Vigencell Inc. plans to seek conditional approval in South Korea for VT-EBV-N, an antigen-specific killer T-cell therapy for natural killer T-cell lymphoma, after gaining positive top-line data from a phase II study Nov. 25.
Immunotherapy-focused biotech company LTZ Therapetics Inc. and GSK plc are partnering to develop up to four potential first-in-class myeloid cell engagers using LTZ’s immune-engager platform to target blood cancers and solid tumors.
Fibrobiologics Inc. has received public and private Human Research Ethics Committee (HREC) approvals in Australia for a phase I/II trial evaluating CYWC-628 for the treatment of refractory diabetic foot ulcers.
Antengene Corp. Ltd. has outlined progress in its early-stage pipeline. The company has leveraged its Antengager T-cell engager (TCE) platform for the discovery of multiple investigational programs.
Immunotherapy-focused biotech company LTZ Therapetics Inc. and GSK plc are partnering to develop up to four potential first-in-class myeloid cell engagers using LTZ’s immune-engager platform to target blood cancers and solid tumors.
T-knife Therapeutics Inc. has filed a clinical trial application (CTA) to initiate a phase I trial of TK-6302, a PRAME-targeted T-cell receptor (TCR) T-cell therapy in solid tumors. Pending CTA approval, the ATLAS trial is planned to begin next year.
Captain T Cell GmbH has successfully closed an equity financing round to support its T-cell receptor (TCR) T-cell therapies for solid tumors. The company’s autologous lead program, CTC-127, is a best-in-class TCR T-cell therapy targeting MAGE-A4-positive solid tumors and is expected to enter clinical trials in early 2027.
In an article that reads like informal guidance, U.S. FDA Commissioner Marty Makary and CBER Director Vinay Prasad discussed the criteria for using the agency’s novel plausible mechanism pathway for personalized treatments when a randomized trial isn’t feasible, as well as future uses of the approval path that could expand beyond gene and cell therapies to other biologics and even small molecules.
CEO Lynn Seely said Lyell Immunopharma Inc. is going “full steam ahead” with development of rondecabtagene autoleucel (ronde-cel, also known as LYL-314) amid the excitement of the firm’s latest news: the buy of global rights to LYL-273, an autologous guanylyl cyclase-C-targeted CAR T-cell candidate for metastatic colorectal cancer (mCRC), from Innovative Cellular Therapeutics Inc. (ICT) for an up-front payment of $40 million and 1.9 million shares of Lyell common stock.
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