Jan. 9 Quick Takes: Precision deal gets TG entry into autoimmune CAR T race

Plus: Pfizer’s, Genmab’s Tivdak gets priority review for full approval and more from Astellas, Cumulus, Pfizer and Innovent

January 9, 2024 11:35 PM UTC

Through a licensing deal with Precision Biosciences Inc. (NASDAQ:DTIL), TG Therapeutics Inc. (NASDAQ:TGTX) is entering the rapidly growing race to develop CAR T cells for autoimmune indications. TG received exclusive, worldwide rights to develop and commercialize Precision’s lead allogeneic CAR T cell, azercabtagene zapreleucel (azer-cel), in non-oncology indications, joining at least 19 other companies applying CD19-directed CAR Ts to the disease area. The company plans to submit an IND mid-year. Precision will receive $7.5 million in upfront cash and common shock, purchased at a 100% premium to the 30-day VWAP prior to purchase. The biotech will also receive $2.5 million in deferred equity investments, and is eligible for an additional $7.5 in near-term milestones, plus $288 million in additional milestones and high single-digit to low double-digit royalties.

Pfizer Inc. (NYSE:PFE) and Genmab A/S (CSE:GMAB; NASDAQ:GMAB) said FDA granted priority review to their sBLA for Tivdak tisotumab vedotin, which would convert its accelerated approval to full approval. Its PDUFA date is May 9. The antibody-drug conjugate targeting TF has shown an overall survival benefit in a Phase III trial among patients with recurrent or metastatic cervical cancer; it gained accelerated approval in 2021...