OncoPep has begun a Phase Ib clinical trial to assess PVX-410 for the treatment of patients with metastatic triple negative breast cancer (TNBC) that are human leukocyte antigen A2 positive (HLA-A2+).
This open-label multi-centre trial is led by the Massachusetts General Hospital Cancer Centre's associate director of breast cancer clinical research Dr Steven Isakoff.
The trial expects to enrol around 20 patients across multiple sites, including Massachusetts General Hospital, Beth Israel Deaconess Medical Centre and the Dana Farber Cancer Institute.
It intends to examine the safety and immune response to PVX-410 alone and in combination with pembrolizumab in HLA-A2+ patients with metastatic TNBC.
During the trial, patients will be given weekly injections of PVX-410 for six consecutive weeks, followed by booster PVX-410 vaccine doses at weeks ten and 28.
Patients will also receive Pembrolizumab every three weeks intravenously beginning in week one.
Isakoff said: “This study will help determine if PVX-410 and pembrolizumab administered together can help the body's immune system to recognise and potentially reduce or stabilise tumours in patients with metastatic triple negative breast cancer.
“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.”
OncoPep’s PVX-410 is an investigational therapeutic cancer vaccine that comprises four peptides from unique regions of three tumour-associated antigens, which may act to help stimulate an immune response to the targeted tumour cell.
It has previously received orphan drug designation from the US Food and Drug Administration (FDA) in 2013 for the treatment of multiple myeloma.