Zelluna ASA has submitted a clinical trial application (CTA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for ZI-MA4-1 (ZIMA-101), the company’s lead candidate. ZI-MA4-1 is a novel MAGE-A4-targeting T-cell receptor-natural killer (TCR-NK) therapy.

Vycellix Inc. has successfully completed preclinical development for its universal cell engineering platform (VY-UC) and will now seek clinical trial clearance in Sweden to begin a phase I study of VNK-101, an allogeneic natural killer (NK) cell therapy engineered with VY-UC for relapsed or refractory multiple myeloma.

Shares of San Diego-based Capricor Therapeutics Inc. (NASDAQ: CAPR) closed Dec. 3 at $29.96, up $23.60, or 371%, as investors cheered top-line data from the pivotal phase III Hope-3 trial testing cell therapy deramiocel in Duchenne muscular dystrophy.

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.