds on an initial partnership announced last August, expanding the number of targets and cancer types that Caris will interrogate with its multiomics discovery engine, Caris Discovery. Under the new terms, Xencor will receive exclusive worldwide rights to research, develop, and commercialize products directed to up to three targets. Caris will receive an upfront payment and will be eligible to receive up to $187 million in development and commercial milestone payments, royalties on net sales of commercialized products resulting from the collaboration, and future rights for molecular profiling and companion diagnostics. 

Burning Rock said this week that its OverC multi-cancer detection blood test has been granted breakthrough device designation by the US Food and Drug Administration, a classification that offers an eased assessment and review process for novel medical products. 

The OverC assay is intended for early detection of esophageal, liver, lung, ovarian, and pancreatic cancers in adults of either sex, aged 50-75 years old with average risk for cancer. In a case control study, the test demonstrated 69 percent sensitivity and nearly 99 percent specificity, and Burning Rock is now in the process of conducting prospective interventional validation studies in an asymptomatic population. 

DermTech announced this week that four commercial payors — Blue Cross Blue Shield of North Carolina, South Carolina, Louisiana, and Kansas City — will cover the firm’s DermTech Melanoma Test. The policies were announced pursuant to an independent technology assessment by a laboratory benefits manager and are similar to the policy created by the Centers for Medicare and Medicaid Services for the test, DermTech said in a statement. The firm also entered into an agreement with a Blues plan in Michigan. The test is now covered for about 104 million people in the US, it added. 

Nouscom said this week that it has partnered with Merck to evaluate its investigational cancer vaccine NOUS-209 plus Merck's checkpoint inhibitor Keytruda (pembrolizumab) for metastatic colorectal cancer or gastric cancer patients whose tumors are DNA mismatch repair deficient or have high microsatellite instability. NOUS-209 targets 209 neoantigens found in DNA mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal, gastric, and gastroesophageal junction tumors. Nouscom began treating patients within its Phase II randomized trial in November. 

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.