– Out licensed allogeneic CAR T azer-cel receives IND clearance from U.S. FDA
DURHAM, NC, USA I August 09, 2024 I 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, today 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.
About Precision BioSciences, Inc.
Precision BioSciences, Inc. is an advanced gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics may enable ARCUS nucleases to drive more intended, defined therapeutic outcomes. Using ARCUS, the Company’s pipeline is comprised of in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit www.precisionbiosciences.com.
The ARCUS® platform is being used to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion (inserting DNA into gene to cause expression/add function), elimination (removing a genome e.g. viral DNA or mutant mitochondrial DNA), and excision (removing a large portion of a defective gene by delivering two ARCUS nucleases in a single AAV).
SOURCE: Precision BioSciences
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– Out licensed allogeneic CAR T azer-cel receives IND clearance from U.S. FDA
DURHAM, NC, USA I August 09, 2024 I 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, today 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.
About Precision BioSciences, Inc.
Precision BioSciences, Inc. is an advanced gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics may enable ARCUS nucleases to drive more intended, defined therapeutic outcomes. Using ARCUS, the Company’s pipeline is comprised of in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit www.precisionbiosciences.com.
The ARCUS® platform is being used to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion (inserting DNA into gene to cause expression/add function), elimination (removing a genome e.g. viral DNA or mutant mitochondrial DNA), and excision (removing a large portion of a defective gene by delivering two ARCUS nucleases in a single AAV).
SOURCE: Precision BioSciences
Post Views: 4,742
