On March 2, 2026, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: In Vivo Manufactured Anti-CD19 Chimeric Antigen Receptor (CAR) Products for the Treatment or Prevention of B Cell Mediated Autoimmune Diseases” (91 FR 6863) to Kyverna Therapeutics, Inc.
The technology to be licensed involves the development of anti-CD19 targeting CAR-based immunotherapy for autoimmune diseases. As noted in our comments, the NIH has previously licensed this same suite of technologies to Kyverna for other fields of use, and those earlier licenses appear to have been executed while clinical studies were already ongoing.
A primary concern highlighted in KEI’s comments is the potential for market consolidation and anticompetitive practices. Kyverna has entered into a strategic partnership with Gilead Sciences, where Gilead holds a seat on Kyverna’s Board of Directors. Gilead already possesses existing CAR T treatments targeting CD19, and this expanding partnership may have significant consequences for the access and affordability of any resulting therapy.
Furthermore, Kyverna has received three orphan drug designations for CD19-related technologies and reportedly plans to file for FDA approval in the first half of 2026. Given Gilead’s history of high list prices and the substantial government support provided through these licenses and designations, KEI urged the NIH to include safeguards in the agreement to protect affordable and equitable access for patients.
KEI’s full comments are available here: KEI-Comments-NIH-License-Kyverna-2March2026