On January 11, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that the company entered into an agreement with the National Cancer Institution (NCI), an institute of the National Institutes of Health (NIH), for worldwide exclusive commercial rights to the NIH’s CD22 chimeric antigen receptor (CAR) with a fully-human binder for use in certain in vivo gene therapy and ex vivo allogeneic CAR T applications for B cell malignancies (Press release, Sana Biotechnology, JAN 11, 2022, View Source [SID1234598584]).
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Engineered CAR T cell therapies for B cell malignancies use binders to target proteins expressed on the surface of B cells. One such protein, CD19, has been the target of all approved autologous CAR T therapies for B cell lymphoma and B cell acute lymphoblastic leukemia to date. Unfortunately, incomplete responses or relapses occur in over 50% of CD19 CAR T-treated patients, often due to CD19 antigen loss. CD22, which is also a B cell surface protein, has emerged as an alternative to address failure to achieve durable complete responses with CD19-directed CAR T therapy. Multiple academic clinical trials using this CD22 CAR have shown complete responses in a substantial number of patients in the relapse setting after treatment with a CD19-directed CAR T therapy for patients with B malignancies.
"We are thrilled to enter an agreement with the NIH for an exclusive license to this fully-human CD22 CAR, particularly given the clinical data with this specific construct to date. One of Sana’s primary goals has been to meaningfully expand the number of patients that benefit from CAR T therapies, with an initial focus on B cell malignancies, including leukemia and lymphoma," said Terry Fry, M.D., Sana’s Head of T Cell Therapeutics. "Combining this CD22 CAR with Sana’s platforms gives us the potential to improve the overall rate of durable complete responses for patients with B cell malignancies – including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia – and expand the number of patients who can receive these therapies."
Under the terms of the agreement, Sana agreed to pay the NIH an upfront amount, certain milestone payments, and royalties on net sales of royalty-bearing products.