Allogene Therapeutics and Arbor Biotechnologies Announce Global Gene Editing Licensing Agreement to Support Advancement of Next-Generation Allogeneic CAR T Platform in Autoimmune Disease

• Allogene’s AlloCAR T™ Autoimmune Disease Platform Leverages Arbor’s CRISPR Gene-Editing Technology
  
• First Allogeneic CAR T Phase 1 Clinical Trial in Autoimmune Disease Expected to Initiate in Early 2025

SOUTH SAN FRANCISCO, Calif. and CAMBRIDGE, Mass., March 12, 2024 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T^™) products for cancer and autoimmune disease, and Arbor Biotechnologies, Inc. (“Arbor”), a biotechnology company discovering and developing the next generation of genetic medicines, today announced a non-exclusive, global gene editing licensing agreement for use of Arbor’s proprietary CRISPR gene-editing technology in Allogene’s next generation AlloCAR T platform for the treatment of autoimmune disease (AID).

“The potential for CAR T as a therapeutic option for autoimmune disease has captured the collective imagination of the scientific community,” said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. “Accordingly, this excitement created a new field for CAR T that has become quickly crowded, making differentiation key for future success. This agreement provides us access to Arbor’s proprietary gene-editing technology and know-how, allowing us to develop what we believe will be the most effective and broadly accessible CAR T approach for the treatment of autoimmune disease.”

Allogene has applied its deep understanding of CAR T research and development to design next-generation allogeneic CAR T investigational products with a goal of reduced or chemotherapy-free conditioning that the Company believes can sustain the scale of the AID market while also meeting the unique requirements for these patients where they seek care. Allogene’s first AID AlloCAR T investigational product is expected to enter Phase 1 clinical trials in early 2025.

“Our strategy has long been to align ourselves with industry leaders who are working to harness the power of gene editing to change treatment paradigms and improve patient outcomes,” said Devyn Smith, Ph.D., Chief Executive Officer of Arbor. “We look forward to our collaboration with Allogene as they leverage our extensive gene-editing technologies to develop novel, differentiated allogeneic CAR T therapeutics for autoimmune diseases.”

About Arbor Biotechnologies
Arbor Biotechnologies^® is a next-generation gene editing company based in Cambridge, Mass. Combining the promise of CRISPR with advanced computational AI-driven discovery, high-throughput screening, and robust protein engineering approaches, our scientific co-founders Feng Zhang and David Walt laid the groundwork for our proprietary discovery engine, that has yielded an extensive portfolio of novel genomic editors. We envision a future of gene editing that extends beyond simple knockdowns to include reverse transcriptases, nuclease excisions and large insertions. This affords us the potential to treat a broad spectrum of patients, from those with ultra-rare to the most common genetically defined diseases. Guided by a deep understanding of the molecular basis of disease and our access to a unique suite of optimized genomic editors, we are rapidly advancing our development programs with an initial focus on genetically defined liver-mediated and CNS diseases. As we advance toward the clinic with our first therapeutic candidate in primary hyperoxaluria type I, we look to expand our strategic partnerships around in vivo genomic editing across multiple therapeutic areas and ex vivo cell therapy programs to broaden the reach of our novel gene editing technologies. For more information, visit arbor.bio.

About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.

Cautionary Note on Forward-Looking Statements for Allogene
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as “predicts,” “projects,” “believes,” “potential,” “proposed,” “advance,” “making,” “continue,” “estimates,” “anticipates,” “expects,” “envision,” “plans,” “intends,” “look to,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the timing of filing Investigational New Drug applications relating to autoimmune disease and the progress and success of such clinical program; the ability to reduce or eliminate chemotherapy conditioning in autoimmune disease; the potential for our product candidates to be approved; the potential benefits of AlloCAR T products; the ability of our product candidates to treat autoimmune disease; our ability to broaden patient access to CAR T therapy; the extent to which our clinical trials will support regulatory approval of our product candidates; the potential for off-the-shelf CAR T products; our ability to deliver cell therapy on-demand, more reliably, and at greater scale to more patients. Various factors may cause material differences between Allogene’s expectations and actual results, including, risks and uncertainties related to: our product candidates are based on novel technologies, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval or limit their commercial potential; the extent to which the Food and Drug Administration disagrees with our clinical or regulatory plans or the import of our clinical results, which could cause future delays to our clinical trials, including initiation of clinical trials, or require additional clinical trials; we may encounter difficulties enrolling patients in our clinical trials; we may not be able to demonstrate the safety and efficacy of our product candidates in our clinical trials, which could prevent or delay regulatory approval and commercialization; and challenges with manufacturing or optimizing manufacturing of our product candidates. These and other risks are discussed in greater detail in Allogene’s filings with the SEC, including without limitation under the “Risk Factors” heading in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2023. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

AlloCAR T™ is a trademark of Allogene Therapeutics, Inc.

Allogene Media/Investor Contacts:
Christine Cassiano
EVP, Chief Corporate Affairs & Brand Strategy Officer
Christine.Cassiano@allogene.com

Leslie Bryant
Senior Communications Consultant
Leslie.Bryant@allogene.com

Maddie Goldstein
Senior Manager, Corporate Communications
Madeleine.Goldstein@allogene.com

Arbor Biotechnologies Contact:
Peg Rusconi
Verge Scientific Communications
Peg.rusconi@vergescientific.com