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    DRUG CLASS:

    ICAM-1-targeted CAR-T immunotherapy

    Related drugs:
    4ms
    Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer (clinicaltrials.gov)
    P1, N=70, Recruiting, AffyImmune Therapeutics, Inc. | N=30 --> 70 | Trial completion date: Dec 2024 --> Aug 2030 | Trial primary completion date: Jun 2024 --> Aug 2026
    Enrollment change • Trial completion date • Trial primary completion date • CAR T-Cell Therapy • Metastases
    |
    BRAF (B-raf proto-oncogene) • ICAM1 (Intercellular adhesion molecule 1)
    |
    AIC100
    11ms
    Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer (clinicaltrials.gov)
    P1, N=30, Recruiting, AffyImmune Therapeutics, Inc.
    Trial completion date • CAR T-Cell Therapy • Metastases
    |
    BRAF (B-raf proto-oncogene) • ICAM1 (Intercellular adhesion molecule 1)
    |
    BRAF mutation • BRAF wild-type
    |
    AIC100
    1year
    Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer (clinicaltrials.gov)
    P1, N=30, Recruiting, AffyImmune Therapeutics, Inc. | Trial primary completion date: Sep 2023 --> Jun 2024
    Trial primary completion date • CAR T-Cell Therapy • Metastases
    |
    BRAF (B-raf proto-oncogene) • ICAM1 (Intercellular adhesion molecule 1)
    |
    BRAF mutation • BRAF wild-type
    |
    AIC100
    over1year
    Safety and early efficacy results of phase 1 study of affinity tuned and trackable AIC100 CAR T cells in ICAM-1 positive relapsed and/or refractory advanced poorly differentiated and anaplastic thyroid cancers. (ASCO 2023)
    AIC100 is received as a single infusion two days after completing lymphodepletion with Fludarabine/Cyclophosphamide. AIC100 demonstrated an excellent safety profile in DL1/DL2 treated patients with ATC and PDTC with no DLTs observed. The objective and relatively durable partial response in the first evaluable patient in the DL2, a patient with metastatic ATC who failed multiple lines of therapy, is unprecedented and very encouraging. Further investigations of AIC100 are ongoing at DL2 and DL3 to determine the RP2D.
    Clinical • P1 data • CAR T-Cell Therapy • Metastases
    |
    SSTR (Somatostatin Receptor) • ICAM1 (Intercellular adhesion molecule 1) • SSTR2 (Somatostatin Receptor 2)
    |
    SSTR2 expression • SSTR Expression
    |
    cyclophosphamide • fludarabine IV • AIC100
    almost2years
    Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer (clinicaltrials.gov)
    P1, N=24, Recruiting, AffyImmune Therapeutics, Inc. | Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: Jul 2023 --> Dec 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene) • ICAM1 (Intercellular adhesion molecule 1)
    |
    BRAF mutation • BRAF wild-type
    |
    AIC100
    over2years
    First-in-human study of ICAM-1-specific affinity tuned CAR T cells against advanced thyroid cancer (AACR 2022)
    The CAR T cells are engineered to co-express somatostatin receptor 2 (SSTR2), which allows for the tracking of CAR T cells in vivo via PET/CT scan using FDA-approved DOTATATE. AIC100 was generated by affinity tuning the I-domain of LFA-1, the physiological ligand to ICAM-1... We have developed affinity tuned CAR T cells designed to selectively target ICAM-1 overexpressing tumor cells and to spatiotemporally image CAR T cells. Near-synchronous FDG and DOTATATE scans will enhance patient safety by early detection of off-tumor CAR T activity and validation of tumor response. We anticipate that our “tune and track” technology will be widely applicable to developing potent yet safe CAR T cells against hard-to-treat solid cancers.
    P1 data • CAR T-Cell Therapy
    |
    SSTR (Somatostatin Receptor) • ICAM1 (Intercellular adhesion molecule 1) • SSTR2 (Somatostatin Receptor 2)
    |
    ICAM1 overexpression • SSTR2 expression • SSTR Expression
    |
    AIC100
    over2years
    Focused IL-12 cytokine delivery enhances function of affinity-tuned and real-time tracked ICAM-1-specific CAR T cells in solid tumors (AACR 2022)
    AIC1010 CAR T cells demonstrate superior cancer elimination compared to AIC100 CAR T cells in subcutaneous and IP tumor models in mice. We anticipate that cytokine delivery, paired with our “Tune & Track” technology will be widely adaptable to develop potent and safe affinity-tuned CAR T cells against hard-to-treat solid cancers.
    CAR T-Cell Therapy
    |
    SSTR (Somatostatin Receptor) • ICAM1 (Intercellular adhesion molecule 1) • SSTR2 (Somatostatin Receptor 2) • NFATC1 (Nuclear Factor Of Activated T Cells 1)
    |
    ICAM1 overexpression • SSTR2 expression • SSTR Expression
    |
    AIC100
    4years
    Study of AIC100 in Relapsed/Refractory Thyroid Cancer (clinicaltrials.gov)
    P1, N=24, Recruiting, AffyImmune Therapeutics, Inc. | Not yet recruiting --> Recruiting | Initiation date: Jun 2020 --> Sep 2020
    Clinical • Enrollment open • Trial initiation date
    |
    BRAF (B-raf proto-oncogene) • ICAM1 (Intercellular adhesion molecule 1)
    |
    BRAF mutation
    |
    AIC100
    over4years
    Study of AIC100 in Relapsed/Refractory Thyroid Cancer (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Weill Medical College of Cornell University
    Clinical • New P1 trial
    |
    BRAF (B-raf proto-oncogene) • ICAM1 (Intercellular adhesion molecule 1)
    |
    BRAF mutation
    |
    AIC100