Abbisko Therapeutics Co. Ltd. has received FDA clearance of its IND application for ABSK-012, a highly selective small-molecule inhibitor of fibroblast growth factor receptor 4 (FGFR4), for advanced solid tumors.
Briacell Therapeutics Corp. has received IND clearance from the FDA to begin clinical studies with Bria-OTS, the first generation of the company’s personalized off-the-shelf cellular immunotherapy for breast cancer.
Angiex Inc. has received FDA clearance of its IND application for AGX-101, a novel TM4SF1-directed antibody-drug conjugate (ADC) being developed for the treatment of solid cancers.
The FDA has awarded U.S. orphan drug designation and rare pediatric disease designation to Huidagene Therapeutics Co. Ltd.’s HG-204 (AAV-hfCas13Y-gMECP2), an RNA editing therapy based on CRISPR/Cas13Y, for the treatment of methyl-CpG binding protein 2 (MeCP2) duplication syndrome (MDS).
Virpax Pharmaceuticals Inc. expects to submit an IND application for Envelta (MET-LENK) around the middle of next year following review of comments made by the FDA on the company’s pre-IND submission. If successful, first-in-human trials would also be expected to begin around the middle of the year.
Chimeric Therapeutics Ltd. has received FDA clearance of its IND application for CHM-2101, a first-in-class CDH17 chimeric antigen receptor (CAR) T cell therapy for gastrointestinal (GI) cancers.
The FDA has accepted Mustang Bio Inc.’s IND application of MB-109 for the treatment of recurrent glioblastoma (GBM) and high-grade astrocytoma. MB-109 is a treatment regimen combining MB-101 (City of Hope-developed IL13Rα2‐targeted CAR T-cell therapy) and MB-108 (Nationwide Children’s Hospital-developed HSV-1 oncolytic virus).
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