Highlights from our July 2024 Bridging the Gap webinar
Imagine harnessing your body’s own immune cells to fight and destroy cancer—a reality that Tumor-Infiltrating Lymphocytes (TIL) therapy is making possible. TIL therapy was the key topic of our July “Bridging the Gap” webinar with guest speaker Raj Puri, M.D., Ph.D.
Dr. Puri, an Executive Vice President at Iovance Biotherapeutics, brings a wealth of experience from his 33 years at the FDA, including his role as Director of the Division of Cellular and Gene Therapies. The session was moderated by Dr. Patrick Hainley from Children’s National Hospital and featured contributions from permanent panelist Albert Ribickas of Moffitt Cancer Center, co-hosts Olga Bukatova from Azenta Life Sciences, and Tom Whitehead from the Emily Whitehead Foundation, along with patient advocate Chris White.
The Promise of TIL Therapy
Tumor-Infiltrating Lymphocytes (TIL) therapy represents a significant breakthrough in the treatment of solid tumors. This innovative approach harnesses the body’s own immune cells to attack cancer. TIL therapy involves extracting T-cells from a patient’s tumor, expanding them to billions in a lab, and re-infusing them into the patient to target and destroy cancer cells.
Dr. Puri shared his journey from working on adoptive immunotherapy approaches in Dr. Steven Rosenberg’s laboratory at the National Cancer Institute (NCI) to his current role at Iovance Biotherapeutics. Reflecting on the progress, he remarked, “I never imagined I would become the director of the Division of Cell and Gene Therapy at the FDA, a specialized and unique division. It has been uniquely challenging to evaluate this rapidly evolving field and develop the necessary policies and guidance documents.” His contributions have been pivotal in shaping the regulatory framework for advanced therapies.
Patient Advocacy and Real-World Impact
Chris White, a mucosal melanoma survivor, shared his powerful story of how TIL therapy saved his life. Diagnosed with a rare and aggressive form of melanoma, Chris underwent multiple treatments before being introduced to TIL therapy at MD Anderson. His journey included numerous surgeries, chemotherapy, radiation, and immunotherapy.
“By that nine-month mark, they were telling me I had a CMR or a complete metabolic response. And so followed up with a couple of PET scans, and I’ve been scanning clean and clear ever since,” Chris revealed.
The emotional impact of such stories underscores the importance of continued research and development in this field. Tom Whitehead, co-host and co-founder of the Emily Whitehead Foundation, emphasized the significance of these therapies, sharing his own family’s experience and their ongoing commitment to supporting other patients.
Challenges and Future Directions
Dr. Puri outlined the extensive process involved in developing and manufacturing TIL therapy. He highlighted the collaborative approach between Iovance Biotherapeutics and treatment centers like Moffitt Cancer Center, emphasizing the importance of mastering centralized manufacturing and logistics to ensure timely and effective delivery of TIL products.
He also touched on the complexities of scaling up production to meet global demand, noting, “Our Iovance team goes in and trains the staff at advanced treatment centers, ensuring a seamless collaboration. This comprehensive process includes in-person training, instructional videos, and detailed logistics. We cover every aspect from shipping and packing to storing and handling the product, ensuring all procedures are clearly defined and followed.”
Expanding Indications and Future Approvals
The webinar also provided insights into the future directions of TIL therapy. Dr. Puri discussed ongoing and upcoming clinical trials aimed at expanding the indications for TIL therapy beyond melanoma. “We currently have a TILVANCE-301 study, a Phase III clinical trial to support the accelerated approval of lifileucel in the US in combination with Pembrolizumab in frontline advanced melanoma as well as the regular approval of AMTAGVI, anti-PT-1 melanoma,” he shared. Additionally, trials for non-small cell lung cancer, endometrial cancer, and next-generation TIL therapies are underway, promising broader applications and improved outcomes.
Key Takeaways
- TIL Therapy Mechanism: Tumor-Infiltrating Lymphocytes (TIL) therapy involves extracting, expanding, and re-infusing T-cells to target cancer cells.
- Regulatory Framework: Dr. Raj Puri’s contributions to FDA policies have been crucial in the development and approval of advanced therapies.
- Patient Success Stories: Real-world impacts, like Chris White’s survival, highlight the effectiveness and potential of TIL therapy.
- Manufacturing Challenges: Ensuring consistent, high-quality production and distribution of TIL products requires extensive collaboration and innovation.
Conclusion
The July edition of the Bridging the Gap webinar series provided a comprehensive overview of the advancements in TIL therapy and its potential to revolutionize cancer treatment. With leaders like Dr. Raj Puri and dedicated patient advocates like Chris White, the future of advanced therapies looks promising. Stay tuned for more updates and insights from our upcoming sessions.
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About the Guest
Dr. Puri
Raj Puri, M.D., Ph.D. joined Iovance Biotherapeutics in March 2022, bringing decades of experience in evaluating and regulating advanced therapies such as cell and gene therapy, cancer vaccines, and cellular immunotherapy. He spent 33 years at the FDA, including over 19 years as Director of the Division of Cellular and Gene Therapies in the office of Tissue and Advanced Therapies in Center for Biologics Evaluation and Research (CBER), FDA. He also participated in and supervised development of FDA policies and guidance documents for advanced therapies.
Dr. Puri has published over 300 articles, participated in 220+ speaking engagements, and holds numerous patents, many of which are licensed for further development. Dr. Puri has received several prestigious awards, including the FDA Award of Merit, FDA CBER’s Scientific Achievement Award, FDA Commissioner’s Special Citations and the SITC Collaborator Award. He trained at the Surgery Branch of the National Cancer Institute (NCI), where he worked in the laboratory of Dr. Steven Rosenberg on adoptive immunotherapy approaches including Tumor Infiltrating Lymphocytes (TIL) therapy for cancer.
Dr. Puri was trained at the Mayo Clinic, Rochester, MN and holds an M.D. from the University of Juarez Medical School and a Ph.D. from the Central Drug Research Institute in India.