Chimeric antigen receptor (CAR)-T cell therapy has become a promising immunotherapeutic strategy for the treatment of various blood cancers such as leukemia and lymphoma, but it has shown limited activity against solid cancers. Improving the targeting of solid tumors by CAR-T cells would be a major advance in CAR-T immunotherapy. To accomplish this, FDA inventors have developed chimeric antigen receptors (CARs) specifically targeting cells expressing IL-13Rα2.
IL-13Rα2 is a high affinity receptor for cytokine interleukin-13 (IL-13), is a known tumor antigen, and is a potential target for cancer immunotherapy. The FDA inventors have shown that IL-13Rα2 is overexpressed in a variety of human solid tumors, including malignant gliomas, head and neck cancer, Kaposi’s sarcoma, renal cell carcinoma, ovarian carcinoma, breast cancer, and pancreatic cancer. They used phage display technology to isolate a high affinity single chain fragment variable fragment (scFv) that specifically binds IL-13Rα2. This scFv was cloned into a lentiviral vector fused with CD3ζ domain and co-stimulatory endo-domains of CD28 and 4-1BB. This vector was then used to create therapeutics CAR-T cells that kill IL-13Rα2 positive solid tumors.
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Development Stage: In vivo animal data
Inventors: Raj Puri and Bharatkumar Joshi
Publications: Manuscript in preparation; unpublished as of April 2023
U.S. provisional application 63/169,575 was filed April 1, 2021
PCT application PCT/US2022/023112 was filed April 1, 2022
Product Area: CAR-T, Cellular therapeutics, cancer, biologic, oncology, solid tumors
FDA Reference No: E-2020-020
FDA Technology Transfer Program