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In Brief This Week: Northwell Health, Tempus, CARsgen, Baptist Cancer Center, HTG Molecular Diagnostics

NEW YORK – Northwell Health and Hamburg, Germany-based Indivumed said this week that they have successfully consented 1,000 patients in their ongoing cancer research biobanking collaboration. These patients have donated their biospecimens to be made available to researchers worldwide and are being used by Indivumed to define novel targets and subsequent therapies through use of its multiomics database.

Long Island-based Northwell said that its cancer institute diagnoses and cares for more than 19,000 new cancer patients annually. During a consented patient's normal treatment, the Northwell Health Biospecimen Repository research team applies the Indivumed standard operating procedure for collecting excess cancer tissue from various organ sites, including lung, breast, colorectal, and uterine. They then send the frozen tissue to Indivumed's US headquarters in Frederick, Maryland. These deidentified patient samples are then made available to scientists to further study at the Feinstein Institutes for Medical Research, Northwell Health's science arm, and others across the globe in an effort to advance cancer research, develop anti-tumor drugs, and enhance personalized medicine approaches.

Samples have been collected since 2017 at the start of a three-year agreement, and the partners initiated a new five-year partnership in 2020 to expand the cancer biobanking activities.

Tempus said this week that it will incorporate data from the Memorial Sloan Kettering Cancer Center OncoKB database and National Comprehensive Cancer Network's Clinical Practice Guidelines in Oncology into its clinical reports. Tempus reports will reflect therapy choices based on molecular profile and corresponding NCCN Guidelines recommendations and information from OncoKB, making it easier for physicians to optimize treatment plans for their patients, the company said.

The OncoKB database features detailed information regarding specific alterations in 682 cancer genes, curated from various sources, including US Food and Drug Administration drug labels, medical professional group guidelines, medical and scientific literature, and clinical trial eligibility criteria. The NCCN Guidelines are a comprehensive, continuously updated set of guidelines detailing the sequential management decisions and interventions that currently apply to 97 percent of cancers affecting patients in the US.

CARsgen said this week that the European Medicines Agency has granted priority medicines (PRIME) designation to the autologous CAR T-cell therapy CT041 for gastric/gastroesophageal junction cancer patients. The cell therapy, which has demonstrated encouraging safety and early efficacy in China- and US-based clinical trials, is designed to target CLDN18.2 and is the first CAR T-cell therapy to receive PRIME designation for a solid tumor indication.

Baptist Cancer Center this week announced a new initiative aimed at reducing lung cancer deaths in the mid-South by 25 percent by 2030. The multifaceted initiative, dubbed Mid-South Miracle, aims to increase biomarker testing and expand access to clinical trials, among other improvements related to treatment, prevention, and early detection. The program aims to ensure biomarker-directed treatment for each patient, the center said. Among financial supporters of the Mid-South Miracle are the Baptist Memorial Health Care Foundation, the National Institutes of Health, and the Patient-Centered Outcomes Research Institute.

HTG Molecular Diagnostics said this week that Icahn School of Medicine at Mount Sinai has joined its Transcriptome Panel Early Adopter Program. Under a research collaboration, for which HTG will provide in-kind laboratory services, Icahn Mount Sinai will use HTG's transcriptome panel and EdgeSeq technology in three clinical bladder cancer studies.

Molecular Templates said this week that its investigational drug MT-6402 was granted fast track designation by the US Food and Drug Administration for the treatment of patients with advanced non-small cell lung cancer expressing PD-L1. MT-6402 is currently being evaluated in a Phase I dose escalation and dose expansion trial in advanced solid tumors that express PD-L1, including NSCLC and head and neck cancer. The company plans to expand the study once a dose is selected to evaluate MT-6402 as a monotherapy in tumor-specific and basket cohorts.

Datar Cancer Genetics announced this week that its TriNetra blood test has received breakthrough device designation from the US Food and Drug Administration. The test detects circulating tumor cells to diagnose early-stage breast cancer and is indicated for asymptomatic women older than 40 with a physician’s prescription. The assay is CE marked and already available in Europe.

The US Food and Drug Administration this week granted orphan drug designation to Gracell Biotechnologies' CAR T-cell therapy GC012F for multiple myeloma. The cell therapy, which simultaneously targets BCMA and CD19 on the surface of multiple myeloma cells, is designed using Gracell's FasTCAR next-day manufacturing technology. GC012F is currently being evaluated in Phase I trials across China.

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.