BOSTON – November 28, 2016 — OncoPep, Inc. announced that a Phase 1b clinical trial is underway to evaluate PVX-410, a multi-peptide therapeutic cancer vaccine, as an adjuvant treatment in patients who have completed all planned therapy for stage II or III triple negative breast cancer (TNBC). The study, led by Steven Isakoff, M.D., Ph.D. at Massachusetts General Hospital, will assess the safety and tolerability of PVX-410 in combination with the checkpoint inhibitor durvalumab.
“In this Phase 1b clinical trial, we are looking to evaluate the safety of PVX-410 alone and in combination with durvalumab, and to determine whether the vaccine and durvalumab can work together to assist immune system recognition of TNBC,” said Dr. Isakoff, Associate Director for Breast Cancer Clinical Research at the Massachusetts General Hospital Cancer Center and Assistant Professor in Medicine at Harvard Medical School. “We are hopeful that this approach will allow immune system recognition of cancer-associated antigens and result in a targeted immune response that can be utilized as a possible adjuvant treatment for stage II or III TNBC.”
“The initiation of this Phase 1b clinical trial of PVX-410 in TNBC marks an important milestone in OncoPep’s development,” said Doris Peterkin, Chief Executive Officer of OncoPep. “We are now developing PVX-410 in two oncology indications, TNBC and smoldering multiple myeloma, in which we are hopeful that the vaccine will provide enhanced immune targeting of cancer cells for improved patient outcomes.”
The multi-center, open label Phase 1b study is designed to evaluate the safety, tolerability, and immune response to PVX-410 alone and in combination with durvalumab in an adjuvant setting in patients who have completed all planned therapy for stage II or III TNBC. Patients will receive six bi-weekly intramuscular injections of PVX-410, which will be given in combination with an intravenous infusion of durvalumab on the day of the 4 th and 6 th PVX-410 injection. The study is expected to enroll approximately 20 patients at multiple treatment centers, including Massachusetts General Hospital, Beth Israel Deaconess Medical Center, and Dana-Farber Cancer Institute. More information on the trial can be found at clinicaltrials.gov, identifier number NCT02826434.