KEI Comments to the NIH on Exclusive License to UK Firm Poolbeg Pharma

On April 8, 2024, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) regarding the prospective grant of an exclusive license to Poolbeg Pharma Limited, a UK-based company. The license concerns, “Adoptive T Cell Therapy Products Produced Using a Pharmacological p38 Mitogen-Activated Protein Kinase (MAPK) Inhibitor”. The Federal Register notice (89 FR 20486) states that the patents to be licensed pertain to “a method of producing populations of T cells for the treatment of cancer wherein the cells are cultured ( e.g., expanded) in the presence of a p38 mitogen-activated protein kinase (MAPK) inhibitor.”

It goes on to state that,

“In oncology, many investigational adoptive cell therapies rely on antigen-specific T cells isolated from the patient in need of treatment. However, these cells often exist in a terminally differentiated and exhausted state, or enter such a state following manipulation ex vivo, and are unable to mount a robust immune response following reinfusion. Recent evidence suggests that inhibition of P38 MAPK signaling in T cells during ex vivo expansion can ameliorate this performance defect. It is hoped that this modified cell manufacturing approach will enhance treatment efficacy.”

If this technology proves to be effective it may be important that the license includes terms to ensure access.

Additionally, as a foreign-based firm, the Bayh-Dole Act requires that companies “substantially” manufacture in the United States unless a waiver is granted. The Federal Register notice does not mention any information regarding whether a waiver has been sought in this case.

KEI’s full comments on this prospective exclusive license are available here: KEI-Comments-NIH-License-Poolbeg-Pharma-8April2024