Genesis Biopharma obtained nonexclusive, worldwide rights from the NIH to 43 patents and patent applications relating to adoptive cell therapy using autologous tumor infiltrating lymphocytes (TILs) for the treatment of certain cancers for about $1.2 million. The patent license agreement covers nine issued U.S. patents, 13 U.S. patent applications, and 21 corresponding foreign patents and patent applications.
The company has rights to sublicense the intellectual property. The license agreement will expire on a product-by-product basis upon the expiration of the subject patent rights. Genesis Biopharma agreed to pay expense reimbursements within 60 days of the effectiveness of the deal, royalties, and a percentage of revenues from any sublicensing arrangements. In addition, the company will pay fees on the achievement of certain clinical and regulatory milestones for each indication.
The technologies covered under today’s agreement with the NIH were also the subject of a CRADA with NCI, effective August 5, to develop treatments to destroy metastatic melanoma cells using a patient’s tumor infiltrating lymphocytes.
"We are very pleased to finalize this license agreement as it will now allow us to move forward with the clinical development for Contego™, our ready-to-infuse adoptive cell therapy using TILs, to treat Stage IV metastatic melanoma,” remarks Anthony J. Cataldo, chairman and CEO of Genesis Biopharma.
“We already have a process development and scale-up agreement for the manufacture of Contego with Lonza, one of the world's leading suppliers to the pharmaceutical, healthcare, and life science industries,” he notes.
Contego is made by isolating TILs from an individual patient’s resected tumor, then expanded in vitro to several hundred million cells. The expanded TILs are then infused into the patient, where they subsequently attack melanoma tumors throughout the body. Contego is based on the TIL adoptive cell therapy being used at the NCI, MD Anderson Cancer Center, and the H. Lee Moffitt Cancer & Research Institute.