The company received fast track designation from the US Food and Drug Administration for its treatment navicixizumab.
Mereo BioPharma Group (NASDAQ:MREO) has announced that the US Food and Drug Administration (FDA) has granted it fast track designation for navicixizumab.
As quoted in the press release:
Navicixizumab is an anti-DLL4/VEGF bispecific antibody and one of two product candidates Mereo acquired through its April 2019 merger with OncoMed Pharmaceuticals, Inc.
“We are pleased that the FDA continues to recognize the potential of navicixizumab to become a viable new treatment option for patients with platinum-resistant ovarian cancer who failed multiple other therapies,” said Jill Henrich, Senior Vice President of Regulatory Affairs at Mereo BioPharma. “This designation follows our successful Type B End of Phase 1 meeting with the FDA held in July 2019 regarding a potential pathway for accelerated approval for navicixizumab where the FDA agreed in principle on an outline for a Phase 2 clinical trial that could potentially support accelerated approval of navicixizumab in patients with ovarian cancer who have become resistant to prior therapies.”
Navicixizumab has completed a Phase 1a monotherapy study in patients with various types of refractory solid tumors and is currently being evaluated in an ongoing Phase 1b study in combination with paclitaxel in patients with advanced heavily pretreated ovarian cancer. In line with the Company’s strategy, a range of strategic partnering discussions have been initiated to provide additional funding for the navicixizumab program.