Aleta Biotherapeutics is pioneering transformation of cancer treatment by enabling CAR T cancer therapies to work more effectively. The Company’s portfolio of multi-antigen CAR T Engagers (CTEs) are simple, biologics designed to enhance the expression of CAR T target antigen in any tumor cell.
Our CTEs bind to cancer cells to enhance the efficacy of CAR T cell therapies. Aleta CTEs work by increasing cancer target density, preventing resistance and escape from therapy, and increasing the speed and effectiveness with which CAR T cells can kill cancer cells.
Clinical Program: Aleta-001
Our clinical stage program, ALETA 001, has won landmark support and funding from Cancer Research UK for Phase I/II clinical trials and received an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).
ALETA-001 is being developed to treat B cell lymphoma and leukemia patients experiencing relapse following treatment with anti-CD19 CAR T cell therapy, a high unmet need patient population. Phase I/II clinical trials began in February 2024.
(For more information on this trial please visit clinicaltrials.gov (NCT06045910))
In addition, ALETA-001 is planned for PhaseI/II clinical trials in adjunct setting (early dosing after CART therapy.)
ALETA-001: Simple Biologic, GMP, Vialed and Released
Pipeline
Programs
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ALETA-001 is in Phase I/II Clinical Trials. A CTE that contains the CD19 target protein that is recognized by the approved anti-CD19 CAR T cell therapeutics, which is further linked to an anti-CD20 antibody domain. ALETA-001 is designed to improve the effectiveness of anti-CD19 CAR T therapies by increasing CD19 antigen density and restoring lost CD19 expression. This allows CD19+/CD20+ cancer cells to be easily recognized and killed by anti-CD19 CAR T-cells that were prior administered and are already circulating within a patient. ALETA-001 binds with high affinity to the CD20 cancer antigen to display CD19 protein, which in turn attracts circulating CD19 CAR T cells. ALETA-001 increases CD19 antigen density and prevents cancer escape that commonly occurs due to loss of cancer cell CD19 expression. Therefore, the anti-CD19 CAR T cells have the heightened potential to become more activated and to kill cancer cells more easily (Read Here).
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ALETA-004 is a preclinical, multi-antigen binding CTE designed to extend the cancer killing activity of CD19 CAR T cells to treat patients with advanced acute myeloid leukemia (AML), a deadly blood cancer. ALETA-004 binds two well- known AML antigens, and links them to CD19 CAR T cells using the same CD19 target protein that is recognized by the approved anti-CD19 CAR T cell therapeutics. The ALETA-004 CTE is the culmination of scientific advances first published by Aleta in 2022 (Rennert et al link).
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ALETA-005 is a discovery stage CTE that contains the same BCMA target protein that is recognized by the approved CAR T cell therapeutics and is linked to multiple myeloma antigen-binding domains. ALETA-005 is designed to be given alongside BCMA CAR T therapy for the treatment of advanced multiple myeloma patients, and functions by presenting multiple binding sites for the BCMA CAR T cells and optimally stimulating their ability to kill the multiple myeloma cancer cells. Aleta recently presented data from the ALETA-005 program (SITC 2022 link).
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ALETA-002 and ALETA-003 are designed to treat solid tumor cancers. They use CD19-protein based CTEs directed to well-validated the solid cancer cell antigens. Each is designed to be incorporated into a CD19 based CAR T therapy, to connect non-B cell cancers to CD19 CAR T cells to enable cancer cell killing. This strategy evokes fundamental immunology – the interaction of T cells with CD19-expressing B cells – to drive increased CAR T cell expansion and persistence (Ambrose et al).
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