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Publication Number
US-11020466-B2
Publication Date
2021-06-01
Expiration Date
Abstract
The invention provides improved compositions for adoptive T cell therapies for B cell related conditions.
Core Innovation
The invention provides a chimeric antigen receptor (CAR) consisting essentially of the amino acid sequence set forth in SEQ ID NO: 9. The disclosure relates to polynucleotides and vectors that encode the CAR, and describes CAR architectures that include murine anti-BCMA antigen-binding domains, hinge/spacer and transmembrane options, and intracellular co-stimulatory signaling domains and a primary signaling domain including CD3zeta and related ITAM-containing domains.
Immune effector cell embodiments include CAR-expressing T cells and natural killer (NK) cells, including immune effector cells selected from T lymphocytes and NK cells. The document also describes compositions that include the CAR-expressing immune effector cell together with a physiologically acceptable excipient.
Therapeutic use is directed to B cell malignancies, including multiple myeloma and non-Hodgkin lymphoma, using CAR-targeted killing and in vivo persistence. The disclosure also includes PI3K pathway inhibition during T cell activation/expansion, including inhibitors of PI3K/AKT/mTOR, to enrich for developmentally potent CAR T cells and reduce differentiation markers, while mentioning immune biomarker outcomes and cytokine release and cytokine storm risk mitigation alongside robust expansion/persistence and maintained anti-tumor activity.
Claims Coverage
The independent claims are directed to the CAR amino-acid sequence, the polynucleotide encoding that CAR, and a vector comprising the encoding polynucleotide. Across these independent claims, the coverage includes three inventive features: the CAR defined by SEQ ID NO: 9, the encoding polynucleotide, and vectors that include the encoding polynucleotide.
Car consisting essentially of a defined amino acid sequence
A chimeric antigen receptor (CAR) consisting essentially of the amino acid sequence set forth in SEQ ID NO: 9.
Polynucleotide encoding a defined CAR
A polynucleotide encoding a CAR consisting essentially of the amino acid sequence set forth in SEQ ID NO: 9.
Vector comprising a polynucleotide encoding a defined CAR
A vector comprising a polynucleotide encoding a CAR consisting essentially of the amino acid sequence set forth in SEQ ID NO: 9.
Overall, the independent claims cover the defined CAR protein (SEQ ID NO: 9), the nucleic acid that encodes it, and vectors carrying that nucleic acid. The scope is further tied to immune effector cells expressing the CAR and to compositions that include the CAR-expressing immune effector cell with a physiologically acceptable excipient, with additional dependent coverage on vector element details.
Stated Advantages
Reduced cytokine storm risk is mentioned.
Robust expansion/persistence is mentioned.
Maintained anti-tumor activity is mentioned.
Developmentally potent CAR T cells.
Reduced differentiation markers while maintaining relevant marker profiles.
CAR-targeted killing and in vivo persistence.
Therapeutic activity in lymphoma/myeloma models.
Documented Applications
Treating multiple myeloma is disclosed.
Treating non-Hodgkin's lymphoma is disclosed.
Therapeutic use in B cell malignancies, including multiple myeloma and non-Hodgkin lymphoma, using CAR-targeted killing and in vivo persistence.
Use in lymphoma/myeloma models to assess therapeutic activity of anti-BCMA CAR constructs.
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