Cancer, B-cell lymphoma, Diffuse large B cell lymphoma
DTILPrecision BioSciencesCatalyst overview
Research summary
This catalyst tracks a Phase 1 update for Azer-cel (PBCAR0191) (azercabtagene zapreleucel) in Cancer, B-cell lymphoma, Diffuse large B cell lymphoma. The expected timing is based on the latest available company guidance and may change.
Led by TG Therapeutics. 7/27/23- Type B meeting w/ FDA. 8/15/23- Sold global rights to Imugene. 1/9/24 License deal w/ TG therapeutics. 3/26/25- Actively enrolling participants. 11/03/25:- Updated Phase 1b efficacy data showed high response rates, including complete responses, in relapsed/refractory and CAR T-naïve lymphoma patients; enrollment is ongoing and a Type C FDA meeting is planned to discuss potential pivotal study design. 01/12/26:- Imugene gained FDA alignment to advance azer-cel into pivotal lymphoma study; autoimmune Phase 1 MS enrollment ongoing; milestones payable. 03/12/26:- Imugene received FDA pivotal guidance; TG milestone triggered; Phase 1 MS data expected H2 2026 with additional autoimmune studies starting. 05/05/26:- Azer-cel oral data presentation at ASCO 2026 in lymphoma; TG paid $7.5M milestone. 08/06/26:- FDA registrational guidance received; ASCO data showed 50%-100% response rates across six subtypes.
Verification
Confirm timing and program details against the company announcement or filing.