OncoPep Announces Initiation of Phase 1b Clinical Trial of PVX-410 in Metastatic Triple Negative Breast Cancer

BOSTON – February 22, 2017 — OncoPep, Inc. today announced the initiation of a Phase 1b clinical trial evaluating its investigational vaccine product PVX-410for the treatment of patients with metastatic triple negative breast cancer (TNBC) who are human leukocyte antigen A2 positive (HLA-A2+). The investigator-sponsored study led by Steven Isakoff, M.D., Ph.D., at Massachusetts General Hospital, will assess the safety, tolerability and immune response to PVX-410 alone and in combination with the checkpoint inhibitor pembrolizumab (Keytruda®, Merck, Inc.). PVX-410is a multi-peptide investigational therapeutic cancer vaccine which may act to help stimulate an immune response against cancer cells.

“This study will help determine if PVX-410and pembrolizumab administered together can help the body’s immune system to recognize and potentially reduce or stabilize tumors in patients with metastatic triple negative breast cancer,” 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. “TNBC continues to be a disease with poor prognosis that disproportionally affects premenopausal women and African-American women and new treatment options beyond chemotherapy are desperately needed. I am pleased to be involved with this research initiative and look forward to assessing PVX-410in this unique combination.”

The open label, multi-center Phase 1b study is designed to evaluate the safety and immune response to PVX-410alone and in combination with pembrolizumab in HLA-A2+ patients with metastatic TNBC. Patients will receive weekly injections of PVX-410for six consecutive weeks, followed by booster PVX-410vaccine doses at Week 10 and Week 28. Pembrolizumab will be administered every three weeks intravenously starting with Week 1. The trial is expected to enroll a total of approximately 20 patients at multiple trial sites, including Massachusetts General Hospital, Beth Israel Deaconess Medical Center and the Dana Farber Cancer Institute. More information on the trial can be found at clinicaltrials.gov, identifier number NCT03362060.

“OncoPep is now advancing multiple clinical studies of its investigational vaccine product PVX-410 as a stand-alone and combination treatment, including this new study with pembrolizumab in metastatic triple negative breast cancer and an on-going investigator-sponsored study in combination with durvalumab (Infinzi®, MedImmune/AstraZeneca), an antibody against the PD-L1 ligand, in the adjuvant setting for patients with stage II or stage III triple negative breast cancer,” said Doris Peterkin, Chief Executive Officer of OncoPep. “We are thrilled with the progress of our cancer immunotherapy program and the initiation of this Phase 1b investigator sponsored clinical trial in metastatic triple negative breast cancer and to be working with Dr. Isakoff’s team.” More information on the adjuvant TNBC trial of PVX-410 in combination with durvalumab can be found at clinicaltrials.gov, identifier number NCT02826434.