Immunovaccine Inc. has announced the completion of a detailed analysis of immune responses from patients enrolled in the Phase I clinical trial assessing the safety and tolerability of DPX-0907, a therapeutic cancer vaccine.
The study was designed to evaluate the safety and immunogenicity of DPX-0907 in patients with advanced stage breast, ovarian or prostate cancer.
DPX-0907 combines seven peptide antigens plus an adjuvant with Immunovaccine's DepoVax™ delivery platform. The depot effect created by the DepoVax™ platform is a result of a patented vaccine-in-oil delivery system that presents the antigens and adjuvant to the immune system for a prolonged period of time.
The Phase I trial was conducted at five centers in the U.S. In this open-label, dose-escalating trial, patients received three injections (0.25 mL or 1 mL doses) of the active immune therapy DPX-0907, three weeks apart. Safety was assessed in 11 patients in the 0.25 mL dose group and 11 patients in the 1 mL dose group.
The immunogenicity results were based on an analysis of 9 evaluable patients in the 0.25 mL dose group and 9 evaluable patients in the 1 mL dose group.
The Phase I trial met the primary objective of safety with overall results demonstrating that DPX-0907 is generally well tolerated by all patients and is considered safe at both dose levels. There were no vaccine related serious adverse experiences reported to date.
The secondary objective was to assess whether administration of DPX-0907 could generate an immune response specific to the seven cancer antigens.
Immunovaccine performed a detailed analysis of patients' blood samples that showed cell mediated immunity (CMI) to vaccine targets in all 3 breast cancer patients, 5 of 6 ovarian cancer patients and 3 of 9 prostate cancer patients. Both dose levels produced a targeted immune response in vaccinated patients.
"We have successfully achieved our primary objective, demonstrating the clinical safety of DPX-0907," said Dr. Marc Mansour, Chief Science Officer and Chief Operating Officer. "We saw in most cases that T cells specific to the vaccine targets displayed multiple activation markers following vaccination; these poly-functional T cells are believed to be more effective in targeting cancer cells."
This data confirms the activity of DepoVax™ in humans and its potential to enhance immune responses to peptide vaccines. These Phase I results also provide important data to advance the clinical development of DepoVax™-based vaccines.
Immunovaccine presented this data today at the BioFinance Conference in Toronto, Canada. The Company plans to submit the results from the trial for publication in a peer-reviewed scientific journal.