Gene editing company Precision BioSciences Inc (Nasdaq:DTIL) announced on Friday that its partner TG Therapeutics has received US Food and Drug Administration (FDA) Investigational New Drug (IND) clearance for Azercabtagene Zapreleucel (azer-cel) to treat progressive multiple sclerosis.

An allogeneic CAR T therapy discovered by Precision, azer-cel is intended for the treatment of autoimmune diseases. TG Therapeutics plans to initiate a phase 1 clinical trial before the end of the year.

Precision BioSciences licensed azer-cel to TG Therapeutics in January 2024 for global rights for automimmune diseases and indications outside of cancer, receiving USD17.5m upfront and potential milestone payments of up to USD288m, plus royalties. While supporting TG Therapeutics' clinical development, Precision BioSciences remains focused on advancing its in vivo gene editing pipeline, including a planned IND or Clinical Trial Application (CTA) submission for PBGENE-HBV for hepatitis B this year.