Effecting Synergistic Mechanisms of Action to Attack Hard-to-Treat Cancers
Our lead candidate, DPX-Survivac, is a T cell activating immunotherapy that combines the utility of the novel formulation, with a novel target: survivin.
Survivin, a cancer stem cell antigen and biomarker of cancer progression, is a particularly valuable target because it has the capacity to identify and disrupt cancer biology on multiple levels:
- It is cancer-specific but broadly expressed, currently associated with over 20 types of solid and hematological cancers.
- It is actively implicated in the dysregulation of cell proliferation and cell death.
- It is associated with particularly aggressive tumors and resistant to chemotherapeutic agents.
Survivin isn’t just a tumor-associated-antigen (TAA), it is also an instigator of the disease itself. By infiltrating this target, not only do we efficiently seek out cancer causing cells while leaving healthy tissues unaffected, but we can also disrupt the fundamental processes of cancer cell production and survival.
IMV has an exclusive, worldwide license to survivin from Merck KGaA.
DPX-Survivac in combination with metronomic cyclophosphamide hits the mark on several characteristics of ideal cancer vaccine combination therapies, with the capacity to:
- TARGET a cancer specific marker
- IMPACT tumor progression disabling key tumor survival mechanisms
- Be POTENT enough to address even the hardest-to-treat of cancers
- SUSTAIN exposure to ensure development of immune memory and prolonged tumor death
Multiple Markets & Broad Opportunity
Because we believe that DPX-Survivac has significant market potential across multiple indications, we have pursued a very deliberate, focused clinical strategy where we think it can add the most value. Building on preclinical research that indicated our anti-cancer therapies are able to induce T cell responses, we began pursuing combination therapies for DPX-Survivac where we believe it can most directly benefit underserved patients with hard-to-treat cancers, particularly those who have not responded to next-generation immuno-modulator therapies. Our primary initial indication for DPX-Survivac is in advanced ovarian cancer.
Our current trials include:
- A Phase 1b trial with Incyte evaluating DPX-Survivac in combination with the IDO1 inhibitor epacadostat
- An investigator-sponsored Phase 2 trial with Merck testing DPX-Survivac with the anti-PD-1 antibody, pembroluzimab
Earlier trials in patients with advanced ovarian cancer receiving 3 subcutaneous doses every 3 weeks demonstrated that DPX-Survivac:
- Exhibits a tolerable safety profile, with no treatment-related serious adverse events (SAEs) reported
- Elevates tumor-specific cytotoxic T cells levels as early as 21 days after the first injection
- Induces a cytokine profile associated with a cytotoxic T cell response
- Elevates tumor specific memory T cells after the third vaccination
There are also some early indications that DPX-Survivac can reduce tumor burden in this population.
Additional milestones already achieved by DPX-Survivac include:
- Orphan Drug Designation from European Medicines Agency (EMA) for the treatment of ovarian cancer
- Orphan Drug Designation from the US Food and Drug Administration (FDA) for the treatment of ovarian cancer
- Fast Track Designation from the FDA as a maintenance therapy for patients with advanced ovarian cancer who have no measureable disease following their initial surgery and front-line platinum/taxane chemotherapy