Immunovaccine Inc. today announced that it will focus the Phase I/II clinical development plan for DPX-Survivac on ovarian cancer. The development plan was based on positive input from key opinion leaders in cancer immunotherapy. The Company has also successfully manufactured test batches of DPX-Survivac and established the analytical methods to support the release of a future clinical trial batch.
“We look forward to advancing the clinical development of DPX-Survivac as a potential treatment for ovarian cancer,” said Dr. Randal Chase, President and CEO of Immunovaccine. “This is a silent disease for which so many women are diagnosed once the cancer is in an advanced stage and treatment options are limited.”
About the Development Plan for DPX-Survivac
Initial immunogenicity studies in a mouse model showed that Survivac peptides, formulated in DepoVax(TM), produced more antigen-specific, interferon gamma-producing immune cells, compared to a control formulation previously used in clinical trials. Preliminary safety assessments also indicated that the vaccine administered to mice was well tolerated.
The clinical development plan includes completing more detailed safety and immunogenicity data over the next few months to support a potential future investigational new drug (IND) regulatory filing with the FDA. The clinical plan foresees a seamless transition from the Phase I into the Phase II.
DPX-Survivac uses Survivin-based antigens, in-licensed from Merck KGaA on a worldwide exclusive basis, and formulated in the DepoVax(TM) vaccine delivery platform. Survivin is a major tumor-associated antigen over-expressed in ovarian cancer cells, making it a viable target for immunotherapy. DepoVax will deliver the Survivin-based antigens in a lipid-depot format designed to generate a strong and prolonged immune response.
DPX-Survivac could have broad commercial potential as a therapeutic cancer vaccine because it may potentially be explored in at least nine other solid tumors and hematological cancers. The Company intends to proceed with preclinical testing of DPX-Survivac in a broader range of cancer indications to evaluate additional opportunities.
See full article here