On June 15, 2020, Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatments (UACT) submitted joint comments to the National Institutes of Health regarding two prospective exclusive patent licenses:
- “Prospective Grant of an Exclusive Patent License: Development and Commercialization of Mono-Specific Chimeric Antigen Receptor (CAR) Therapies for the Treatment of Cluster of Differentiation 33 (CD33) Expressing Malignancies” to Vor Biopharma Inc.
- “Prospective Grant of an Exclusive Patent License: Development and Commercialization of Logic-Gated Chimeric Antigen Receptor (CAR) Therapies for the Treatment of Cluster of Differentiation 33 (CD33) Expressing Cancers” to Senti Bio.
The proposed license was noticed in the Federal Register (85 FR 28966). The technology involved in the licenses concerns a chimeric antigen receptor (CAR) therapy that targets the CD33 surface antigen, which is expressed in acute myelogenous leukemia (AML) and a form of chronic myeloid leukemia (CML). The licenses are for the same technology, but for slightly different treatment indications.
The Vor Biopharma license is for:
“The development of a chimeric antigen receptor (CAR) therapy mono-specific for CD33 for the prophylaxis or treatment of CD33-expressing hematological malignancies wherein the CAR is comprised of the CD33-binding domain referenced as Hu195 or hP67.6, is delivered via lentiviral transduction, and the T cells are:
1. Derived autologously (meaning cells derived from one individual who is both the donor and the recipient) in the first-line or relapsed/refractory setting, or
2. derived allogeneically (meaning cells derived from a matched healthy donor), in the post-transplant setting.”
The Senti Bio license is for:
“1. The development of a CD33-specific logic-gated CAR-based immunotherapy using autologous human T cells transduced with lentiviral vectors, wherein the viral transduction leads to the expression of a CAR that targets CD33 (comprised of the CD33-binding domain referenced as Hu195 or hP67.6 in the invention as well as an intracellular signaling domain), for the prophylaxis or treatment of CD33-expressing cancers. For clarity, “CD33-specific logic-gated CAR-based immunotherapy” means therapies where the CAR-expressing T cells recognize CD33 and are engineered to respond to one or more additional antigens (but not necessarily all of the signals).
2. The development of a CD33-specific logic-gated CAR-based immunotherapy using allogeneic human NK cells transduced with lentiviral vectors, wherein the viral transduction leads to the expression of a CAR that targets CD33 (comprised of the CD33-binding domain referenced as Hu195 or hP67.6 in the invention as well as an intracellular signaling domain), for the prophylaxis or treatment of CD33-expressing cancers. For clarity, “CD33-specific logic-gated CAR-based immunotherapy” means therapies where the CAR-expressing NK cells recognize CD33 and are engineered to respond to one or more additional antigens (but not necessarily all of the signals).”
The invention is being investigated in Clinical Trial No. NCT03971799, which is taking place at the National Institutes of Health (NIH) campus in Bethesda and at Children’s Hospital of Philadelphia. The trial is a Phase 1 and a Phase 2 trial. The fact that this technology is already in testing in human clinical trials greatly reduces the risk to the company when licensing this invention. The NIH should consider these developments when setting the terms of the license, and take this into account before granting a worldwide, life-of-patent, exclusive license to private companies. If it fails to do so then it is not satisfying its obligations under the Bayh-Dole Act.
KEI’s full comments regarding the licenses are available here: Joint_KEI_UACT_NIH_Exclusive_License_Comments_Vor_Biopharma_Senti_Bio_15June2020
(For more KEI comments on NIH licenses, see: https://www.keionline.org/nih-licenses)