![](https://www.clinicaltrialsarena.com/wp-content/uploads/sites/22/2024/08/TG-Therapeutics-shutterstock_2340940201-430x241.jpg)
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.
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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
![](/wp-content/themes/goodlife-wp-B2B/assets/images/company-profile-unit.png)
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataTG 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.