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    DRUG:

    Zeltherva (galinpepimut-S)

    i
    Other names: FPI-01, WT-1 analog peptide vaccine, SLS-001, SLS001, WT1 Cancer Vaccine, WT-1 Vaccine, 3D189, 3D-189
    Company:
    3DMed, Ayala Pharma, Memorial Sloan-Kettering Cancer Center, SELLAS Life Sciences
    Drug class:
    Wilms tumor 1 inhibitor
    Related drugs:
    2ms
    REGAL: Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (clinicaltrials.gov)
    P3, N=127, Active, not recruiting, Sellas Life Sciences Group | Trial primary completion date: Sep 2025 --> Dec 2025
    Trial primary completion date
    |
    Venclexta (venetoclax) • cytarabine • azacitidine • decitabine • Zeltherva (galinpepimut-S) • hydroxyurea • Leukine (sargramostim)
    6ms
    Study of 3D189 in Patients With Hematologic Malignancies (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, 3D Medicines | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    WT1 (WT1 Transcription Factor)
    |
    Zeltherva (galinpepimut-S)
    7ms
    REGAL: Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (clinicaltrials.gov)
    P3, N=128, Active, not recruiting, Sellas Life Sciences Group | Trial completion date: Mar 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • cytarabine • azacitidine • decitabine • Zeltherva (galinpepimut-S) • hydroxyurea • Leukine (sargramostim)
    11ms
    Combining a WT1 Vaccine (Galinpepimut-S) With Checkpoint Inhibition (Nivolumab) in Patients With WT1-Expressing Diffuse Pleural Mesothelioma: A Phase 1 Study. (PubMed, JTO Clin Res Rep)
    We enrolled patients with progressive or recurrent DPM treated with at least one course of pemetrexed-based chemotherapy. Median progression-free survival was 3.9 months and the median overall survival was 7.4 months. Coadministration of GPS and nivolumab reported a tolerable toxicity profile and induced immune responses in a subset of patients, but initial response and survival benefit were limited possibly owing to the small sample size.
    P1 data • Journal • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1) • WT1 (WT1 Transcription Factor)
    |
    Opdivo (nivolumab) • pemetrexed • Zeltherva (galinpepimut-S)
    1year
    REGAL: galinpepimut-S vs. best available therapy as maintenance therapy for acute myeloid leukemia in second remission. (PubMed, Future Oncol)
    Clinical trial registration: https://clinicaltrials.gov/study/NCT04229979. The clinical trial identifier is NCT04229979.
    Clinical • Journal
    |
    WT1 (WT1 Transcription Factor)
    |
    Zeltherva (galinpepimut-S)
    1year
    Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers (clinicaltrials.gov)
    P1/2, N=26, Completed, Sellas Life Sciences Group | Active, not recruiting --> Completed | N=90 --> 26
    Trial completion • Enrollment change • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • PGR (Progesterone receptor) • WT1 (WT1 Transcription Factor) • BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    HER-2 negative • KRAS wild-type • RAS wild-type • BRCA mutation • PGR negative
    |
    Keytruda (pembrolizumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
    1year
    Using a Targeted Cancer Vaccine (Galinpepimut-S) with Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov)
    P1, N=10, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Nov 2024 | Trial primary completion date: Jul 2025 --> Nov 2024
    Trial completion • Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    WT1 (WT1 Transcription Factor)
    |
    Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
    1year
    Galinpepimut-S (WT-1 Analog Peptide) Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy (clinicaltrials.gov)
    P2, N=41, Completed, Sellas Life Sciences Group | N=31 --> 41
    Enrollment change
    |
    WT1 (WT1 Transcription Factor)
    |
    Zeltherva (galinpepimut-S)
    1year
    WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation (clinicaltrials.gov)
    P1/2, N=20, Completed, Sellas Life Sciences Group | Unknown status --> Completed | Phase classification: PN/A --> P1/2
    Trial completion • Phase classification
    |
    WT1 (WT1 Transcription Factor) • CD4 (CD4 Molecule)
    |
    WT1 expression • WT1 positive
    |
    lenalidomide • bortezomib • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
    over1year
    Study of 3D189 in Patients With Hematologic Malignancies (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, 3D Medicines | Trial primary completion date: May 2024 --> Dec 2024
    Trial primary completion date
    |
    WT1 (WT1 Transcription Factor)
    |
    Zeltherva (galinpepimut-S)
    over1year
    Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov)
    P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    WT1 (WT1 Transcription Factor)
    |
    Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
    over1year
    SLSG18-301: Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (clinicaltrials.gov)
    P3, N=126, Active, not recruiting, Sellas Life Sciences Group | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Venclexta (venetoclax) • cytarabine • azacitidine • decitabine • Zeltherva (galinpepimut-S) • hydroxyurea • Leukine (sargramostim)