T-Cell Therapy Manufacturing Challenges Provide Opportunities for Vendors: Spotlight on IOVANCE (IOVA)

With an upcoming PDUFA date of February 24, 2024, we focus on Iovance (IOVA) in this post.

🧫 Tumor Infiltrating Lymphocytes (TILs) vs. chimeric antigen receptor technology (CAR-T) manufacturing

• Share very similar ex-vivo T-cell manufacturing processes

  • One of the biggest disadvantages of these cell therapies

    • Complex process/logistics

      • See Steps 2-4 (FIG. 1) 📸

    • Drives up costs

    • Sick patients need to wait for weeks to receive therapy

🔬 IOVA is working on streamlining its TIL ex-vivo manufacturing process (FIG. 1) 📸

• Ex-vivo cell expansion (similar to CAR-T)

• Genetic modification is optional for TILs (CAR-T requires genetic modification)

• IOVA Gen2: 22-day manufacturing process

  • Time from T-cell isolation from a patient to infusion back into a patient.

• Upcoming IOVA TIL Gen3: 16-day manufacturing process

🌐 Cell therapy manufacturing challenges, provide opportunities for vendors

• Products and services for ex-vivo T-cell culturing and freezing

  • Media, growth factors, equipment, cell marker assays

• Products and services for improved safety

  • Cell and gene assays to ensure infused cells are safe.

• Software for managing the complex logistics between hospitals and cell therapy providers

  • Product is patient-specific

    • Maintaining the chain of custody during sample processing is critical

      • Sample shipped from procurement site to cell culture manufacturing site then to the infusion site

      • Almost always different facilities across different business entities

        • e.g., IOVA cell therapy center (iCTC) - Philadelphia ^1

      • Sometimes, the manufacturing site is out of the country

        • iCTC will service patients/samples from the U.S. and Europe

FIG. 1. IOVANCE 22-day GMP Mfg. Process. Proprietary Gen 2 technology enhances TIL therapy manufacturing, achieving over 90% success in treating 500+ patients by optimizing production and distribution processes.

Our 16-day, Gen 3 process

In some of our clinical trials, we are also exploring a Gen 3 process which reduces manufacturing to 16 days. The third generation of our process is expected to reduce the wait time between initial tumor sample and infusion for patients.

Footnote:

^1 Cell Therapy Center (iCTC) – Iovance Biotherapeutics (includes video).

📈Enhance your sales and business development strategies with our comprehensive report featuring hundreds of biopharma companies specializing in cell therapy products. Ideal for...

• 🔬 Contract Research Organizations

• 🧪 Contract Manufacturing Organizations

• 🧬 Biopharma vendors looking to expand their horizons

Access our free report here: https://www.biopharmiq.com/cell-therapy-companies-report

Article History:

2/4/2024 - EJV

This article is not investment or legal advice.