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Allogene Therapeutics Unveils Cell Forge 1, a Uniquely Designed Manufacturing Facility to Deliver AlloCAR T™ Products

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Allogene Therapeutics has unveiled its new 136,000-square-foot cGMP manufacturing facility, Cell Forge 1, in Newark, California. The facility is operational and prepares for the pivotal trial of ALLO-501A targeting relapsed/refractory Non-Hodgkin Lymphoma. Designed for flexibility, it supports clinical trials and potential commercial production of AlloCAR T™ products. The facility prioritizes sustainability, fully powered by renewable energy, aiming for LEED Gold certification. This initiative is significant as Allogene expands its pipeline and regulatory filings while enhancing manufacturing capabilities.

Positive
  • Operational Cell Forge 1 facility supports pivotal trial for ALLO-501A.
  • Flexible design enables scalable production of AlloCAR T™ products.
  • Environmentally sustainable, 100% powered by renewable sources, targeting LEED Gold certification.
Negative
  • None.
  • Interactive Experience Designed to Showcase the 136,000sf cGMP Facility Located in Newark, California
  • Cell Forge 1 is Operational in Preparation for the Company’s First Pivotal Trial with ALLO-501A for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma
  • Modular Facility Enables Flexibility and Control of Clinical Trial and Potential Commercial Production of Off-the-Shelf AlloCAR T™ Products
  • Environmentally Sustainable and 100% Powered by Renewable Electricity

SOUTH SAN FRANCISCO, Calif., April 14, 2022 (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 virtual unveiling of its manufacturing facility, Cell Forge 1 (“CF1”), located in Newark, California. The 136,000-square-foot facility is designed to support clinical trial and potential commercial production and worldwide distribution of allogeneic CAR T cell products for blood cancers and solid tumors. The virtual platform, designed to create an interactive and engaging CF1 virtual experience, includes welcome remarks from Allogene’s President, Chief Executive Officer and Co-Founder, David Chang, M.D., Ph.D., corporate and scientific videos, a 360° virtual tour of the facility, and a patient gallery.

A Media Snippet accompanying this announcement is available by clicking on the image or link below:

Allogene Therapeutics Cell Forge 1 Media Snippet: Allogene Therapeutics Cell Forge 1 Media Snippet

“Cell Forge 1 is a critical piece of our strategy for revolutionizing CAR T cancer therapy. As we prepare for our first AlloCAR T pivotal trial in mid-2022, we will draw on the capabilities of this state-of-the-art facility to meet product demand while maintaining important quality controls,” said Alison Moore, Ph.D., Chief Technical Officer of Allogene. “We believe this is an ideal time to bring the facility online. Cell Forge 1 is uniquely designed to grow with Allogene as we expand our pipeline, prepare for future regulatory filings, and scale up production for potential commercial distribution.”

CF1 includes modular production suites, which are flexible and adaptable for growth. It also includes space for quality control testing, an environmental testing lab, and an advanced data system infrastructure, as well as administrative and warehouse space.

Environmental sustainability was a key element of building design, including features that allow for energy savings, water conservation, and reduced greenhouse gas emissions. CF1 is designed to be a fully electric facility 100% powered by renewable solar and wind power aimed at earning LEED Gold certification for design and operation.

“In designing Cell Forge 1 we sought to prioritize adaptability, sustainability, and collaboration. CF1 is future-facing and intended to support scalable production of AlloCAR T cells,” said Ben Beneski, Vice President and CF1 Site Head at Allogene. “We expect the facility to enhance innovation across all facets of manufacturing, allowing Allogene to deliver potential lifesaving cancer treatments to more patients. We are grateful to everyone, both at Allogene and in the community, who brought this vision to reality.”

External partners and supporters who were critical in the construction and development of CF1: the City of Newark, Dome Construction, CRB, RIOS, and Savills.

Located in the East Bay, Cell Forge 1 is in proximity to Allogene Therapeutics’ South San Francisco headquarters, allowing for close exchange among, manufacturing, process development, research and corporate teams. To learn more about what this new facility means for the future of Allogene and the potential impact it will have on those living with cancer visit the Cell Forge 1 Manufacturing hub on Allogene’s website. The video and images embedded into this press release above are also available on the site: www.cf1.com.

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 AlloCAR T™ trials, including advancing to the Phase 2 portion of the ALPHA2 trial, and commercialize any AlloCAR T™ products; the ability to manufacture AlloCAR T™ products; the timing and ability to obtain agreement with the U.S. Food and Drug Administration to use ALLO-501A manufactured at CF1 for use in the ALPHA2 trial; 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 10-K for the year ended December 31, 2021. 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 Contact:
Christine Cassiano
Chief Communications Officer
(714) 552-0326
Christine.Cassiano@allogene.com


FAQ

What is the significance of the Cell Forge 1 facility for Allogene Therapeutics?

The Cell Forge 1 facility is crucial for supporting clinical trials and potential commercial production of AlloCAR T™ products, enhancing Allogene's operational capacity.

When is the pivotal trial for ALLO-501A expected to start?

The pivotal trial for ALLO-501A is scheduled to begin in mid-2022.

How does the Cell Forge 1 facility impact Allogene's production capabilities?

Cell Forge 1's flexible design allows for adaptable and scalable production, essential for meeting future product demands.

What sustainability measures are incorporated in the Cell Forge 1 facility?

The facility is designed to be fully electric, powered by renewable solar and wind energy, aiming for LEED Gold certification.

What is the size of the Cell Forge 1 facility?

The Cell Forge 1 facility spans 136,000 square feet.

Allogene Therapeutics, Inc.

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Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
SOUTH SAN FRANCISCO