(Update: The NIH provided responses to our comments on April 5, 2021 – 86 FR 10092 Response and 86 FR 10081 Response)
On Friday March 5, 2021, Knowledge Ecology International (KEI) submitted comments to the National Institute of Health (NIH) regarding two prospective exclusive licenses to Kyverna Therapeutics (Kyverna), which is located in Berkeley, CA.
The two licenses were for the same technologies, but one license concerned allogeneic T lympocytes (in which the donor and the recipient of the cells are different people) while the other involved autologous T lymphocytes (both the donor and the recipient of the cells are the same individual). The licenses were noticed in the Federal Register as, “Prospective Grant of an Exclusive Patent License: Allogeneic Therapy for the Treatment of Autoimmune Disease Using Chimeric Antigen Receptors Targeting CD19” (86 FR 10092) and the “Prospective Grant of an Exclusive Patent License: Autologous Therapy for the Treatment of Autoimmune Disease Using Chimeric Antigen Receptors Targeting CD19″ (86 FR 10081).
The fields of use for the licenses of both therapies state that they are for “the treatment of autoimmune diseases.”
As the Federal Register notices state, “For many autoimmune diseases there are no FDA-approved therapies, underscoring that there is an unmet need. The development of an autoimmune disease therapeutic targeting CD19 will benefit public health by providing a treatment for patients who may not have any options.”
Considering that, as the NIH says, these patients “may not have any options”, it is imperative that the NIH ensures that these licenses contain terms that guarantee equitable and affordable access to any resultant treatment. The terms included in these exclusive licenses must ensure that desperate patients without alternative treatment options are not held hostage to high prices.
KEI also noted in the comments the potential anticompetitive practices and market consolidation of these licenses. Although this license is to Kyverna, in this treatment area Kyverna has entered into a close partnership with Gilead Sciences. The press notice on the partnership states:
“Kyverna also announced that it has entered into a strategic collaboration and license agreement with Gilead to develop engineered T cell therapies for the treatment of autoimmune disease based on Kyverna’s synthetic Treg platform and synNotch™ technology from Kite, a Gilead Company. Kyverna will be responsible for conducting research activities and initial clinical studies through proof-of-concept and Gilead will be granted an option, upon the exercise of which Gilead will be solely responsible for further clinical development and commercialization efforts for these programs.”
Gilead also has a seat on the Board of Directors of Kyverna. Through this partnership, and Gilead’s acquisition of Kite Pharma (now a wholly-owned subsidiary of Gilead), the company has existing CAR T treatments, including therapies targeting the CD19 cell surface proteins.
The NIH has previously announced exclusive licenses involving CAR technologies and CD19 to Kite/Gilead, and the partnership between Kyverna-Gilead in this area expands upon that. This consolidation may have consequences for access and affordability to any resultant therapy.
The first FDA approved Gilead CD19-targeting therapy, Yescarta (axicabtagene ciloleucel), which was also developed using technology invented by and licensed from the NIH and was the subject of an NIH Cooperative Research and Development Agreement (CRADA), was aggressively priced. Considering Gilead’s partnership with Kyverna in the very area of these technologies, these licenses should be carefully scrutinized for their potential for anticompetitive impact and subsequent pricing abuses resulting from that impact.
KEI’s full comments on the two licenses to Kyverna are available here: KEI-Comments-NIH-License-Kyverna-5March2021