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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from C-Suite Speaks

Podcast: “They Are Able To Keep Their Body”: Medipost On Its Stem Cell Therapy Vision

 

In Vivo spoke with Edward Ahn, CEO of Medipost, a Korean company that has developed stem cell therapies from cord blood, on how they are working across regulatory markets to provide a novel treatment for degenerative diseases.

Podcast: Acuitas CSO On CRISPR Delivery Breakthrough And Next-Gen Lipid Nanoparticle Technology

 
• By 

In Vivo sits down with Ying Tam, CSO at Acuitas Therapeutics, to discuss the company's role in delivering the first personalized CRISPR treatment to an infant and the clinical implications of new lipid nanoparticle technologies.

MitoRx’s Muscle-Preserving Obesity Drug Takes Aim At GLP-1 Limitations

 
• By 

UK biotech targets the root cause of metabolic disease while preserving muscle mass in a crowded obesity market.

Behind The Buyout: Dispatches From The Dealmaking Table

 
• By 

In a challenging funding environment for biopharma, strategic dealmaking has become a critical growth engine. In Vivo explores what it truly takes to navigate high-stakes acquisitions and partnerships, drawing on insights from seasoned industry leaders.

More from Leadership

Kris Joshi Named Norstella CEO, Prioritizes AI Innovation

 
• By 

Joshi joins the parent company of Citeline, which houses flagship publications In Vivo, Scrip and Pink Sheet, to focus on AI, business harmonization and long-term growth.

Rising Leaders 2025: Regeneron’s Karen Rodriguez Lorenc On Not Believing In Failure

 
• By 

Karen Rodriguez Lorenc has overseen linvoseltamab's development and subsequent approvals in Europe and the US. She talked to In Vivo about how patient-centric drug development philosophy is core to her leadership, and why she doesn't believe in failure.

Podcast: Acuitas CSO On CRISPR Delivery Breakthrough And Next-Gen Lipid Nanoparticle Technology

 
• By 

In Vivo sits down with Ying Tam, CSO at Acuitas Therapeutics, to discuss the company's role in delivering the first personalized CRISPR treatment to an infant and the clinical implications of new lipid nanoparticle technologies.