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Allogene Appoints Zachary J. Roberts, M.D., Ph.D. as Executive Vice President of Research & Development

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Allogene Therapeutics announced the appointment of Zachary J. Roberts, M.D., Ph.D., as Executive Vice President of Research and Development. This key leadership change follows the resignation of Rafael Amado, M.D. Dr. Roberts brings extensive experience from Instil Bio and Kite Pharma, where he played a crucial role in developing CAR T therapies. Allogene aims to expedite its pipeline, highlighted by recent positive clinical data for its AlloCAR T candidates like ALLO-501A for large B cell lymphoma. The company is set to initiate pivotal trials in 2023, including the EXPAND and ALPHA2 trials.

Positive
  • Appointment of Zachary J. Roberts expected to enhance R&D efforts.
  • Recent clinical data shows AlloCAR T candidates may induce deep and durable responses.
  • Plans to initiate pivotal Phase 2 trials for ALLO-501A and ALLO-715 in 2023.
Negative
  • Resignation of Rafael Amado raises concerns about leadership continuity.

Cell Therapy Veteran and Former Kite Pharma Clinical Leader to Head Development of Expanding Portfolio of Allogeneic CAR T Product Candidates

SOUTH SAN FRANCISCO, Calif., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today announced the appointment of Zachary J. Roberts M.D., Ph.D. to Executive Vice President of Research and Development. The hiring of Dr. Roberts, who previously held clinical leadership roles at Instil Bio and Kite Pharma, underscores the Company’s commitment to rapidly advancing its pipeline following recent clinical data illustrating the potential of its AlloCAR T product candidates to induce deep and durable responses. Dr. Roberts will assume the responsibilities of Rafael Amado, M.D. who has resigned to pursue other opportunities. Arun Balakumaran, M.D., Chief Medical Officer and Barbra Sasu, Ph.D., Chief Scientific Officer will report to Dr. Roberts.

“Our R&D Showcase demonstrated that we are nearing a key inflection point in the field of cell therapy. Our Phase 1 data support the opportunity to bring a first-in-class product to market with ALLO-501A for the treatment of large B cell lymphoma,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “Success in this endeavor requires a special skill set, including a relentless drive to accelerate and innovate. Having worked alongside Zach at Kite, I know Zach embodies that mindset, and I am thrilled to have him join the Allogene team as we advance multiple product candidates through development.”

Dr. Roberts is a trained immunologist and a board certified oncologist with extensive experience in clinical oncology, including the development of cell therapies. Prior to joining Allogene, Dr. Roberts was Chief Medical Officer of Instil Bio where he led development of both clinical and pre-clinical programs. Prior to that, Dr. Roberts held various roles of increasing responsibility at Kite Pharma (acquired by Gilead in 2017), where he was instrumental in the development and execution of the ZUMA trials across multiple indications for Yescarta®, the first autologous CAR T therapy approved for non-Hodgkin’s lymphoma. He holds an M.D. and Ph.D. in immunology from the University of Maryland and completed clinical and post-graduate training at Massachusetts General Hospital and the Dana-Farber Cancer Institute.

“My years of experience in the field of cell therapy have convinced me that an allogeneic approach is required to deliver the full potential of CAR T to patients in need,” said Dr. Roberts. “The recent datasets presented by Allogene, including the potential to deliver deep and durable responses, have bolstered my belief and passion in this approach. I am excited to work again with some of the pioneers of cell therapy – both at Allogene and clinical trial investigators – as we bring a new treatment modality and a new hope to patients.   

Dr. Chang also recognized the role played by Dr. Amado, “We appreciate Rafael’s efforts to advance pipeline candidates and validate our unique platform approach to AlloCAR T. We wish him well as he continues to pursue his passion of developing anti-cancer therapies.”

In October 2022, the Company initiated the industry’s first potentially pivotal Phase 2 allogeneic CAR T clinical trial (ALPHA2 trial) with ALLO-501A in patients with relapsed/refractory (r/r) large B cell lymphoma (LBCL). In early 2023, the Company expects to initiate the potentially pivotal Phase 2 EXPAND trial, which is intended to demonstrate the contribution of ALLO-647 to the standard fludarabine/cyclophosphamide lymphodepletion regimen, as well as advance Phase 3 readiness for a second line trial in LBCL later in the year. The Company is also planning a potentially pivotal Phase 2 trial for ALLO-715 in r/r multiple myeloma (MM), including planned regulatory discussions, optimizing the manufacturing process and transitioning manufacturing of ALLO-715 to the Company’s own manufacturing facility, Cell Forge 1. Additionally, the Company continues to enroll patients in the Phase 1 TRAVERSE trial with ALLO-316 for the treatment of advanced renal cell carcinoma.

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. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell 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 Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
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," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "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 and ability to progress the ALPHA2, EXPAND, UNIVERSAL, and TRAVERSE trials; the likelihood of success of the ALPHA2 Phase 2 trial, which is based on limited data from the ALPHA Phase 1 trials across two different product candidates and various doses of ALLO-501 or ALLO-501A; advancing to a Phase 2 UNIVERSAL trial; clinical outcomes, which may materially change as more patient data become available; the ability to manufacture AlloCAR T™ products and optimize manufacturing, with consistent and reproducible clinical outcomes; the ability to enroll patients in clinical trials; the potential for Allogene’s product candidates to be approved; and the potential benefits of AlloCAR T products. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the SEC, including without limitation in its Form 8-K filed on November 29, 2022 and under the “Risk Factors” heading of its Form 10-Q for the quarter ended September 30, 2022. 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.
Yescarta® is a registered trademark of Kite Pharma, Inc., a Gilead Company

Allogene’s AlloCAR T™ programs utilize the Cellectis TALEN® technologies. ALLO-501 and ALLO-501A are anti-CD19 products being jointly developed under a collaboration agreement between Servier and Allogene based on an exclusive license granted by Cellectis to Servier. Servier grants to Allogene exclusive rights to ALLO-501 and ALLO-501A in the U.S. The anti-BCMA and anti-CD70 AlloCAR T programs are licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to these AlloCAR T programs.

Allogene Media/Investor Contact:
Christine Cassiano
Chief Communications Officer
(714) 552-0326
Christine.Cassiano@allogene.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/09b44209-6e0b-4cba-9d3c-f5212ddb36e9


FAQ

Who is the new head of R&D at Allogene Therapeutics?

Zachary J. Roberts, M.D., Ph.D., has been appointed as the Executive Vice President of Research and Development.

What is the significance of Dr. Roberts' appointment at Allogene?

His experience in cell therapy and leadership roles at Kite Pharma and Instil Bio is expected to accelerate Allogene's development efforts.

What are the upcoming clinical trials for Allogene's CAR T products?

Allogene plans to initiate the EXPAND and ALPHA2 pivotal trials in 2023.

What is the status of Allogene's product candidates?

Recent clinical data supports the potential of Allogene's AlloCAR T candidates to achieve significant therapeutic responses.

Allogene Therapeutics, Inc.

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Biotechnology
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