maveropepimut-S (MVP-S)

We studied MRI immune cell tracking in a murine model of ovarian cancer using a clinically relevant treatment combination of DPX-Survivac, anti-PD-1, and an intermittent low dose of Cyclophosphamide (CPA). The density of SPIO-labeled myeloid and CD8+ T cells in tumors was higher in the treatment group than in the control group. This study provides insights into how MRI can be used in concert with biological assays to study how immunotherapy and chemotherapy combinations exert their antitumor effects.

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

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.

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.

P1, N=6, Active, not recruiting, Providence Health & Services | Trial primary completion date: Nov 2023 --> Jun 2023

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

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.

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

P2, N=25, Completed, Sunnybrook Health Sciences Centre | Active, not recruiting --> Completed

This immunotherapy combination was found to be active and safe in this clinically challenging patient population.

P2, N=47, Active, not recruiting, University Health Network, Toronto | Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2023 --> Dec 2023

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.