maveropepimut-S (MVP-S) / EMD Serono, BioVaxys - LARVOL DELTA

CD90-targeted multiplex virus-like particles (MVPs) for concomitant In Vivo gene editing, transduction, and transcription factor delivery into HSCs (ASH 2025) - "To enrich for gene-modified cells, we evaluatedthe co-delivery of recombinant constitutively active STAT5 in our viral particles (MVP-S), a downstreamtarget triggered by cytokines activating HSCs and a suppressor of p53-mediated DNA damage response.We hypothesized that transient delivery of STAT5 would induce self-renewal of HSPCs, thereby facilitatingpositive enrichment synergizing with negative selection (i.e., chemo selection, CAR-T, ADCs).To confirm functionality of MVP-S, HSPCs from healthy donors in the absence of cytokines were treatedwith MVP-Cas9 (B2M KO + mNeonGreen transgene) or MVP-C+S (B2M KO + mNeonGreen transgene +STAT5)...Furthermore, the in vivo delivery oftranscription factors to a specific population opens new possibilities for in vivo transdifferentiation andprogramming of pathologic subpopulations. MVPs, therefore, have broad utility not only for improvingcurrent gene therapy strategies but can be further utilized in a variety of regenerative..."

IO biomarker • Preclinical • Gene Therapies • Hematological Disorders • B2M • CD34 • MVP • PTPRC • STAT5 • THY1

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 • IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mental Retardation • Non-Hodgkin’s Lymphoma • Oncology • BIRC5 • MVP

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 | Sponsor: University Health Network, Toronto | Trial completion date: Feb 2025 ➔ Apr 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Platinum resistant • Platinum sensitive • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

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) - P2 | "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 • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BIRC5

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."

IO biomarker • Journal • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BIRC5

BioVaxys Acquires Full Portfolio of Former IMV (BioPharm International) - "BioVaxys Technology announced on Feb. 12, 2024 that has acquired the entire portfolio of discovery, preclinical, and clinical development-stage assets from IMV Inc., Immunovaccine Technologies, and IMV USA...As part of the transaction, BioVaxys also acquired the extensive technology portfolio of these assets from HIMV, LLC, an acquisition division formed by Horizon Technology Finance and IMV’s other secured creditors...The transaction is anticipated to close by Feb. 22, 2024...Under the deal, BioVaxys will pay $750,000 upfront in cash...Through the acquisition, BioVaxys gains maveropepimut-S (MVP-S), a DPX-formulated cancer vaccine designed to deliver antigenic peptides from survivin, a cancer antigen commonly overexpressed in advanced cancers."

M&A • Bladder Cancer • Breast Cancer • Diffuse Large B Cell Lymphoma • Genito-urinary Cancer • Gynecologic Cancers • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor

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 | Sponsor: University Health Network, Toronto | Trial completion date: Feb 2024 ➔ Feb 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Neoadjuvant DPX-Survivac Aromatase Inhibition, Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Providence Health & Services | Trial primary completion date: Nov 2023 ➔ Jun 2023

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

AVALON: Maveropepimut-S (MVP-S) and Low-Dose CPA in Patients With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov) - P2b | N=16 | Terminated | Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.) | N=73 ➔ 16 | Trial completion date: Jun 2026 ➔ Aug 2023 | Recruiting ➔ Terminated | Trial primary completion date: Aug 2025 ➔ Jul 2023; Closure of IMV operations

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Oncology • Ovarian Cancer • Solid Tumor

Neoadjuvant DPX-Survivac Aromatase Inhibition, Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: 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 change • Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

SPiReL: DPX-Survivac and Checkpoint Inhibitor in DLBCL (clinicaltrials.gov) - P2 | N=25 | Completed | Sponsor: Sunnybrook Health Sciences Centre | Active, not recruiting ➔ Completed

Trial completion • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BIRC5

Maveropepimut-S, a DPX-Based Immune-Educating Therapy, Shows Promising and Durable Clinical Benefit in Patients with Recurrent Ovarian Cancer, a Phase II Trial (Clin Cancer Res) - P1b/2 | N=85 | DeCidE (NCT02785250) | Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.) | "Twenty-two patients were enrolled. Median age was 58 years (38–78 years). Among the evaluable population, the objective response rate (ORR) was 21% [90% confidence interval (CI), 7.5%–41.9%], with a disease control rate (DCR) of 63% (90% CI, 41.8%–81.3%), including 4 (21%) patients with partial responses, 8 (42%) stable disease, and 7 (37%) progressive disease. The ORRs were consistent across subgroups based on platinum sensitivity, and DCR was higher in the platinum-resistant subpopulation. Four SD patients maintained clinical benefit up to 25 months. Most treatment-related adverse events (TRAE) were grade 1 and 2 (87% of unique events)."

P2 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

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 | Sponsor: University Health Network, Toronto | Recruiting ➔ Active, not recruiting | Trial primary completion date: Feb 2023 ➔ Dec 2023

Enrollment closed • Metastases • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Maveropepimut-S Plus Cyclophosphamide Yields Responses in Recurrent Ovarian Cancer (Cancer Therapy Advisor) - P1/2 | N=85 | NCT02785250 | Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.) | "In the 19 evaluable patients, the objective response rate was 21.1%. All 4 responses were partial responses. Two of the partial responses occurred in patients with platinum-sensitive disease (25.0%) and 2 occurred in patients with platinum-resistant disease (18.2%)....Eight patients had stable disease. The disease control rate was 63.2% overall, 50.0% for patients with platinum-sensitive disease, and 72.7% for patients with platinum-resistant disease....There were no grade 4 or 5 TRAEs, but 36.4% of patients reported grade 3 TRAEs. The most common grade 3 TRAEs were injection site ulcer (n=5), fatigue (n=2), and anemia (n=2)."

P1/2 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Safety, preliminary efficacy and pharmacodynamic (PD) analysis of maveropepimut-S, intermittent low-dose cyclophosphamide and pembrolizumab in patients with advanced, metastatic bladder cancer (AACR 2022) - "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."

Clinical • PK/PD data • Bladder Cancer • Genito-urinary Cancer • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • Urothelial Cancer • BIRC5 • CD4 • CD8 • MVP

Pembrolizumab, maveropepimut-S, and low-dose cyclophosphamide in advanced epithelial ovarian cancer: Results from phase 1 and expansion cohort of PESCO trial. (ASCO 2022) - P2 | "The combination of MVP-S, low-dose CPA, and Pemb was tolerable and met the efficacy endpoint in the expansion cohort in heavily treated PROC. Immuno-genomic correlative analyses are ongoing."

P1 data • Febrile Neutropenia • Nephrology • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor • BIRC5

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."

IO biomarker • Journal • P2 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BIRC5 • CD20 • MVP • PD-L1

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."

Journal • P2 data • Oncology • Ovarian Cancer • Solid Tumor • BIRC5

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) - P1b/2 | "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 • Oncology • Ovarian Cancer • Solid Tumor • BIRC5 • TRB

Maveropepimut-S, an immune-educating therapy with durable clinical benefit in patients with recurrent ovarian cancer (SGO 2023) - No abstract available

Clinical • Oncology • Ovarian Cancer • Solid Tumor

IMV Inc. Announces Strategic Update as well as Fourth Quarter and Full Year 2022 Financial and Operational Results (Businesswire) - "Expected Upcoming Clinical Milestones - Q2 2023: Stage 1 enrollment complete for the Phase 2B VITALIZE r/r DLBCL trial (30 patients); Q3 2023: Stage 1 enrollment complete for the Phase 2B AVALON platinum-resistant ovarian cancer trial (approximately 40 patients); Q3 2023: Preliminary Phase 1 data from the MVP-S and DPX-SurMAGE in non-muscle invasive bladder cancer (NMIBC)."

Enrollment status • P1 data • Bladder Cancer • Diffuse Large B Cell Lymphoma • Genito-urinary Cancer • Gynecologic Cancers • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer

Comprehensive immune profiling of clinical samples from subjects with advanced recurrent epithelial ovarian cancer treated with a novel T cell activating therapy, DPX-Survivac (SITC 2019) - "DeCidE1 trial is assessing the clinical activity of DPX-Survivac in combination with low dose intermittent cyclophosphamide with or without epacadostat in advanced ovarian cancer patients. DPX-Survivac combinational therapy induces robust and sustained survivin-specific responses and promotes T cell infiltration of tumours, without a loss in functionality. The infiltration immune cells beyond T cells has been demonstrated in tumor tissue yet was not consistently detected in PBMCs; a finding that emphasizes the need for immune-profiling of both blood and tumor to gain a full understanding of the mechanism of action of novel immunotherapies and combinations."

Clinical • IO Biomarker • PD(L)-1 Biomarker

AVALON Trial: Phase 2b Study of Maveropepimut-S and Low-Dose Cyclophosphamide in Subjects with Platinum-Resistant, Epithelial Ovarian Cancer (ESMO-GC 2023) - P2b | "Exploratory objectives include characterization of MVP-S induced immune responses in peripheral blood and the tumor microenvironment of paired tissue samples. The study will enroll 73 subjects in North America and Europe."

Clinical • P2b data • Oncology • Ovarian Cancer • Solid Tumor • BIRC5

DPX-Survivac, a novel T-cell immunotherapy, to induce robust T-cell responses in advanced ovarian cancer. (ASCO-SITC 2020) - P1, P1b, P1b/2; "DPX-Survivac stimulates significant clinical anti-tumor responses by inducing strong and sustained survivin-specific T cell responses and increasing infiltration of target-specific T cells into tumors. Clinical trial information: NCT01416038; NCT03332576; NCT02785250. Research Funding: IMV Inc., Pharmaceutical/Biotech Company."

IO Biomarker • BIRC5 • IFNG

DPX-Survivac, a novel T-cell immunotherapy, to induce robust T-cell responses in advanced ovarian cancer. (ASCO-SITC 2020) - P1, P1b, P1b/2; "DPX-Survivac stimulates significant clinical anti-tumor responses by inducing strong and sustained survivin-specific T cell responses and increasing infiltration of target-specific T cells into tumors. Clinical trial information: NCT01416038; NCT03332576; NCT02785250. Research Funding: IMV Inc., Pharmaceutical/Biotech Company."

IO Biomarker • BIRC5 • IFNG