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    DRUG:

    AST-301

    i
    Other names: AST-301, HER-2/neu ICD Protein, HER-2 ICD Peptide, pNGVL3-hICD, EP 301
    Company:
    Aston Sci., EpiThany, University of Washington
    Drug class:
    HER2 inhibitor
    Related drugs:
    4ms
    Conerstone3: Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer (clinicaltrials.gov)
    P2, N=24, Recruiting, Aston Sci. Inc. | Trial primary completion date: Oct 2023 --> Oct 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    AST-301 • Leukine (sargramostim)
    5ms
    Cornerstone001: Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=10, Terminated, Aston Sci. Inc. | N=146 --> 10 | Trial completion date: Dec 2025 --> May 2024 | Recruiting --> Terminated | Trial primary completion date: Aug 2025 --> May 2024; Difficulty in recruiting patients
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Keytruda (pembrolizumab) • capecitabine • AST-301 • Leukine (sargramostim)
    1year
    AST-301, a pDNA-based cancer vaccine encoding HER2-ICD, enhances anti-tumor effect of HER2-ADC in a HER2-expressed gastric cancer xenograft model (SITC 2023)
    Results It was showed that adding AST-301 to LCB01 or Kadcyla inhibited a tumor growth based on TGI rate at days 25; AST-301 combining with LCB01 vs LCB01 mono (52% vs 43%), AST-301 combining with Kadcyla vs Kadcyla mono (43% vs 34%). Immunologically, the combination of AST-301 and HER2 ADCs suppressed the increase of MDSC in the tumor environment. Based on those supporting data, phase 2 study of AST-301 in HER2-expressed gastric cancer has been active (CornerStone-003, NCT#05771584).
    Preclinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 expression
    |
    Kadcyla (ado-trastuzumab emtansine) • AST-301
    over1year
    Conerstone3: Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer (clinicaltrials.gov)
    P2, N=24, Recruiting, Aston Sci. Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    HER-2 overexpression • HER-2 underexpression
    |
    AST-301 • Leukine (sargramostim)
    over1year
    Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy (clinicaltrials.gov)
    P1/2, N=31, Completed, University of Washington | Unknown status --> Completed
    Trial completion • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • IFNG (Interferon, gamma) • NCAM1 (Neural cell adhesion molecule 1) • LAMP1 (Lysosomal Associated Membrane Protein 1)
    |
    HER-2 overexpression • HER-2 amplification
    |
    Perjeta (pertuzumab) • Trazimera (trastuzumab-qyyp) • AST-301
    over1year
    AST-301, a pDNA-based therapeutic cancer vaccine encoding HER2 ICD, improves the efficacy of checkpoint blockade therapy in CD34+ humanized gastric cancer mouse model (AACR 2023)
    To confirm the tumor suppressive effect of pembrolizumab (anti-PD-1) treatment combined with AST-301 in the hu-CD34+ hematopoietic stem cell-engrafted NSG mice that formed tumors with NCI-N87, AST-301 (100 μg) and pembrolizumab (5 mg/kg) were administered into mice once a week for a total of 3 times and one booster doses of AST-301 was injected at week 4. Currently, we are ongoing study to prove the anti-tumor synergistic effects of the combination of AST-301 and various FDA-approved Antibody Drug Conjugates (ADCs). This effort is focused on narrowing the administration doses to low levels to resolve the safety issue of ADC or ICI, and it will strongly support the diverse applicability of the cancer therapeutic vaccine.
    Preclinical • Checkpoint inhibition • Checkpoint block
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD34 (CD34 molecule)
    |
    Keytruda (pembrolizumab) • AST-301
    over2years
    Cornerstone001: Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=146, Recruiting, Aston Sci. Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • IFNG (Interferon, gamma)
    |
    HER-2 amplification
    |
    Keytruda (pembrolizumab) • capecitabine • AST-301 • Leukine (sargramostim)
    3years
    The anti-tumor activity of HER-2/neu ICD therapeutic cancer vaccine (AST-301, pNGVL3-hICD) in Her2-expressed gastric cancer xenograft model (SITC 2021)
    Treatment groups were assigned as AST-301 alone (AST-301, 0.1 mg/head, i.d.), Trastuzumab (TZM, 20 mg/kg, i.p.) or AST-301 combining with Trastuzumab (AST-301+TZM) respectively. Conclusions Tumor protective and tumor therapeutic effect of AST-301 were demonstrated well in various doses and regimens on HER2/neu positive gastric cancer xenograft model. These data would be supporting a proof of concept (PoC) clinical study of HER-2/neu ICD therapeutic cancer vaccine in certain type of HER2/neu-expressed gastric cancer patient.
    Preclinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Herceptin (trastuzumab) • AST-301
    4years
    Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer (clinicaltrials.gov)
    P1, N=66, Active, not recruiting, University of Washington | Trial completion date: Dec 2023 --> Dec 2024
    Clinical • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    HER-2 overexpression • HER-2 amplification
    |
    AST-301 • Leukine (sargramostim)