First TIL Cell Therapy Approval Paves Way For Next Generation

Insights From Iraj Ali, CEO Achilles Therapeutics

Iovance Biotherapeutics' Amtagvi (lifileucel) received approval from the US FDA in February, marking a truly pivotal milestone in the field of solid tumor therapy for certain adult patients with unresectable or metastatic melanoma. As the first approved tumor infiltrating lymphocyte (TIL) therapy, it is set to expedite the regulatory pathway for next-generation products.

FDA Approved typed words on a vintage typewriter
• Source: Shutterstock

The approach behind Amtagvi is a cell therapy conceived by Steve Rosenberg at the National Cancer Institute and has been in development since the late-1980s. The immune system is in constant surveillance and when cancer is detected, lymphocytes (white blood cells) traffic to the tumor to attack and destroy the cancer. The immune cells that enter the tumor are called Tumor Infiltrating Lymphocytes, or TIL, and will include T-cells that recognize distinctive tumor markers (neoantigens) on the cell surface of each person’s cancer. When cancer develops and prevails, the body’s natural TIL can no longer perform their intended function to fight the disease but can be harvested from the tumor and reactivated and reprogrammed as a drug.

About The Author

Iraj Ali has been CEO of Achilles Therapeutics since 2018. Previously he was a managing partner of Syncona Ltd. During his tenure at Syncona he served as an investment partner and board member of Nightstar Therapeutics and Blue Earth Diagnostics. Prior to that he was an associate-principal at McKinsey & Company where he was involved in several major pharmaceutical launches across developed and emerging markets. Ali has a PhD in Biochemistry from Cambridge University.

The approval of the Iovance Biotherapeutics, Inc.'s product is a game changer for researchers and companies developing T-cell-based cancer...

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