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In Brief This Week: Verismo Therapeutics, Fore Biotherapeutics, Merck, Caris Life Sciences

NEW YORK – The US Food and Drug Administration this week granted orphan drug designation to Verismo Therapeutics' autologous cell therapy, SynKIR-110, as a treatment for mesothelioma. University of Pennsylvania spinout Verismo developed the cell therapy using its KIR-CAR platform, which involves a modified natural killer-like receptor to improve treatment persistence and efficacy and get around some of the limitations that have been seen with CAR T-cell therapy for solid tumors. The firm expects to begin Phase I clinical trials of SynKIR-110 for patients with mesothelin-expressing ovarian cancer, cholangiocarcinoma, and mesothelioma during the first quarter of 2023. 

Fore Biotherapeutics said this week that the US Food and Drug Administration granted fast track designation to its BRAF inhibitor FORE8394 for treatment of patients with cancers bearing BRAF fusions V600 mutations. FORE8394 inhibits mutated forms of BRAF while sparing wild-type RAF. The company plans to begin a global Phase II trial in the fourth quarter of this year. 

Merck said this week that Japan's Ministry of Health, Labor, and Welfare approved Keytruda (pembrolizumab) for several indications. For patients with HR-negative, HER2-negative breast cancer at high risk of recurrence, Keytruda is approved to be given as neoadjuvant therapy and continued as adjuvant monotherapy after surgery. For renal cell carcinoma patients at increased risk of recurrence following nephrectomy, Keytruda is approved for adjuvant therapy. For patients with advanced or recurrent cervical cancer with no prior chemotherapy who are not amenable to curative treatment, Keytruda is approved in combination with chemotherapy. Also, for patients with stage IIB or IIC melanoma after complete resection, Keytruda is approved as adjuvant monotherapy. 

Caris Life Sciences has added two new institutions  St. Luke's University Health Network and Indiana University’s Melvin and Bren Simon Comprehensive Cancer Center  to its Precision Oncology Alliance, a global network of cancer centers that pledged to collaborate in advancing precision oncology and biomarker-driven researchThe Alliance currently includes 72 cancer centers and academic institutions, which enjoy early access to the firm’s database and artificial intelligence platform, enabling evidence-based standards for cancer profiling and molecular testing in oncology. Members also gain access to Caris’ CODEai database, which contains cancer treatment information and clinical outcomes data for over 275,000 patients. 

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.