WuXi Advanced Therapies Receives FDA Approval to Manufacture Iovance's AMTAGVI™ (lifileucel) for Advanced Melanoma

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WuXi Advanced Therapies Receives FDA Approval for AMTAGVI, a One-Time T Cell Therapy for Solid Tumor Cancer

Insights

Oncology Doctor

The FDA's accelerated approval of AMTAGVI marks a significant advancement in oncology, particularly for the treatment of advanced melanoma. This therapy represents a new frontier in personalized medicine, as it's tailored to the individual's tumor profile. Given that it targets patients who have previously been treated with PD-1 inhibitors and, in some cases, BRAF and MEK inhibitors, it offers a novel option for those who may have limited treatments available.

The one-time administration aspect of AMTAGVI could potentially translate into a different side effect profile compared to therapies requiring continuous dosing. Furthermore, the approval for a solid tumor is a noteworthy achievement, as most T cell therapies have been concentrated on hematological malignancies. The long-term benefits and potential side effects of such a therapy will be critical to monitor, as the landscape of melanoma treatment may be significantly altered.

Medical Research Analyst

From a research and development perspective, the partnership between Iovance and WuXi ATU emphasizes the growing trend of collaboration between biotech firms and contract development and manufacturing organizations (CDMOs). This relationship allows for streamlined development and manufacturing processes, which can be crucial in the expedited delivery of novel therapies to market.

The analytical testing and manufacturing capabilities of WuXi ATU's Philadelphia site are central to the commercialization of AMTAGVI. The proximity of WuXi ATU to Iovance's Cell Therapy Center could facilitate efficient production and distribution logistics, potentially reducing time-to-market for the therapy and enabling rapid scale-up if demand increases.

Market Research Analyst

The approval of AMTAGVI and its subsequent manufacturing and testing at WuXi ATU's site could have implications for the biotech sector, particularly in the niche of individualized T cell therapies. For investors, the focus may shift towards companies that demonstrate capabilities in personalized medicine, especially those that cater to unmet medical needs.

Iovance's stock performance (NASDAQ: IOVA) might experience volatility as the market assesses the commercial success of AMTAGVI. Factors such as adoption rate, pricing strategy and reimbursement policies will play significant roles. Moreover, the approval could influence competitor strategies, potentially accelerating the development of similar therapies or prompting strategic partnerships akin to that of Iovance and WuXi ATU.

AMTAGVI is the first and only one-time, individualized T cell therapy to receive U.S. 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 Philadelphia site to begin the analytical testing and manufacturing of AMTAGVI for Iovance, which received FDA accelerated approval of its Biologics License Application (BLA) on February 16, 2024.

AMTAGVI is a tumor-derived autologous 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 one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.

With this announcement, WuXi ATU's Philadelphia site becomes the first U.S. external manufacturing site and the first third-party contract testing, development, and manufacturing organization (CTDMO) to be approved by the FDA to support the commercial manufacturing and release of an individualized T cell therapy for a solid tumor cancer.

"We congratulate Iovance on this major milestone in their quest to address unmet patient needs in the treatment of advanced melanoma. WuXi ATU has partnered with Iovance since 2015, and we are thrilled to help them through each step of the drug development pipeline – from research to clinical manufacturing to FDA approval," said Edward Hu, Chief Executive Officer of WuXi ATU and Vice Chairman of WuXi AppTec. "We are proud of our track record of enabling healthcare innovators to advance medical discoveries and deliver groundbreaking treatments to patients globally." 

Iovance, (NASDAQ: IOVA) is headquartered in San Carlos, California with an FDA-approved built-to-suit custom manufacturing facility, the Iovance Cell Therapy Center (iCTC), adjacent to WuXi ATU in the Navy Yard Philadelphia. The company is committed to innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies, including gene-edited cell therapies, for patients with cancer.

"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 breakthrough to patients with advanced solid tumors," said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. "Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients. WuXi ATU has partnered with us to manufacture this cell therapy for close to a decade. It is a great benefit to both Iovance and the healthcare community to have a contract testing, development, and manufacturing partner adjacent to our facilities. Working together, our teams can make a meaningful difference for patients."

About Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics (NASDAQ: IOVA) aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer. We are pioneering a transformational approach to cure 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 across multiple solid tumors. Iovance's AMTAGVI™  is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer. For more information, please visit www.iovance.com.

About WuXi Advanced Therapies (WuXi ATU)

As the advanced therapies business unit of WuXi AppTec, WuXi Advanced Therapies is a Contract Testing, Development and Manufacturing Organization (CTDMO) that offers advanced platforms and end-to-end solutions that enable the discovery, development, testing, manufacturing, and commercialization of cell and gene 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 across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and healthcare industry around the world to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec's integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, and cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2023 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated."

CONTACTS

WuXi Advanced Therapies 
Amy Lamperti
Executive Director, Global Marketing
215-218-7100
amy.lamperti@wuxiapptec.com 

WuXi AppTec
Davy Wu
Executive Director, Brand & Corporate Communications
mediainquiries@wuxiapptec.com

Iovance Biotherapeutics, Inc:
Sara Pellegrino, IRC
Senior Vice President, Investor Relations & Corporate Communications
650-260-7120 ext. 264
Sara.Pellegrino@iovance.com

Jen Saunders
Director, Investor Relations & Public Relations
267-485-3119
Jen.Saunders@iovance.com

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SOURCE WuXi AppTec

FAQ

What is the FDA approval status for AMTAGVI by WuXi Advanced Therapies?

AMTAGVI, a one-time individualized T cell therapy, has received FDA approval for the treatment of solid tumor cancer.

What is the indication for AMTAGVI therapy?

AMTAGVI is indicated for the treatment of adult patients with unresectable or metastatic melanoma who have been previously treated with a PD-1 blocking antibody.

Which company received accelerated approval of its Biologics License Application for AMTAGVI?

Iovance, the partner of WuXi Advanced Therapies, received FDA accelerated approval for AMTAGVI.

Where is the analytical testing and manufacturing of AMTAGVI set to begin?

The testing and manufacturing of AMTAGVI will begin at WuXi ATU's Philadelphia site.

Who is the Chief Executive Officer of WuXi ATU and Vice Chairman of WuXi AppTec?

Edward Hu serves as the Chief Executive Officer of WuXi ATU and Vice Chairman of WuXi AppTec.