Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, gene insertion, and gene excision, announced that its partner TG Therapeutics has received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) Application to investigate Azercabtagene Zapreleucel (azer-cel) in human clinical trials for the treatment of progressive forms of multiple sclerosis. Azer-cel is an experimental allogeneic CAR T therapy discovered by Precision BioSciences and licensed to TG Therapeutics for the treatment of autoimmune diseases. TG Therapeutics anticipates commencing a phase 1 clinical trial in 2024.
“We would like to congratulate TG Therapeutics on receiving IND clearance for azer-cel in patients with progressive multiple sclerosis. We believe the expansion of allogeneic CAR T into autoimmune diseases holds the potential to unlock new therapies for patients living with chronic disease,” said Michael Amoroso, Chief Executive Officer of Precision BioSciences. “We look forward to TG Therapeutics initiating a clinical trial for azer-cel in autoimmune disease as we focus on the advancement of our own wholly owned in vivo gene editing pipeline, including our planned IND and/or Clinical Trial Application (CTA) submission for PBGENE-HBV for hepatitis B this year.”
In January 2024, Precision BioSciences announced a licensing deal with TG Therapeutics for the CAR T therapy azer-cel. In exchange for global rights to azer-cel for automimmune diseases and indications outside of cancer, Precision received upfront and potential near-term economics valued at $17.5 million and up to $288 million in other milestone payments based on achievement of certain clinical, regulatory, and commercial milestones, in addition to high-single-digit to low-double-digit royalties on net sales.
