Drug intelligence / Profile preview

ALA-001

Development stage
Discontinued
Lead developer
Alaunos Therapeutics
Modality
TCR-Engineered T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, Gene Therapies
Administration
Intravenous
01

Overview

ALA-001 is an autologous, non-viral T-cell receptor engineered T-cell (TCR-T) therapy developed by Alaunos Therapeutics for the treatment of various solid tumors. The therapy utilizes the proprietary Sleeping Beauty transposon/transposase system, a non-viral gene transfer method, to integrate genes encoding specific TCRs into a patient's own T cells. This approach is designed to target shared tumor-specific "hotspot" mutations in key oncogenic genes, specifically KRAS, TP53, and EGFR, presented by specific Human Leukocyte Antigen (HLA) alleles. ALA-001 employs a library-based strategy where pre-selected TCRs are matched to a patient's specific mutation and HLA profile. The engineered T cells are administered intravenously following lymphodepletion to recognize and eliminate cancer cells expressing the target neoantigens. In August 2023, Alaunos Therapeutics announced a strategic pivot and the termination of the Phase 1/2 trial for ALA-001 to focus on other priorities.

Other names
Neoantigen specific TCR-T cell drug product
02

Targets

p53 R175H/HLA-A*02:01 (Tumor protein p53 R175H mutant peptide-HLA-A*02:01 complex)

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