IMV inc. today announced that investigators shared new positive data from the company’s ongoing DeCidE1 clinical trial at the 2018 ESMO Immuno-Oncology Congress
DARTMOUTH, Nova Scotia, (GLOBE NEWSWIRE) -- IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, today announced that investigators shared new positive data from the company’s ongoing DeCidE1 (DPX-Survivac with low dose CyclophosphamIDe and Epacadostat) clinical trial at the 2018 ESMO Immuno-Oncology Congress. The phase 1b/2 study is evaluating the safety and efficacy of the combination of IMV’s lead candidate DPX-Survivac, low dose cyclophosphamide, and 100 mg or 300 mg of Incyte’s IDO1 enzyme inhibitor epacadostat in patients with advanced recurrent ovarian cancer.
In a poster presentation, Oliver Dorigo, M.D., Ph.D., Associate Professor of Obstetrics and Gynecology (Oncology), Stanford University Medical Center, who served as the trial’s lead investigator and author on the poster, shared topline safety results from 53 enrolled patients and efficacy data from the 32 participants evaluable for immune-related and clinical responses, as well as blood sample and tumor biopsy analyses.
Key findings include:
- Evidence of a clinical marker based on Baseline Tumor Burden (BTB), a measure of tumor size predictive of patient response to DPX-Survivac.
- 37.5% (12/32) of evaluable study subjects began treatment with a non-bulky disease defined as BTB < 5 cm.
- 73% (8/11) of tumor regressions and 80% of clinical responses (4/5) observed in subset of patients with BTB < 5 cm.
- Responders thus far showing prolonged duration of clinical benefits reaching up to more than two years, surpassing the progression-free interval from their previous chemotherapy treatment.
- Robust systemic survivin-specific T cell responses and evidence of survivin-specific T cells tumor infiltration correlated with clinical benefits.
- 100% of durable clinical responses correlated with T cell infiltration.
- Epacadostat triggered inhibition of the conversion of tryptophan into kynurenine that was dose dependent.
- Cohort demographics were balanced and the combination yielded a tolerable safety profile.
“This data set provided meaningful information on how the potential benefits of DPX-Survivac may best be translated to patients, including the connection between tumor regressions and T cell infiltration in the tumor microenvironment,” said Frederic Ors, Chief Executive Officer at IMV. “We believe that DPX-Survivac is the first targeted T cell therapy to induce significant tumor regressions in challenging tumors such as those seen in ovarian cancer. We remain committed to developing DPX-Survivac for patients with significant unmet medical needs, and look forward to our upcoming discussions with regulatory authorities in the USA, Canada and Europe.”
Updated Clinical Response and Safety Data for DeCidE1
At the time of data cut-off, 53 patients were enrolled in the phase 1b clinical trial, including 14 from the 100 mg epacadostat dosing cohort and 39 from 300 mg epacadostat cohort. Based on 300 mg cohort results, IMV and Incyte agreed to stop dosing patients with epacadostat before completion of the study. Patients who completed at least one CT scan, as required per the trial protocol, were evaluable for response analysis.
71% of patients were evaluable for responses in the 100 mg cohort and 56% in the 300 mg dose cohort. At time of data cut-off, 8 participants remained on treatment and were being evaluated for clinical responses.
| Efficacy | Total target lesion size < 5 cm | |||||
