Allogene Overland Biopharm Completes Buildout of cGMP Manufacturing Facility in Shanghai to Support the Development of AlloCAR T™ Products in Asia

Rhea-AI Summary

Allogene Overland Biopharm has completed a cutting-edge AlloCAR T manufacturing facility in Shanghai, enabling production for Greater China, Taiwan, South Korea, and Singapore. This milestone supports the accelerated development of AlloCAR T products, addressing the significant need for cell therapies in Asia. The 68,000 square foot GMP facility is designed for scalable and simultaneous production of multiple therapies. The venture aims to enhance access to allogeneic CAR T options and initiate clinical trials for new indications, marking a pivotal step in cancer treatment in the region.

Positive

• Completion of a state-of-the-art GMP facility in Shanghai for AlloCAR T production.
• Facility designed for scalable production, addressing cancer treatment needs in Asia.
• Opportunity to initiate clinical trials for new indications and targets.

Negative

• None.

• GMP Site Designed to Enable Potential Clinical and Commercial Production of AlloCAR T™ Products for Patients in Greater China, Taiwan, South Korea and Singapore
  

SOUTH SAN FRANCISCO, Calif., Oct. 31, 2022 (GLOBE NEWSWIRE) -- Allogene Overland Biopharm (Allogene Overland), a joint venture created by Overland Pharmaceuticals and Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today announced it has completed the buildout of its state-of-the-art AlloCAR T manufacturing facility in Shanghai, China.

“This is an extraordinary milestone,” said Shuyuan Yao, Ph.D, Chief Executive Officer of Allogene Overland. “Our state-of-the-art facility will allow us to accelerate the development of AlloCAR T products licensed from Allogene, the world’s leading allogeneic CAR T company, and ultimately, to play a critical role in bringing off-the-shelf cell therapy to China and other Asian Pacific markets.”

The 68,000 square foot GMP facility utilizes a flexible modular design suitable for all types of cell therapy production. This scalable approach allows for simultaneous manufacturing of several AlloCAR T products, is aimed at addressing the unmet need of patients with cancer in Asia.

“We recognize that autologous CAR T therapies face great hurdles to adoption in China where the population is large, diverse and geographically disperse. Not only does this new manufacturing facility in Shanghai pave the road for our joint venture’s ability to serve the growing number of patients who may benefit from allogeneic CAR T therapies, it affords us the opportunity to launch clinical trials for new indications and against new targets,” said Alison Moore, Ph.D., Chief Technical Officer of Allogene and member of the Board of Directors of Allogene Overland Biopharm.

Allogene Overland Biopharm’s pipeline is focused on the development, manufacturing, and commercialization of specific Allogene candidates targeting BCMA, CD70, FLT3, and DLL3 in the licensed territories.

About Allogene Overland Biopharm
Allogene Overland Biopharm, a joint venture created by Overland Pharmaceuticals and Allogene Therapeutics, is dedicated to accelerating the global development of AlloCAR T™ therapies for patients with hematologic malignancies and solid tumors in China and other Asian Pacific territories.

About Overland Pharmaceuticals
Overland Pharmaceuticals is building a fully integrated biopharma company with a mission to bring innovative medicines to underserved patients in Asia and around the world. By leveraging its resources, global network, and local expertise across the biopharma ecosystem in Asia, Overland is establishing a portfolio of differentiated therapeutic candidates in a few carefully selected therapeutic areas. Through formative partnerships, Overland will move forward the development and commercialization of the most promising advances in medicine. www.overlandpharma.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: Allogene Overland’s ability to manufacture, develop or commercialize any AlloCAR T product candidates, including the ability to secure raw materials and implement a manufacturing process for any AlloCAR T product candidates and the ability to obtain any regulatory clearance for initiating any clinical trial in the licensed territories; and the potential benefits of AlloCAR T. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the Securities and Exchange Commission (SEC), including without limitation in its Form 8-K filed on September 21, 2022, Form 8-K filed on October 6, 2022 and Form 10-Q for the quarter ended June 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.

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

Jessica Bernstein
Senior Manager, Corporate and Internal Communications
(310) 781-0577
Jessica.Bernstein@allogene.com

FAQ

What is the significance of the Allogene Overland Biopharm facility completion?

The completion of the AlloCAR T manufacturing facility in Shanghai is significant as it enables accelerated production and development of CAR T cell therapies for patients in Greater China and other Asian markets.

How large is the Allogene Overland Biopharm GMP facility?

The GMP facility spans 68,000 square feet, accommodating flexible and scalable production of multiple AlloCAR T products.

What regions will benefit from the AlloCAR T manufacturing facility?

The facility will serve Greater China, Taiwan, South Korea, and Singapore, addressing the unmet medical needs of cancer patients in these regions.

What are the aims of Allogene Overland Biopharm's pipeline?

The pipeline focuses on developing and commercializing AlloCAR T therapies targeting specific cancer markers, such as BCMA, CD70, FLT3, and DLL3.

When was the Allogene Overland facility completed?

The Allogene Overland Biopharm facility was completed on October 31, 2022.