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-WuXi Advanced Therapies receives FDA approval to manufacture Iovance's AMTAGVI™ (lifileucel) for advanced melanoma
AMTAGVI is the first and only individualized T cell therapy to receive US FDA approval for a solid tumor cancer.
PHILADELPHIA, Feb. 20, 2024 /PRNewswire/ -- WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Drug Administration (FDA) has approved its site of Philadelphia to begin analytical testing and manufacturing of AMTAGVI for Iovance, which received accelerated FDA approval of its Biologics License Application (BLA) on February 16, 2024.
AMTAGVI is an autologous tumor-derived T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody and, if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. AMTAGVI is also the first and only individualized T cell therapy to receive US FDA approval for a solid tumor cancer.
With this announcement, WuXi ATU's Philadelphia site becomes the first US third-party manufacturing site and the first third-party contract test, development and manufacturing organization (CTDMO) approved by the FDA to support manufacturing commercial and the release of an individualized T cell therapy for a solid tumor cancer.
"We congratulate Iovance on this important milestone in their quest to address patients' unmet needs in the treatment of advanced melanoma. WuXi ATU has partnered with Iovance since 2015 and we are delighted to assist them in every step of the drug development process. , from research to clinical manufacturing to FDA approval," said Edward Hu, CEO of WuXi ATU and Vice President of WuXi AppTec. "We are proud of our track record of enabling healthcare innovators to advance medical discoveries and deliver innovative treatments to patients around the world."
Iovance, (NASDAQ: IOVA) is headquartered in San Carlos, California, and operates an FDA-cleared, custom manufacturing facility, the Iovance Cellular Therapy Center (iCTC), adjacent to the WuXi ATU in Navy Yard Philadelphia. The company is committed to the innovation, development and administration of tumor-infiltrating lymphocyte (TIL) cell therapies, including gene-edited cell therapies, for cancer patients.
"The accelerated approval of AMTAGVI™ is the first step in realizing Iovance's ambition to usher in the next generation of cell therapy by bringing this advancement to patients with advanced solid tumors," said Frederick Vogt, Ph.D., J.D., interim CEO and president of Iovance. "Given the significant unmet needs in the advanced melanoma community, we are proud to offer a unique and personalized therapeutic option for these patients. WuXi ATU has partnered with us to manufacture this cell therapy for almost a decade. It is a great benefit both "It is for Iovance and the healthcare community to have a contracted partner for testing, development and manufacturing adjacent to our facilities. Working together, our teams can make a significant difference for patients."
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics (NASDAQ: IOVA) aims to be the global leader in innovation, development and delivery of tumor-infiltrating lymphocyte (TIL) cell therapies for cancer patients. We are pioneering a transformative approach to curing cancer by harnessing the human immune system's ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data in multiple solid tumors. Iovance's AMTAGVI™ is the first T-cell therapy approved by the FDA for a solid tumor indication. We are committed to continued innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for cancer patients. For more information, visit www.iovance.com.
About WuXi Advanced Therapies (WuXi ATU)
As an advanced therapies business unit of WuXi AppTec, WuXi Advanced Therapies is a contract testing, development and manufacturing organization (CTDMO) that provides advanced platforms and end-to-end solutions that enable discovery, development, testing, manufacturing and commercialization of cellular and genetic therapies. Our services and solutions accelerate time to market and support customer programs around the world. For more information, visit www.advancedtherapies.com.
About WuXi AppTec
As a global company with operations in Asia, Europe and North America, WuXi AppTec offers a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and healthcare industries around the world to advance discoveries and deliver innovative treatments to patients. Through its unique business models, WuXi AppTec's end-to-end integrated services include CRDMO (Contract Research, Development and Manufacturing Organization) of chemical drugs, biology discovery, preclinical testing and clinical research services, and CTDMO ( Contract Testing, Development and Manufacturing Organization) of cell and gene therapies, helping clients improve the productivity of advanced healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2023 and its open access platform enables more than 6,000 customers in more than 30 countries to improve the health of those in need and realize the vision that "every medicine can be manufactured and every illness can be treated."
CONTACTS
WuXi Advanced Therapies Amy LampertiDirectora ejecutiva, Marketing global215-218-7100amy.lamperti@wuxiapptec.com
WuXi AppTecDavy WuCEO, Corporate & Brand Communicationsmediainquiries@wuxiapptec.com
Iovance Biotherapeutics, Inc:Sara Pellegrino, IRCSenior Vice President, Investor Relations and Corporate Communications Communications650-260-7120 ext. 264Sara.Pellegrino@iovance.com
Jen SaundersDirector, Investor Relations and Public Relations267-485-3119Jen.Saunders@iovance.com
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