The FDA has cleared an IND application for a phase I/II study of KSQ-004EX, KSQ Therapeutics Inc.’s second engineered tumor-infiltrating lymphocyte (eTIL) program. KSQ-004EX consists of TIL in which the genes encoding SOCS1 and Regnase-1 are inactivated using CRISPR/Cas9 gene editing.

Ribometrix Inc. recently discussed the discovery and preclinical evaluation of a novel potent and selective eukaryotic translation initiation factor 4E (eiF4E) inhibitor, RBX-6610, being developed for the treatment of KRAS-mutant non-small-cell lung cancer (NSCLC).

Australia is the skin cancer capital of the world, but with a shortage of dermatologists, patients often wait too long to get skin checks that could end up costing them their lives.

Innovent Biologics Inc. unveiled for the first time safety and efficacy data of IBI-354, an HER2 monoclonal antibody-camptothecin derivative conjugate that shows promising efficacy signals across a range of advanced solid tumors, during the European Society of Medical Oncology (ESMO) 2024 Congress. An HER2-targeted antibody-drug conjugate developed using Innovent's topoisomerase inhibitor NT3 platform, IBI-354 combines a hydrophilic linker design with a hydrophobic payload to enhance the bystander effect, targeting adjacent antigen-low or negative tumor cells.

Radiopharmaceutical company Telix Pharmaceuticals Ltd. is continuing its buying spree to shore up dominance in the radiopharmaceutical market with its latest acquisition of RLS Radiopharmacies for $250 million to expand its U.S. manufacturing presence and establish a next-generation radiometal production network.

Chengdian (Suzhou) Biopharmaceutical Co. Ltd. has received IND clearance from the FDA, allowing it to initiate a first-in-human phase I trial of CD-001.

For once, the EMA appears to have pipped the U.S. FDA to the post, with Pfizer Inc.’s hemophilia A and B therapy Hympavzi (marstacimab) recommended for approval in Europe on Sept. 20, while the U.S. PDUFA date is set for the fourth quarter of the year.