Precision BioSciences Announces U.S. Patent Trial and Appeal Board Upholds Allogeneic CAR T Patents

October 15, 2020

– Patent Trial and Appeal Board (PTAB) Rules in Favor of Precision BioSciences in Two Patent Interference Proceedings

DURHAM, N.C., Oct. 15, 2020 (GLOBE NEWSWIRE) — Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS^® genome editing platform, today announced that the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) has ruled in favor of Precision BioSciences in two patent interference proceedings that challenged nine U.S. patents owned by Precision.

The patents, which issued in 2018, relate to Precision BioSciences’ allogeneic chimeric antigen receptor (CAR) T cell platform. Specifically, the patents relate to allogeneic CAR T cells produced by inserting a gene encoding a CAR into the T cell receptor (TCR) alpha chain (TRAC) locus, as well as methods of using those cells for cancer immunotherapy. CAR T cells produced using this single-step process have exhibited consistent performance, been manufactured at large scale and reduced cost, and shown to protect patients from graft vs. host disease. In the interference proceedings, a third party argued that it had invented the technology in 2012. The PTAB, however, found that the third-party patent application did not satisfy the written description requirement and rejected these claims while maintaining the claims in all nine of Precision’s patents.

“We are very pleased that the U.S. Patent Trial and Appeal Board quickly rejected this challenge and affirmed Precision’s intellectual property around our patented single-step CAR knock-in/TCR knock-out approach,” said Derek Jantz, Chief Scientific Officer and Co-Founder of Precision. “Although our patent claims encompass the use of any gene editing technology to produce these allogeneic CAR T cells, we believe that ARCUS is the best gene editor for this purpose due to its ability to very efficiently target the insertion of DNA into the genome.”

The proceedings before the PTAB were U.S. Interference Nos. 106,117 and 106,118. The third party has the right to appeal the decisions. The Precision BioSciences patents involved were U.S. Pat. No. 9,889,160, U.S. Pat. No. Patent 9,889,161, U.S. Pat. No. 9,950,010, U.S. Pat. No. 9,950,011, U.S. Pat. No. 9,969,975, U.S. Pat. No. 9,993,501, U.S. Pat. No. 9,993,502, U.S. Pat. No. 10,093,899, and U.S. Pat. No. 10,093,900. Precision BioSciences was represented by Wolf Greenfield & Sacks PC.

About Precision’s Allogeneic CAR T Platform
Precision is advancing a pipeline of cell-phenotype optimized allogeneic CAR T therapies, leveraging fully scaled, proprietary manufacturing processes. The platform is designed to maximize the number of patients who can potentially benefit from CAR T therapy. Precision carefully selects high-quality T cells derived from healthy donors as starting material, then utilizes its unique ARCUS genome editing technology to modify the cells via a single-step engineering process. By inserting the CAR gene at the T cell receptor (TCR) locus, this process knocks in the CAR while knocking out the TCR, creating a consistent product that can be reliably and rapidly manufactured that is designed to prevent graft-versus-host disease. Precision optimizes its CAR T therapy candidates for immune cell expansion in the body by maintaining a high proportion of naïve and central memory CAR T cells throughout the manufacturing process and in the final product.

About Precision BioSciences, Inc.
Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. ARCUS is a highly specific and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Company’s pipeline consists of multiple “off-the-shelf” CAR T immunotherapy clinical candidates and several in vivo gene correction therapy candidates to cure genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences please visit www.precisionbiosciences.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the Company’s CAR T therapies and the success of its one-step genome editing process. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “mission,” “may,” “will,” “would,” “should,” “could,” “target,” “project,” “predict,” “contemplate,” “potential,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to become profitable; our ability to procure sufficient funding and requirements under our current debt instruments; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the success of our programs and product candidates in which we expend our resources; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; our or our collaborators’ ability to identify, develop and commercialize product candidates; pending and potential liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators’ development of product candidates; our or our collaborators’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; our or our collaborators’ ability to advance product candidates into, and successfully design, implement and complete, clinical or field trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; our ability to achieve our anticipated operating efficiencies at our manufacturing facility; delays or difficulties in our and our collaborators’ ability to enroll patients; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data privacy and security regulations and our compliance therewith; the rate and degree of market acceptance of any of our product candidates; the success of our existing collaboration agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate key scientific and management personnel; market and economic conditions; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events effects of the outbreak of COVID-19, or any pandemic, epidemic or outbreak of an infectious disease; insurance expenses and exposure to uninsured liabilities; and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors & Media page of our website at investor.precisionbiosciences.com.

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Investor Contact:
Alex Kelly
Chief Corporate Affairs Officer
[email protected]

Media Contact:
Maurissa Messier
Senior Director, Corporate Communications
[email protected]