Immunovaccine Announces Positive Interim Clinical Data from Ovarian Cancer Study of DPX-Survivac in Combination with Epacadostat
HALIFAX, NOVA SCOTIA--(Marketwired - March 29, 2017) - Immunovaccine Inc. ("Immunovaccine" or the "Company") (TSX:IMV) (OTCQX:IMMVF), a clinical stage vaccine and immunotherapy company, today announced the first interim data analysis from its ongoing Phase 1b clinical study of its novel T-cell activating immuno-oncology candidate, DPX-Survivac, in combination with epacadostat and low-dose cyclophosphamide. The analysis included the results of blood tests, tumor biopsies and CT scans to assess safety, disease progression and T-cell response for the first four evaluable patients in the trial.
All patients enrolled in the trial have recurrent ovarian cancer with evidence of progressive disease. Based on the interim analysis, the combination therapy appears to have an acceptable safety profile, with a single grade 3 and single grade 4 event reported and no serious adverse events (SAEs) reported.
At the time of the interim analysis, three of four patients exhibited stable disease, while a fourth patient continued to progress and discontinued the trial. In addition, researchers observed:
- Signs of increased T cell activity in tumors in three of the four patients based on RNA sequencing
- Stable disease with signs of tumor shrinkage in the patient who has been in trial for the longest duration thus far (based on CT scan at day 140)
"We are very encouraged by these early data, which are tremendously important to Immunovaccine, as they help to validate the underlying clinical potential of DPX-Survivac," said Frederic Ors, Immunovaccine's Chief Executive Officer. "Research is consistently demonstrating that activating T cells is a crucial mechanism to improving tumor response ratesi. This desired mechanism of action is exactly what we have developed DPX-Survivac to address, and this data set has provided an encouraging first clinical demonstration of this effect."
Immunovaccine is developing DPX-Survivac as a combination therapy that can significantly expand the range of cancers successfully treatable by novel immunotherapeutic agents. Emerging data from other studies have shown limited clinical efficacy of checkpoint inhibitor monotherapy in ovarian cancer, with response rates ranging from 10-15 percent.ii
Phase 1b Trial and Early Data
The Phase 1b company-sponsored clinical trial is a single-arm, open-label study of patients who have been diagnosed with platinum-resistant and sensitive ovarian cancer, and who have completed first-line treatment with measurable disease. Investigators plan to enroll up to 40 participants at up to ten sites in the U.S. and Canada. The study's primary objective is to assess the safety and immunogenicity of the treatment, and to determine changes in the immune cell infiltration into tumors. Secondary objectives include objective response rate, duration of response, and time to progression.