TG Therapeutics plans to initiate the Phase I trial this year to explore the potential of azer-cel in MS treatment. Credit: CC7 / Shutterstock.

Precision BioSciences’ partner TG Therapeutics has obtained clearance from the US Food and Drug Administration (FDA) for an investigational new drug (IND) application to commence Phase I clinical trial of Azercabtagene Zapreleucel (azer-cel) for progressive forms of multiple sclerosis (MS).

Azer-cel is a new allogeneic CAR T therapy developed by Precision BioSciences.

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In January this year, Precision entered a licensing agreement with TG Therapeutics, granting it global rights to azer-cel for autoimmune diseases, excluding cancer indications.

As part of the agreement, Precision BioSciences received an upfront payment along with potential near-term economic benefits valued at $17.5m.

Additionally, the company received up to $288m in milestone payments contingent on the achievement of specific clinical, regulatory, and commercial targets.

Furthermore, Precision BioSciences received royalties on net sales, ranging from high-single-digit to low-double-digit percentages.

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TG Therapeutics plans to initiate the Phase I trial this year to explore the potential of azer-cel in MS treatment.

Precision BioSciences CEO Michael Amoroso said: “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.

“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.”

The company’s ARCUS platform is being used for the development of in vivo gene editing therapies for gene edits.

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