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

BioVaxys Reports Positive Clinical Study Results from Phase 1B/2 PESCO Trial of MVP-S with Pembrolizumab (Keytruda) and Low-Dose Cyclophosphamide for Patients with Recurrent Epithelial Ovarian Cancer (EOC) (Newsfile) - "Regarding primary study endpoints, the ORR was 24% and the DCR was 82% among patients with high grade endometrial cancer, with median duration of response of 5.5 months among responders. Of note, the benefit was more pronounced in patients with platinum-sensitive disease, who achieved an ORR of 40% and a DCR of 90%. Even among patients with platinum-resistant disease, from the phase 1 dose escalation and cohort B (n=24), outcomes exceeded expectations with an ORR of 16% and a DCR of 54%, compared to standard of care single-agent chemotherapy which typically achieves an ORR around 11.8%."

P1/2 data • Platinum resistant • Platinum sensitive • Endometrial Cancer • Epithelial Ovarian Cancer

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

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

BioVaxys Reports Positive Phase 2 Data for Maveropepimut (MVP-S) + Pembrolizumab and Low-Dose Cyclophosphamide in Metastatic Bladder Cancer (The Newswire) - "Key Findings: Of 17 evaluable subjects, five showed objective responses: 2 confirmed complete responses (CRs) and 3 partial responses (PRs). Notably, three responders—including both confirmed CRs—had previously progressed on prior checkpoint inhibitor therapy, suggesting the combination may overcome resistance in refractory settings. Several patients achieved durable clinical benefit, with one remaining on treatment beyond 18 months. The regimen was well tolerated."

P2 data • Bladder Cancer

A case of recurrent pyoderma gangrenosum injection site reaction triggered by Maveropepimut-S (previously known as DPX-Survivac) in a patient undergoing immunotherapy for ovarian cancer: A case report. (PubMed, SAGE Open Med Case Rep) - "The lesions showed a rapid response to corticosteroid therapy. This case highlights the importance of recognizing pyoderma gangrenosum as a potential cutaneous adverse event in immunotherapy treatments and suggests that timely dermatologic evaluation may help avoid delays in diagnosis and treatment."

Journal • Dermatology • Oncology • Ovarian Cancer • Pyoderma Gangrenosum • Solid Tumor

BioVaxys Announces Phase 1 Clinical Study Results Advancing DPX(TM)-Formulated Products in Patients with Non-Muscle Invasive Bladder Cancer (Newsfile) - "Both MVP-S and DPX-SurMAGE were shown to be well tolerated, with strong antigen-specific T cell responses at Day 0, 28, 49 and 109 determined using INF- γ ELISPOT analyses, a highly sensitive technique to count individual immune cells (typically T cells) that are actively secreting Interferon-gamma (IFN-γ) in response to a specific antigen to reveal the strength of response to a tumor antigen. Of note, 55% of participants receiving MVP-S showed significant responses that peaked at Day 28, and 33% in the DPX-SurMAGE Study Arm showed a significant response that was stronger at Day 49."

P1 data • Bladder Cancer

BioVaxys Announces Positive Phase 1 Clinical Study Results with Maveropepimut-S (MVP-S) in Women with Hormone Receptor Positive/HER2 Negative (HR+/HER2-) Stage II-III Breast Cancer (Newsfile) - "All three patients in the study had at least a 50% decrease in Ki67 between biopsy and surgery, from median 24% (from a range of 12% to 43%) before treatment to median 6% (from a range of 5% to 8%) after treatment. One patient had an 8-fold increase of survivin-specific circulating Interferon-gamma (IFN-γ) T cells at surgery...In women with hormone receptor positive Her2 negative (HR+HER2-) breast cancer, neoadjuvant hormone therapy provides an alternative to chemotherapy with conversion from mastectomy to breast conservation in approximately half of patients2-3. However, one barrier to wide adoption of neoadjuvant hormone therapy is the variability in patient response."

P1 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

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

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