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    DRUG:

    A2B530

    i
    Other names: A2B 530, A2B530, Tmod CEA-targeted CAR T , A2B-530
    Company:
    A2 Biotherap
    Drug class:
    CEA-targeted CAR-T immunotherapy
    Related drugs:
    2ms
    EVEREST-1: initial safety data from a seamless phase 1/2 study of A2B530, a logic-gated Tmod CAR T-cell therapy, in patients with solid tumors associated with CEA expression also exhibiting HLA-LOH (SITC 2024)
    β2M shRNA, beta–2–microglobulin short–hairpin RNA; CD, cluster of differentiation; EF1α, elongation factor–1 alpha; LIR, leukocyte immunoglobulin–like receptor; scFv, single–chain variable fragment; T2A, thosea asigna virus 2ADownload figure Open in new tab Download powerpoint Abstract 588 Figure 2 EVEREST-1 study design. BOIN, Bayesian optimal interval design; PCLD, preconditioning lymphodepletion; RP2D, recommended phase 2 dose
    Clinical • P1/2 data • CAR T-Cell Therapy
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    HLA-A (Major Histocompatibility Complex, Class I, A) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CEACAM5 (CEA Cell Adhesion Molecule 5) • B2M (Beta-2-microglobulin) • GZMB (Granzyme B)
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    CEACAM5 expression • HLA-A*02
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    Tempus HLA-LOH assay
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    A2B530
    7ms
    EVEREST-1: A seamless phase 1/2 study of A2B530, a carcinoembryonic antigen (CEA) logic-gated Tmod CAR T-cell therapy, in patients with solid tumors associated with CEA expression also exhibiting human leukocyte antigen (HLA)-A*02 loss of heterozygosity (LOH). (ASCO 2024)
    Sci Transl Med. 2022.
    CAR T-Cell Therapy • P1/2 data • Clinical • IO biomarker
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    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    A2B530
    11ms
    EVEREST-1: A Study to Evaluate the Safety and Efficacy of A2B530, a Logic-gated CAR T, in Subjects With Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression (clinicaltrials.gov)
    P1/2, N=160, Recruiting, A2 Biotherapeutics Inc.
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy • Metastases
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    HLA-A (Major Histocompatibility Complex, Class I, A) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression • HLA-A*02
    |
    A2B530
    1year
    EVEREST-1: A seamless phase 1/2 study of CEA logic-gated Tmod CAR T-cell therapy (A2B530) in patients with solid tumors associated with CEA expression also exhibiting HLA loss of heterozygosity (LOH) (SITC 2023)
    The primary objective of phase 1 is to evaluate the safety and tolerability of A2B530 in patients with NSCLC, CRC, and PANC, and to identify the maximum tolerated dose and recommended phase 2 dose (RP2D). The dose-expansion phase will confirm RP2D and collect biomarker data to further characterize A2B530.
    CAR T-Cell Therapy • P1/2 data • Clinical • IO biomarker
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression • HLA-A*02
    |
    Tempus HLA-LOH assay
    |
    A2B530
    1year
    BASECAMP-1: A master prescreening study to identify patients with high-risk or metastatic solid tumors with HLA loss of heterozygosity (LOH) in preparation for Tmod CAR T-cell therapy trials (SITC 2023)
    BASECAMP-1 is an ongoing prescreening study to: 1) Identify patients with tumor-associated HLA LOH and eligible for Tmod CAR T-cell therapy, and 2) Obtain leukapheresis in preparation for the autologous CAR T-cell therapy trials EVEREST-1 (A2B530 targeting carcinoembryonic antigen; NCT05736731) and EVEREST-2 (A2B694 targeting mesothelin). We have identified 52 patients across sites with study-specific disease types with HLA-A*02:01 LOH; of these, 13 are currently being screened, 23 have been found ineligible, and 16 have consented. This demonstrated the feasibility of leveraging a diagnostic during routine clinical workup to identify rare, molecularly defined patients for personalized clinical studies.
    CAR T-Cell Therapy • Clinical • Metastases
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    HLA-A (Major Histocompatibility Complex, Class I, A) • MSLN (Mesothelin) • CEACAM5 (CEA Cell Adhesion Molecule 5)
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    HLA-A*02
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    Tempus HLA-LOH assay
    |
    A2B530
    over1year
    EVEREST-1: A Study to Evaluate the Safety and Efficacy of A2B530, a Logic-gated CAR T, in Subjects With Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression (clinicaltrials.gov)
    P1/2, N=160, Recruiting, A2 Biotherapeutics Inc. | Not yet recruiting --> Recruiting
    Enrollment open • CAR T-Cell Therapy • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression • HLA-A*02
    |
    A2B530
    almost2years
    EVEREST-1: A Study to Evaluate the Safety and Efficacy of A2B530, a Logic-gated CAR T, in Subjects With Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression (clinicaltrials.gov)
    P1/2, N=160, Not yet recruiting, A2 Biotherapeutics Inc.
    New P1/2 trial • CAR T-Cell Therapy • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    CEACAM5 expression • HLA-A*02
    |
    A2B530
    2years
    A2B530, an autologous CEA-directed Tmod T-cell therapy with an inhibitory receptor gated by HLA-A*02 to target colorectal, pancreatic, and lung cancer (SITC 2022)
    BASECAMP-1 ( NCT04981119 ), an observational study identifying patients with somatic HLA LOH, is recruiting. Eligible patients with metastatic colorectal, pancreatic, or non-small cell lung cancer will be apheresed for a future A2B530 EVEREST-1 interventional study.
    IO biomarker
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    HLA-A (Major Histocompatibility Complex, Class I, A) • CEACAM5 (CEA Cell Adhesion Molecule 5) • LILRB1 (Leukocyte Immunoglobulin Like Receptor B1)
    |
    CEACAM5 expression • HLA-A*02
    |
    A2B530