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In Brief This Week: Kinnate Biopharma, Inceptor Bio, Innovent Biologics, Omega Therapeutics

NEW YORK – Kinnate Biopharma said this week that its pan-RAF inhibitor KIN-2787 cleared the predicted efficacious dose of 300 mg twice a day in its ongoing Phase I dose escalation trial. The firm will continue enrolling patients in the trial at the next-highest dosage, 400 mg twice a day, to determine the maximum tolerated dose. Kinnate said initial site activation of the trial was lower than expected due to COVID-19, which means there are few efficacy-evaluable patients. However, Kinnate expects to share additional dose escalation and initial efficacy data in the first half of 2023. The firm also announced its total cash and cash equivalents and investments were approximately $262 million, which is expected to fund operations through mid-2024. 

Inceptor Bio and Avectas said this week that they have partnered to develop and manufacture cell therapies for solid cancers. For its part of the collaboration, Dublin-based Avectas will bring its Solupore technology, which it designed as an alternative to electroporation, an element involved in engineering T cells. The non-viral Solupore technology, according to Avectas, is meant to result in a healthier T-cell product. Morrisville, North Carolina-based Inceptor Bio, meanwhile, will bring its CAR T-cell manufacturing process to the partnership, as well as its pipeline of CAR cell therapies, including CAR macrophages, CAR T cells, and CAR NK cells. 

Innovent Biologics said this week that China's National Medical Products Administration approved its new drug application for Retevmo (selpercatinib) 40 mg and 80 mg capsules for adults with locally advanced or metastatic non-small cell lung cancer with RET gene fusion, for children 12 and older with advanced or metastatic medullary thyroid cancer with a RET mutation, and for adults and children 12 and older with advanced or metastatic thyroid cancer with a RET gene fusion. 

Omega Therapeutics said this week that it has chosen OTX-2101 to advance into investigational new drug-enabling studies for non-small cell lung cancer. OTX-2101 is designed to control the expression of the c-Myc oncogene. In preclinical studies, OTX-2101 down-regulated MYC in NSCLC cell lines. 

Caris Life Sciences said this week that the University of Tennessee Medical Center's Cancer Institute has joined its Precision Oncology Alliance, a network of cancer centers that collaborate to advance precision oncology and biomarker-driven research. POA members work together to establish and optimize standards of care for molecular testing. They also gain access to Caris' extensive database and artificial intelligence platform, as well as a growing portfolio of biomarker directed trials. 

Grail and digital health firm Carrum Health said this week that they have partnered to provide Grail's multi-cancer early detection assay, Galleri, to Carrum's self-insured employer customers. The move allows these employers to make the test available to their eligible employees as part of Carrum's larger comprehensive cancer care services. Individuals who receive a signal detected from the test can work with a Carrum Health center of excellence for further diagnostic evaluation and guideline-concordant treatment planning. 

Menarini Silicon Biosystems said this week that the American Medical Association has issued Current Procedural Terminology Proprietary Laboratory Analyses codes for two of its CellSearch advanced liquid biopsy tests — CellSearch Circulating Multiple Myeloma Cell (CMMC) assay – 0337U, and CellSearch HER2 Circulating Tumor Cell (CTC-HER2) assay – 0338U. 

According to Menarini, the US Centers for Medicare and Medicaid Services made a preliminary proposal to price the cell isolation-based assays under the "gap fill" model, which bases pricing on cost data provided by the testing laboratory/manufacturer instead of previously established payment rates. The company did not list the preliminary prices but said final pricing for the two codes is expected to go into effect in January 2024. 

Cleveland Diagnostics said this week that its Medicare Administrative Contractor CGS Administrators has issued a final Local Coverage Decision for the firm's IsoPSA assay, establishing reimbursement for the test for millions of Medicare-enrolled individuals. The firm also said the American Medical Association has awarded a Proprietary Laboratory Analysis code (CPT-PLA) for the prostate cancer assay, which will be effective Jan. 1, 2023. 

Telix Pharmaceuticals this week announced that Health Canada has approved Illuccix (gallium (68Ga) gozetotide injection), an imaging agent used for staging and re-staging intermediate and high-risk prostate cancer and localizing tumor tissue in recurrent disease. The agent is used with PET imaging to identify prostate-specific membrane antigen lesions in men with suspected metastasis eligible for initial definitive therapy and for those with suspected recurrence with elevated prostate-specific antigen (PSA) levels in serum.

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.