Mereo BioPharma Group plc, and Oncologie, Inc. have entered a global license agreement for the development and commercialization of navicixizumab, an anti-DLL4/VEGF bispecific antibody currently being evaluated in a Phase Ib study in combination with paclitaxel in advanced heavily pretreated ovarian cancer. Navicixizumab previously completed a Phase 1a monotherapy study in patients with various types of refractory solid tumors and is one of two product candidates Mereo acquired through its 2019 merger with OncoMed Pharmaceuticals, Inc. In October 2019, the U.S. FDA granted navicixizumab Fast Track designation and has agreed on the design of a study that could potentially support accelerated approval.

Under the license agreement, Oncologie will receive an exclusive worldwide license to develop and commercialize navicixizumab. Mereo will receive $4 million upfront with an additional $2 million conditional on a CMC (Chemistry, Manufacturing and Controls) milestone. Oncologie will be responsible for all future research, development and commercialization of navicixizumab. Additionally, Mereo will be eligible to receive as much as $300 million in future clinical, regulatory and commercial milestones, royalties on sales, as well as a negotiated percentage of sublicensing revenues.

“We believe Oncologie is expertly positioned to further advance navicixizumab through clinical development and towards potential commercialization,” said Dr. Denise Scots-Knight, chief executive officer of Mereo. “While we believe navicixizumab is an exciting oncology asset, we continue to focus our primary efforts on the development of our innovative rare disease portfolio including our lead product candidate setrusumab for the treatment of osteogenesis imperfecta, which continues to advance towards a pivotal Phase III pediatric study.”

“We believe navicixizumab is a strong strategic fit with our portfolio of innovative oncology assets, and we are excited to enter into this agreement with Mereo,” said Laura E. Benjamin, Ph.D., chief executive officer of Oncologie. “Navicixizumab has demonstrated promising activity in a Phase 1b monotherapy study of heavily pretreated ovarian cancer patients, as well as in other tumor types. 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.”