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    DRUG:

    maveropepimut-S (MVP-S)

    i
    Other names: EMD 640 744, EMD-640744, EMD 640744, MVP-S, DPX-Survivac, EMD640744
    Company:
    BioVaxys, EMD Serono
    Drug class:
    Survivin inhibitor
    Related drugs:
    3ms
    PESCO: Phase 2 Study of Pembrolizumab, DPX-Survivac Vaccine and Cyclophosphamide in Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer (clinicaltrials.gov)
    P2, N=47, Active, not recruiting, University Health Network, Toronto | Trial completion date: Feb 2025 --> Apr 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • cyclophosphamide • maveropepimut-S (MVP-S)
    10ms
    Characteristics of relapsed/refractory diffuse large B-cell lymphoma patients with durable responses to maveropepimut-S, pembrolizumab, and cyclophosphamide: Long-term follow-up from the SPiReL trial. (PubMed, EJHaem)
    The regimen was well-tolerated with minimal Grade 3-4 toxicities. Combination immunotherapy regimens such as this could offer a promising alternative to other treatments with significant toxicities for select patients.
    Journal
    |
    BIRC5 (Baculoviral IAP repeat containing 5)
    |
    Keytruda (pembrolizumab) • cyclophosphamide • maveropepimut-S (MVP-S)
    1year
    Intensity of survivin expression linked to features of aggressive relapsed/refractory diffuse large B-cell lymphoma. (PubMed, Leuk Lymphoma)
    SPiReL is a phase II clinical trial evaluating combination immunotherapy, pembrolizumab and cyclophosphamide, with maveropepimut-S, in survivin-expressing relapsed/refractory (R/R) Diffuse Large B Cell Lymphoma (DLBCL). High intensity survivin expression is associated with aggressive clinical features supporting a pathobiological role in R/R DLBCL. Future prognostic models incorporating survivin as a clinical biomarker require assessment of intensity, overall expression and should include potential threshold effects of survivin in DLBCL pathobiology.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    BIRC5 (Baculoviral IAP repeat containing 5)
    |
    BIRC5 expression
    |
    Keytruda (pembrolizumab) • cyclophosphamide • maveropepimut-S (MVP-S)
    almost2years
    Neoadjuvant DPX-Survivac Aromatase Inhibition, Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, Providence Health & Services | Trial primary completion date: Nov 2023 --> Jun 2023
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HER-2 expression • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    cyclophosphamide • letrozole • maveropepimut-S (MVP-S)
    almost2years
    PESCO: Phase 2 Study of Pembrolizumab, DPX-Survivac Vaccine and Cyclophosphamide in Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer (clinicaltrials.gov)
    P2, N=47, Active, not recruiting, University Health Network, Toronto | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • cyclophosphamide • maveropepimut-S (MVP-S)
    2years
    Intensity of Survivin Expression Correlates with Clinical and Biological Markers of Aggressive R/R DLBCL (ASH 2023)
    Introduction: The SPiReL phase II clinical trial evaluated combination immunotherapy with an immunogenic vaccine formulation to the tumor antigen survivin comprised of maveropepimut-S (MVP-S), pembrolizumab and cyclophosphamide in survivin-expressing relapsed or refractory (R/R) diffuse large B cell lymphoma (DLBCL). The mean and median percentage of survivin-positive tumor cells for all enrolled participants (n= 25) was 91% and 99%, respectively. At the per participant level, the range of survivin expression was 50-100% of the cellular content. The heterogeneity of survivin expression intensity among participants is shown in Figure 1.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    BIRC5 (Baculoviral IAP repeat containing 5) • MVP (Major Vault Protein)
    |
    BIRC5 expression
    |
    Keytruda (pembrolizumab) • cyclophosphamide • maveropepimut-S (MVP-S)
    over2years
    Neoadjuvant DPX-Survivac Aromatase Inhibition, Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, Providence Health & Services | Recruiting --> Active, not recruiting | N=18 --> 6 | Trial completion date: Jun 2026 --> Sep 2026 | Trial primary completion date: Jun 2023 --> Sep 2023
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • HER-2 expression • HR positive + HER-2 negative
    |
    cyclophosphamide • letrozole • maveropepimut-S (MVP-S)
    over2years
    SPiReL: DPX-Survivac and Checkpoint Inhibitor in DLBCL (clinicaltrials.gov)
    P2, N=25, Completed, Sunnybrook Health Sciences Centre | Active, not recruiting --> Completed
    Trial completion • Checkpoint inhibition
    |
    BIRC5 (Baculoviral IAP repeat containing 5)
    |
    BIRC5 expression
    |
    Keytruda (pembrolizumab) • cyclophosphamide • maveropepimut-S (MVP-S)
    over2years
    PD-L1 expression predicts efficacy in the phase II SPiReL trial with MVP-S, pembrolizumab, and low-dose CPA in R/R DLBCL. (PubMed, Eur J Haematol)
    This immunotherapy combination was found to be active and safe in this clinically challenging patient population.
    P2 data • Clinical Trial,Phase II • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD20 (Membrane Spanning 4-Domains A1) • BIRC5 (Baculoviral IAP repeat containing 5) • MVP (Major Vault Protein)
    |
    PD-L1 expression • CD20 positive
    |
    Keytruda (pembrolizumab) • cyclophosphamide • maveropepimut-S (MVP-S)
    over2years
    PESCO: Phase 2 Study of Pembrolizumab, DPX-Survivac Vaccine and Cyclophosphamide in Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer (clinicaltrials.gov)
    P2, N=47, Active, not recruiting, University Health Network, Toronto | Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2023 --> Dec 2023
    Enrollment closed • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • cyclophosphamide • maveropepimut-S (MVP-S)
    over2years
    Maveropepimut-S, a DPX-based immune-educating therapy, shows promising and durable clinical benefit in patients with recurrent ovarian cancer, a phase 2 trial. (PubMed, Clin Cancer Res)
    MVP-S with intermittent low-dose CPA is well-tolerated, with clinical benefit for patients with recurrent OvCa. Observed responses are irrespective of the platinum status.
    P2 data • Journal
    |
    BIRC5 (Baculoviral IAP repeat containing 5)
    |
    cyclophosphamide • maveropepimut-S (MVP-S)
    over2years
    An immune-educating therapy, Maveropepimut-S, elicits a diverse and active anti-tumor T cell response in patients with advanced recurrent ovarian cancer (AACR 2023)
    These data indicate that treatment of advanced recurrent ovarian cancer patients with MVP-S based therapy induced robust, persistent survivin-specific T cells that were detected in circulation up to 420 days. These de novo elicited T cells were demonstrated to migrate into tumor tissues, where MVP-S therapy promoted reinvigoration of the total T cell population with new highly diverse clones including strong expansion of survivin-specific T cells.
    Clinical • Metastases
    |
    BIRC5 (Baculoviral IAP repeat containing 5) • TRB (T Cell Receptor Beta Locus)
    |
    maveropepimut-S (MVP-S)