Benzinga | Oct 19, 2020 07:11AM EDT

Mereo BioPharma Announces FDA Clearance to Proceed into a Phase 1b/2 study for Etigilimab

Mereo BioPharma Group plc (NASDAQ:MREO, AIM: MPH))) ("Mereo" or "the Company"), a clinical stage biopharmaceutical company focused on oncology and rare diseases, today announced that the U.S. Food and Drug Administration has cleared an investigational new drug (IND) application to proceed with a Phase 1b/2 study for the Company's lead oncology product candidate etigilimab. Etigilimab is a novel IgG1 monoclonal antibody against TIGIT (T-cell immunoreceptor with Ig and ITIM domains), a next generation checkpoint receptor shown to block T-cell activation and the body's natural anti-cancer immune response.

Mereo is on track to initiate the Phase 1b/2 basket study in the fourth quarter of 2020. The study will evaluate etigilimab in combination with an anti-PD-1 initially in approximately 100 patients with a defined series of tumor types, including biomarker enriched and rare tumor cohorts. The study will incorporate flat dosing (for patients 50 kg and higher) which is based on data from Mereo's previous Phase 1a and Phase 1b combination studies with etigilimab.

Dr. John Lewicki, Chief Scientific Officer of Mereo, said: "Recent clinical data regarding anti-TIGIT therapies in combination with PDL-1/PD-1 inhibition have been promising. We designed etigilimab as a novel IgG1 which blocks TIGIT signalling while retaining an intact effector function and we believe our development approach is differentiated. We have selected the tumor types for our planned Phase 1b/2 basket combination study based on biomarker screening of large collections of different tumor samples and correlating these with suboptimal responses to anti- PDL-1/PD-1. We've also included tumor types where we saw evidence of activity in our previous Phase 1a/1b study. We look forward to initiating the study this quarter and providing additional details during our planned virtual R&D day."

In November 2020, Mereo plans to host a virtual R&D day featuring external experts to review the etigilimab development program, including the design and biomarker strategy of the Phase 1b/2 basket combination study. Mereo also plans to provide an overview of its rare disease product pipeline. Further information including the date/time of the virtual R&D day will be announced in the coming weeks.