Mereo BioPharma meets with FDA to fast-track ovarian cancer treatment approval

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Mereo BioPharma Group said it had held a successful meeting with the US Food and Drug Administration regarding a potential accelerated approval for navicixizumab for the treatment of patients with advanced ovarian cancer.

Navicixizumab was an anti-DLL4/VEGF bispecific antibody and one of two product candidates Mereo acquired through its April 2019 merger with OncoMed Pharmaceuticals.

The treatment had completed a Phase 1a monotherapy study in patients with various types of refractory solid tumors.

It was currently being evaluated in an ongoing Phase 1b study in combination with paclitaxel in patients with advanced platinum-resistant ovarian cancer.

In the so-called Type B meeting, Mereo and the FDA discussed, and agreed in principle, an outline for the design of a Phase 2 clinical trial.

The trial could potentially support the accelerated approval of navicixizumab in patients with ovarian cancer who had become resistant to their prior therapies.

At 1:26pm: (LON:MPH) Mereo Biopharma Group Ltd share price was +1p at 42.5p