Lion Biotechnologies, MD Anderson Plan Clinical Trials of TIL Cancer Therapy

Lion Biotechnologies will partner with The University of Texas MD Anderson Cancer Center to carry out multiarm clinical trials assessing the company’s tumor-infiltrating lymphocyte (TIL) therapy in ovarian cancer, various sarcomas, and pancreatic cancer, through a collaboration whose value was not disclosed.

The multiyear strategic alliance will evaluate TIL therapy in multiple solid tumor cancers using two different TIL manufacturing processes. Lion and MD Anderson will both have manufacturing responsibilities for production of TILs used in the planned cellular therapy trials.

“Together, we expect to generate data that will support the pursuit of additional pipeline indications to complement our ongoing Lion-sponsored TIL clinical programs in metastatic melanoma, head and neck, and cervical cancers,” Lion president and CEO Maria Fardis, Ph.D., MBA, said in a statement.

Dr. Fardis said the collaboration is designed to combine Lion's expertise in TIL therapy and expanding TIL manufacturing capacity with MD Anderson's experience in developing novel methods for generating TIL, and in clinical care in treating oncology patients with unmet needs.

The trials will be designed by a joint steering committee of professionals from Lion and MD Anderson, and will be conducted at MD Anderson.

A related preclinical research collaboration will focus on the expansion of TIL from additional rare tumor types, with the goal of identifying new indications for future clinical research.

Lion’s lead product candidate is an adoptive cell therapy that applies TIL toward treating patients with refractory metastatic melanoma.

Lion's technology is based on TILs isolated from the patient's tumor following resection. The cells are expanded to billions in vitro, then infused back into the patient, who has been preconditioned to remove all suppressive influences.

The technology is designed to overcome the immunosuppressive effects of cancer, while leveraging and enhancing the power of TILs to treat, and potentially cure, all solid tumors. In cancer’s early stages, TILs migrate to the tumor and launch an attack—but the effect is usually short-lived because cancer adapts to evade immune detection and suppress immune response.

TIL therapy is also being evaluated in clinical trials at the National Cancer Institute, MD Anderson, and H. Lee Moffitt Cancer & Research Institute, using an adoptive cell therapy regimen developed by NCI chief of surgery Steven A. Rosenberg, M.D., Ph.D.

One Phase II study involving 101 patients with metastatic melanoma conducted by Dr. Rosenberg associated TIL treatment with high, durable, objective response rates, including patients who were refractory to checkpoint inhibitors.

The data showed complete responses in 24% of patients, with 23 of 24 complete responders showing durability of 30 to 47 months. The overall response rate was 56% and overall survival was approximately 80% at 12 months. In addition, the complete response rate was 29% for 34 patients that had failed therapy with checkpoint inhibitors.

Lion’s technologies also include genetically engineered and presorted “next-generation” TILs. Their advantages, the company says, include greater potency and persistence, a shorter manufacturing process with lower cost of goods, fewer cells, stronger intellectual property protection, and cytokine expression that enhances modulation of the immune-suppressing proteins programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).