DPX-Survivac uses Survivin-based antigens, in licensed from Merck KGaA, and formulated in the DepoVax™ vaccine delivery platform. Survivin is a major tumor associated antigen over-expressed in at least nine different cancer indications, making it a viable target for immunotherapy. The National Cancer Institute ranks survivin in the top 25 most promising antigens because of its tumor specificity and encouraging track record in clinical trials.
Immunovaccine has FDA clearance to take DPX-Survivac into Phase I/II clinical trials, targeting patients with ovarian cancer.
DPX-Survivac is being tested in Phase I and Phase II clinical trials. The Phase I portion of the clinical trial design is an open label, dose ranging study to identify the optimal dose of DPX-Survivac to use in the Phase II portion of the study treating patients with ovarian cancer. The DPX-Survivac vaccine will be administered after patients have completed debulking surgery and chemotherapy treatments.
Phase I primary endpoint - To assess the safety and tolerability of DPX-Survivac.
Phase I secondary endpoint - To determine levels of cell mediated immunity (CMI) induced in patients by vaccination with DPX-Survivac.
After a successful Phase I clinical trial, Immunovaccine will be permitted to initiate, without any further application to the FDA, a randomized, double-blinded, placebo-controlled Phase II clinical trial to assess the clinical benefit of DPX-Survivac in patients with advanced ovarian cancer.
1. Cancer Specific Expression
Survivin is highly cancer specific. Its expression is virtually undetected in healthy tissue but is over-expressed in multiple cancer types.
Survivin is expressed at high levels in many cancers including: ovarian, prostate, breast, pancreatic, colorectal, multiple myeloma, B-cell lymphoma, glioblastoma, and melanoma.
Immunovaccine chose to formulate DPX-Survivac to target ovarian cancer in initial Phase I / II clinical trials because survivin is expressed in up to 90% of ovarian cancers.
2. Intergral Role in Cancer Cell Survival
Survivin is essential for the survival of cancer cells and is an inhibitor of cell death (known as apoptosis).
