Kite Receives U.S. FDA Approval of New State-of-the-Art CAR T-Cell Therapy Manufacturing Facility in Maryland

Rhea-AI Summary

Kite, a Gilead Company (GILD), has received FDA approval for its new CAR T-cell therapy manufacturing facility in Frederick, Maryland. This site expands Kite's capacity by 50%, enhancing its ability to meet increasing patient demand for CAR T-cell therapies. Kite’s global manufacturing network, which includes facilities in Southern California and Amsterdam, aims to provide high-quality, individualized cancer treatments for difficult-to-treat blood cancers. Kite expects to employ over 400 staff at the Maryland site by the end of 2022.

Positive

• FDA approval for new CAR T-cell therapy facility in Maryland.
• 50% increase in manufacturing capacity to meet patient demand.
• Strengthening of Kite's global CAR T-cell therapy manufacturing network.
• Individualized patient treatments with a 96% success rate in timely delivery.

Negative

• Potential risks related to timely production and delivery of therapies.
• Dependence on collaborations for next-gen cell therapies.

-- Kite’s Global CAR T-Cell Therapy Manufacturing Network Increasing Capacity by 50% to Meet Patient Demand for New Cancer Therapies

-- Scalable and Adaptable Facility Provides Flexibility for Current and Future Cell Therapy Innovation

SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved commercial production at the company's new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer.

The Maryland site joins Kite’s existing manufacturing facilities in Southern California and Amsterdam, Netherlands to form the largest, dedicated in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing. With today’s announcement, and through a variety of optimization efforts across Kite’s global CAR T-cell therapy manufacturing network, Kite estimates network capacity will be increased by 50%, enabling more patients to be served now and in the future.

“The FDA approval of our Maryland site marks an important milestone within our global CAR T-cell therapy manufacturing network, and will enable us to significantly expand our production capacity and further strengthen our ability to meet the needs of people living with difficult-to-treat blood cancers,” said Christi Shaw, Chief Executive Officer of Kite. “Manufacturing is central to every decision we make at Kite. Our teams hold patients’ cells in their hands every day, which could mean the difference between getting a chance to live or possibly losing their battle with cancer. It must be fast and extremely high quality to give patients the best outcome.”

CAR T-cell therapies are individually manufactured for each patient using their own T-cells extracted from their white blood cells. The patient’s T-cells are sent to Kite’s manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR) to recognize, attack and destroy their cancer cells. Once the individualized therapy is created for a patient, the cells are carefully preserved, packed and sent back to the hospital to be infused back into the patient. Unlike most cancer treatments, CAR T-cell therapy is a one-time treatment, available through authorized treatment centers (ATCs), or hospitals, that have experience with CAR T-cell therapy. Kite therapies are available at over 275 ATCs around the world, including more than 110 leading cancer hospitals in the U.S.

Kite began construction of the 275,000 square foot facility in Maryland on 20 acres in 2019. The site has unfinished space to add future capacity, which will allow Kite to accommodate potential new scientific and technological advances in the field of cell therapy. The new Maryland facility is purpose-built for cell therapy, incorporating learnings from across the Kite manufacturing network as well as incorporating automation for some previously manual processes, allowing more therapies to be produced to meet growing patient demand.

“As the global leader in cell therapy, it is important to keep innovating as manufacturing in cell therapy is unlike anything else in the biologics or pharmaceutical space – each production run is made to order for one patient – and we do it at scale, with a 96% success rate in returning our specialized treatments on time and to specification,” said Charles Calderaro, Kite’s Global Head of Technical Operations. “Manufacturing quality, reliability, and speed are critically important to us as we know patients are waiting. Our median cycle time is industry leading at 16 days in the U.S., from apheresis to finished product, which includes many processes that are heavily regulated for safety.”

The company is invested in the future of the cell therapy workforce and anticipates having more than 400 employees working at the Maryland site by the end of 2022. The site is also committed to training and developing the region’s cell therapy talent through partnerships with local academic institutions as well as community and government organizations.

Kite’s manufacturing and process development expertise in cell therapy make it a partner of choice, and this expertise is a key component of partnership pipeline deals for the next generation of cell therapies, including previously announced deals with Appia Bio and Shoreline Biosciences.

To learn more about how cell therapy is manufactured, and a look inside the new Maryland facility please click here.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kite’s singular focus is cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Kite’s ability to increase its CAR T-cell therapy manufacturing capacity, timely manufacture and deliver such therapies or produce an amount of supply sufficient to satisfy demand for such therapies; Kite’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all; the possibility of unfavorable results from ongoing or additional clinical trials; Kite’s ability to receive regulatory approvals in a timely manner or at all, and the risk that any such approvals may be subject to significant limitations on use; the risk that CAR T-cell therapy will not be broadly accepted by physicians, patients, hospitals, cancer treatment centers, payers and others in the medical community; Kite’s ability to realize the potential benefits of collaborations, including those with Appia Bio and Shoreline Biosciences; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.

Kite, the Kite logo, and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

For more information on Kite, please visit the company’s website at www.kitepharma.com. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220419005631/en/

Jacquie Ross, Investors

investor_relations@gilead.com

Tracy Rossin, Media

trossin@kitepharma.com

Source: Gilead Sciences, Inc.

FAQ

What does Kite's new manufacturing facility produce?

The facility produces CAR T-cell therapy used to treat blood cancers.

How much will Kite's manufacturing capacity increase?

Kite's capacity will increase by 50% with the new Maryland facility.

What is the significance of Kite's FDA approval?

The FDA approval allows Kite to commercially produce CAR T-cell therapies, enhancing treatment availability.

How does CAR T-cell therapy work?

CAR T-cell therapy involves modifying a patient's T-cells to attack their cancer cells, producing individualized treatment.

Where are Kite's manufacturing facilities located?

Kite has manufacturing facilities in Maryland, Southern California, and Amsterdam.