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    DRUG:

    SurVaxM (SVN53-67/M57-KLH peptide vaccine)

    i
    Other names: SVN53-67/M57-KLH peptide vaccine, survivin-targeted peptide vaccine, survivin peptide mimic vaccine
    Company:
    Fosun Pharma, MimiVax
    Drug class:
    Survivin inhibitor
    Related drugs:
    4d
    Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors (clinicaltrials.gov)
    P1, N=14, Recruiting, Roswell Park Cancer Institute | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim) • octreotide acetate
    5ms
    Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Tumors (clinicaltrials.gov)
    P2, N=132, Not yet recruiting, Roswell Park Cancer Institute | Trial completion date: Jan 2028 --> Oct 2028 | Initiation date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jan 2027 --> Oct 2027
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    temozolomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim)
    8ms
    Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Tumors (clinicaltrials.gov)
    P2, N=132, Not yet recruiting, Roswell Park Cancer Institute | Initiation date: Apr 2024 --> Jul 2024
    Trial initiation date • Metastases
    |
    temozolomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim)
    10ms
    NCI-2015-00694: SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov)
    P2, N=66, Active, not recruiting, Roswell Park Cancer Institute | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date
    |
    HLA-A*11 • HLA-A*24
    |
    temozolomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim)
    10ms
    SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE) (clinicaltrials.gov)
    P2, N=247, Active, not recruiting, MimiVax, LLC | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • MGMT (6-O-methylguanine-DNA methyltransferase) • CD8 (cluster of differentiation 8)
    |
    IDH1 mutation
    |
    temozolomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine)
    12ms
    Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Tumors (clinicaltrials.gov)
    P2, N=132, Not yet recruiting, Roswell Park Cancer Institute
    New P2 trial • Metastases
    |
    temozolomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim)
    12ms
    Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors (clinicaltrials.gov)
    P1, N=14, Recruiting, Roswell Park Cancer Institute | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim) • octreotide acetate
    1year
    Targeting survivin for cancer therapy: Strategies, small molecule inhibitors and vaccine based therapeutics in development. (PubMed, Life Sci)
    In addition to small molecules, several survivin peptide vaccines are currently under development...Overall, survivin is a promising cancer drug target. However, challenges still need to be addressed before the survivin targeted therapies can be widely used in the clinics.
    Review • Journal
    |
    BIRC5 (Baculoviral IAP repeat containing 5)
    |
    BIRC5 expression
    |
    SurVaxM (SVN53-67/M57-KLH peptide vaccine)
    1year
    A RANDOMIZED PHASE 2B STUDY OF SURVIVIN VACCINE SURVAXM PLUS ADJUVANT TEMOZOLOMIDE FOR NEWLY-DIAGNOSED GLIOBLASTOMA (SURVIVE) (EANO 2023)
    RESULTS69 patients have been enrolled as of April 11, 2023. CONCLUSIONFindings from this trial will demonstrate the safety and efficacy of survivin vaccine in GBM (Clinical trial information: NCT05163080).
    Clinical • P2b data • IO biomarker
    |
    MGMT (6-O-methylguanine-DNA methyltransferase) • BIRC5 (Baculoviral IAP repeat containing 5)
    |
    BIRC5 expression
    |
    temozolomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine)
    over1year
    SVN53-67/M57-KLH Peptide Vaccine in Treating Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide Maintenance Therapy (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, Roswell Park Cancer Institute | Trial completion date: Nov 2023 --> May 2026 | Trial primary completion date: Apr 2023 --> Sep 2022
    Trial completion date • Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • IFNG (Interferon, gamma)
    |
    HLA-A*02
    |
    lenalidomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim)
    almost2years
    SVN53-67/M57-KLH Peptide Vaccine in Treating Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide Maintenance Therapy (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, Roswell Park Cancer Institute | Trial primary completion date: Jan 2023 --> Apr 2023
    Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • IFNG (Interferon, gamma)
    |
    HLA-A*02
    |
    lenalidomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim)
    almost2years
    Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma. (PubMed, J Clin Oncol)
    SurVaxM appeared to be safe and well tolerated. The combination represents a promising therapy for nGBM. For patients with nGBM treated in this manner, PFS may be an acceptable surrogate for OS. A large randomized clinical trial of SurVaxM for nGBM is in progress.
    Clinical • P2a data • Journal
    |
    CD8 (cluster of differentiation 8) • BIRC5 (Baculoviral IAP repeat containing 5)
    |
    BIRC5 expression • BIRC5 overexpression
    |
    temozolomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim)
    over2years
    SVN53-67/M57-KLH Peptide Vaccine in Treating Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide Maintenance Therapy (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, Roswell Park Cancer Institute | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • IFNG (Interferon, gamma)
    |
    HLA-A*02
    |
    lenalidomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim)
    3years
    SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE) (clinicaltrials.gov)
    P2, N=265, Recruiting, MimiVax, LLC
    New P2 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    IDH1 mutation
    |
    temozolomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine)
    over3years
    Novel therapeutics for patients with well-differentiated gastroenteropancreatic neuroendocrine tumors. (PubMed, Ther Adv Med Oncol)
    Other approaches seeking to build upon the DNA damage created by Lu-Dotatate include combinations of PRRT with radiosensitizers such as heat shock protein 90 inhibitors, hedgehog inhibitors, chemotherapy combinations, and triapine...With regards to novel RTKIs, some of the ones which have demonstrated potent cytoreductive potential include cabozantinib and lenvatinib. Other RTKIs which are further along the clinical development spectrum and have demonstrated benefit in randomized trials include surufatinib and pazopanib. And though single-agent immune checkpoint inhibitors have not demonstrated significant anti-tumor activity in patients with GEP NETs, outside of certain biomarker selected subsets, somatostatin receptor-directed chimeric antigen receptor (CAR) T cells and vaccines such as SurVaxM, which targets survivin, represent two means through which NET-directed immunity may be modulated. The potential of these agents, if clinically realized, will likely improve outcomes for patients with well-differentiated GEP NETs.
    Clinical • Review • Journal • IO biomarker
    |
    BIRC5 (Baculoviral IAP repeat containing 5) • SSTR (Somatostatin Receptor)
    |
    Lenvima (lenvatinib) • pazopanib • Cabometyx (cabozantinib tablet) • Sulanda (surufatinib) • SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Triapine (3-AP)