Mereo BioPharma has licensed its experimental therapy navicixizumab (OMP-305B83) — designed to treat advanced, heavily pretreated ovarian cancer — to Oncologie for worldwide development and commercialization.
Under the terms of the agreement, Mereo will get an upfront payment of $4 million. That will be followed by a $2 million outlay contingent upon a milestone known as CMC, or chemistry, manufacturing and controls — the ability to produce, analyze, and store a product.
Mereo also stands to get $300 million in future clinical, regulatory and commercial milestones, plus royalties on global annual net sales and a negotiated percentage of certain sublicensing revenues.
Oncologie will be responsible for all future research, development, and commercialization of navicixizumab.
“We believe Oncologie is expertly positioned to further advance navicixizumab through clinical development and towards potential commercialization,” Denise Scots-Knight, PhD, CEO of Mereo, said in a press release.
The U.S. Food and Drug Administration (FDA) granted fast track designation to navicixizumab in October as a potential therapy for heavily pretreated ovarian cancer.
The treatment is designed for patients who have received more than two prior therapies and/or prior bevacizumab — a therapeutic antibody against the vascular endothelial growth factor (VEGF) protein, which is necessary for the formation of new blood vessels.
Navicixizumab is a bispecific antibody that targets both VEGF and its ligand, Delta-like ligand 4 (DLL4). DLL4 is involved in the development of cancer stem cells and the formation of new blood vessels essential to tumor growth.
The fast track designation was based on positive results from a Phase 1a study (NCT02298387) and an ongoing Phase 1b study (NCT03030287) evaluating navicixizumab in people with advanced heavily pretreated ovarian cancer.
The Phase 1a study included 66 patients with refractory solid tumors who received escalating doses of navicixizumab once every three weeks. Among the 12 ovarian cancer patients included in the study, three (25%) attained a partial response of a decrease of at least 30% in tumor size, while four (33%) had stable disease.
The Phase 1b trial is now assessing a combination of navicixizumab plus the chemotherapy agent Taxol (paclitaxel) in people with platinum-resistant ovarian, fallopian, or primary peritoneal cancer who received three or more prior therapies and/or bevacizumab.
At the time of the last analysis, the trial had included 44 of the 60 estimated participants, 41% of whom responded to treatment. They also lived a median of 7.3 months without signs of disease worsening.
The FDA has agreed in principle on an outline for a Phase 2 clinical trial that could potentially support accelerated approval of navicixizumab in a heavily pretreated, platinum-resistant ovarian cancer population.
“We believe navicixizumab is a strong strategic fit with out portfolio of innovative oncology assets, and we are excited to enter into this agreement with Mereo,” said Laura E. Benjamin, PhD, CEO of Oncologie.
“We seek to leverage the strong development and regulatory progress Mereo has already made to continue its development and ultimately make this investigational therapy available to patients as quickly as possible,” Benjamin said.