- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), maveropepimut-S (MVP-S) / BioVaxys
Journal, PD(L)-1 Biomarker, IO biomarker: Intensity of survivin expression linked to features of aggressive relapsed/refractory diffuse large B-cell lymphoma. (Pubmed Central) - Jan 3, 2025 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.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), maveropepimut-S (MVP-S) / BioVaxys
Trial completion date, Trial primary completion date, Metastases: PESCO: Phase 2 Study of Pembrolizumab, DPX-Survivac Vaccine and Cyclophosphamide in Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer (clinicaltrials.gov) - Jan 24, 2024 P2, N=47, Active, not recruiting, Trial primary completion date: Nov 2023 --> Jun 2023 Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| maveropepimut-S (MVP-S) / BioVaxys
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: AVALON: Maveropepimut-S (MVP-S) and Low-Dose CPA in Patients With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov) - Sep 13, 2023 P2b, N=16, Terminated, Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Dec 2023 --> Dec 2024 N=73 --> 16 | Trial completion date: Jun 2026 --> Aug 2023 | Recruiting --> Terminated | Trial primary completion date: Aug 2025 --> Jul 2023; Closure of IMV operations
- |||||||||| maveropepimut-S (MVP-S) / BioVaxys
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Neoadjuvant DPX-Survivac Aromatase Inhibition, Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer (clinicaltrials.gov) - Aug 14, 2023 P1, N=6, Active, not recruiting, N=73 --> 16 | Trial completion date: Jun 2026 --> Aug 2023 | Recruiting --> Terminated | Trial primary completion date: Aug 2025 --> Jul 2023; Closure of IMV operations Recruiting --> Active, not recruiting | N=18 --> 6 | Trial completion date: Jun 2026 --> Sep 2026 | Trial primary completion date: Jun 2023 --> Sep 2023
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), maveropepimut-S (MVP-S) / BioVaxys
Trial completion, Checkpoint inhibition: SPiReL: DPX-Survivac and Checkpoint Inhibitor in DLBCL (clinicaltrials.gov) - Jul 27, 2023 P2, N=25, Completed, Recruiting --> Active, not recruiting | N=18 --> 6 | Trial completion date: Jun 2026 --> Sep 2026 | Trial primary completion date: Jun 2023 --> Sep 2023 Active, not recruiting --> Completed
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), maveropepimut-S (MVP-S) / BioVaxys
Enrollment closed, Trial primary completion date, Metastases: PESCO: Phase 2 Study of Pembrolizumab, DPX-Survivac Vaccine and Cyclophosphamide in Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer (clinicaltrials.gov) - Jun 18, 2023 P2, N=47, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2023 --> Dec 2023
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), maveropepimut-S (MVP-S) / IMV Inc
Vitalize Trial: A Phase 2b, Open-Label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of the Novel Immunotherapeutic, Maveropepimut-S, and Pembrolizumab with and without Intermittent Low-Dose Cyclophosphamide, in Subjects with Relapsed/Refractory Diffuse Large B-Cell Lymphoma () - Nov 29, 2022 - Abstract #ASH2022ASH_7450; P2b As of now, 21 sites are actively recruiting in US, Canada, Australia, New-Zealand, and France. Enrollment has begun.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), maveropepimut-S (MVP-S) / BioVaxys
Trial completion date, Checkpoint inhibition: SPiReL: DPX-Survivac and Checkpoint Inhibitor in DLBCL (clinicaltrials.gov) - Nov 10, 2022 P2, N=25, Active, not recruiting, Enrollment has begun. Trial completion date: Oct 2022 --> Oct 2023
- |||||||||| maveropepimut-S (MVP-S) / IMV Inc
DPX-based Immune Education recruits and activates unique subsets of antigen presenting cells to drive immunogenicity of peptide antigens (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_1639; Antigenic peptides formulated in DPX elicit a robust, targeted, and persistent tumor antigen-specific T cell response that for our lead DPX product, Maveropepimut-S, has translated into clinical benefit in multiple cancer indications, including DLBCL and ovarian cancer...Conclusions Collectively these findings highlight quantitative, qualitative, and temporal differences in immune cell recruitment amongst three delivery platforms and show the unique character of the immune response triggered by the DPX platform typified by the recruitment of CD11b + CD11c + APCs that have intrinsically higher capacity for antigen uptake, presentation, and activation. Ethics Approval Experiments were conducted in accordance with ethics protocols approved by the University Committee on Laboratory Animals at Dalhousie University, Halifax, N.S., Canada.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), maveropepimut-S (MVP-S) / IMV Inc
VITALIZE: A phase IIb, open-label, multicenter, randomized parallel-group, two-stage, study of maveropepimut-S, pembrolizumab, with or without intermittent low-dose cyclophosphamide, in r/r DLBCL (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2850; P2b This study will enroll up to 102 eligible subjects at 65 global study sites. Enrollment has begun.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), maveropepimut-S (MVP-S) / IMV Inc
VITALIZE TRIAL: A PHASE 2B, OPEN-LABEL, MULTICENTER, RANDOMIZED PARALLEL-GROUP, TWO-STAGE, STUDY OF MAVEROPEPIMUT-S, PEMBROLIZUMAB, WITH OR WITHOUT INTERMITTENT LOW-DOSE CYCLOPHOSPHAMIDE, IN R/R DLBLC () - May 13, 2022 - Abstract #EHA2022EHA_992; P2, P2b Enrollment has begun, with one subject enrolled as of abstract submission date. Results Trial in progress Conclusion Trial in progress
- |||||||||| maveropepimut-S (MVP-S) / IMV Inc
Proteomic analysis of plasma exosomes as biomarkers of response to MVP-S based immunotherapy (Exhibit Hall; P1040) - Apr 8, 2022 - Abstract #IMMUNOLOGY2022IMMUNOLOGY_1423; P1b/2 Functional annotations of these proteins suggest their role in modulating immune pathways related to Fc receptor mediated signaling and T-cell migration. The results highlight the potential value of plasma exosome assays for monitoring disease and as a potential surrogate response biomarker.
- |||||||||| maveropepimut-S (MVP-S) / BioVaxys
Enrollment closed, Metastases: KEYNOTE 903: Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors (clinicaltrials.gov) - Mar 31, 2022 P2, N=184, Active, not recruiting, The results highlight the potential value of plasma exosome assays for monitoring disease and as a potential surrogate response biomarker. Recruiting --> Active, not recruiting
- |||||||||| maveropepimut-S (MVP-S) / IMV Inc
NK cells are involved in promoting anti-tumor responses to DPX-peptide immunotherapy (Section 39) - Mar 9, 2022 - Abstract #AACR2022AACR_2811; P1b/2 Maveropepimut-S (MVP-S), formerly DPX-Survivac, contains 5 peptides derived from the tumor antigen survivin, as well as poly dIdC and a T helper peptide...In these mice, DPX-R9F immunization was far less effective than in the Rag1-/- mice, showing that only 20% of immunized mice were tumor free and suggesting that DPX-R9F mediated tumor control was partially dependent upon NK cell/ perforin function. Taken together, these results from both clinical/ translational studies and preclinical models suggest a distinct role for NK cells, in addition to the previously recognized role for T and B cells, in DPX-mediated immunotherapeutic efficacy.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), maveropepimut-S (MVP-S) / IMV Inc
Safety, preliminary efficacy and pharmacodynamic (PD) analysis of maveropepimut-S, intermittent low-dose cyclophosphamide and pembrolizumab in patients with advanced, metastatic bladder cancer (La Nouvelle Orleans A-B, Convention Center) - Mar 9, 2022 - Abstract #AACR2022AACR_1733; Taken together, these results from both clinical/ translational studies and preclinical models suggest a distinct role for NK cells, in addition to the previously recognized role for T and B cells, in DPX-mediated immunotherapeutic efficacy. Preliminary data suggest that MVP-S/CPA and pembrolizumab is a well-tolerated combination and shows encouraging preliminary clinical activity in the treatment of advanced or metastatic bladder cancer patients, including patients who have progressed on prior anti-PD-1/L1 therapy.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), maveropepimut-S (MVP-S) / BioVaxys
Trial completion date, Trial primary completion date, Checkpoint inhibition: SPiReL: DPX-Survivac and Checkpoint Inhibitor in DLBCL (clinicaltrials.gov) - Sep 5, 2021 P2, N=25, Active, not recruiting, Conclusions Collectively, these results provide insight for possible response predictors to MVP-S based therapy Trial Registration NCT02785250 Trial completion date: Apr 2022 --> Oct 2022 | Trial primary completion date: Apr 2021 --> Oct 2021
- |||||||||| maveropepimut-S (MVP-S) / BioVaxys
Trial completion date, Trial primary completion date: DeCidE1: Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer (clinicaltrials.gov) - Jun 18, 2021 P1b/2, N=85, Active, not recruiting, N=24 --> 4 | Active, not recruiting --> Terminated; new study Trial completion date: Dec 2020 --> May 2025 | Trial primary completion date: Feb 2020 --> Oct 2020
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), maveropepimut-S (MVP-S) / BioVaxys
Enrollment closed, Checkpoint inhibition: SPiReL: DPX-Survivac and Checkpoint Inhibitor in DLBCL (clinicaltrials.gov) - Feb 15, 2021 P2, N=25, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||||||||| maveropepimut-S (MVP-S) / BioVaxys
Trial completion date, Trial primary completion date, Metastases: KEYNOTE 903: Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors (clinicaltrials.gov) - Jan 5, 2021 P2, N=184, Recruiting, Recruiting --> Active, not recruiting Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), maveropepimut-S (MVP-S) / BioVaxys
Trial completion date, Trial primary completion date, Checkpoint inhibition: SPiReL: DPX-Survivac and Checkpoint Inhibitor in DLBCL (clinicaltrials.gov) - Oct 19, 2020 P2, N=25, Recruiting, Enrollment is continuing to further define the patient population most likely to benefit from this well-tolerated therapy. Trial completion date: May 2021 --> Apr 2022 | Trial primary completion date: May 2020 --> Apr 2021
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