OncoQuest has entered into a collaborative agreement with Tesaro to conduct a proof-of-concept clinical trial evaluating the combination of oregovomab (MAb B43.13) with Zejula (niraparib) in recurrent ovarian cancer.
Oregovomab is a high-affinity monoclonal antibody designed to bind to the tumor-associated antigen CA125 and initiate a cascade of immune responses against this protein. CA125 is expressed at the surface of epithelial ovarian cancer cells, but it is also shed into circulation.
OncoQuest is studying if combining standard of care chemotherapy — Paraplatin (carboplatin) plus Taxol (paclitaxel) — with oregovomab can improve outcomes when compared to chemotherapy alone.
“We are excited to work with TESARO, an oncology-focused biopharmaceutical company, to evaluate the possible synergistic effects of combining Zejula with oregovomab in this important clinical setting,” Madi Madiyalakan, chief executive officer of OncoQuest, said in a press release.
The company had already shown that the combination delayed disease progression when given to advanced ovarian cancer patients following surgery.
The findings, presented at the American Society of Clinical Oncology meeting in June 2017, were included in a poster titled, “A randomized phase II study assessing an optimized schedule of oregovomab (O) anti-CA125 vaccination with carboplatin paclitaxel (CP) relative to CP alone in front-line treatment of optimally cytoreduced stage III/IV ovarian cancer (EOC).”
Zejula is an oral, once-daily PARP 1/2 inhibitor that is indicated in the United States for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
Since April 2017, Zejula is part of the National Comprehensive Cancer Network (NCCN) Practice Guidelines in Oncology Ovarian Cancer v. 1.2017.
Per the terms of the agreement, OncoQuest will sponsor the Phase 1/2 clinical trial and Tesaro will provide clinical supplies of Zejula as well as partial funding. The trial is anticipated to begin in 2018.
This will be the third Phase 1/2 clinical study evaluating oregovomab in combination with other drugs in the recurrent ovarian cancer setting. Two other trials are currently ongoing: one evaluating oregovomab in combination with the immune checkpoint inhibitor Opdivo (nivolumab), and one evaluating oregovomab in combination with Hiltonol (Poly-ICLC), an investigational TLR3 agonist.