On December 17, 2025, Knowledge Ecology International (KEI) provided comments to the National Institutes for Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: Vaccine Augmented Tumor Infiltrating Lymphocytes for the Treatment of Cancer” (89 FR 95224) to Iovance Biotherapeutics, Inc. (Iovance).
Iovance has entered into previous CRADA and exclusive licensing agreements with the NIH; KEI also commented on their 2021 license for other inventions concerning tumor infiltrating lymphocytes for the treatment of cancers. That license resulted in Amtagvi, an FDA-approved cell therapy for the treatment of advanced melanoma, which was announced at a WAC of $515,000.
KEI’s comments urge the NIH to ensure that this license includes terms that protect patients’ affordable and equitable access to any resultant treatments, including those that address transparency, technology transfer, price gouging, and access in developing countries.
KEI’s full comments are available here: KEI-Comments-NIH-License-Iovance-17Dec2024