Mereo BioPharma Reports on Recent Program Developments and Provides Financial Update - Seite 2

The ATALANTa study was funded by the National Center for Advancing Translational Sciences (NCATS) through the National Institutes of Health (NIH)-Industry Program for discovering new therapeutic uses for existing molecules.

In Europe, the Company has received guidance from the European Medicines Agency (EMA) that a Phase 3 primary endpoint of lung density by computed tomography (CT) scan with a relaxed p value (p<0.1) may, if the study is successful, be sufficient for full approval. In the US, the Company is continuing its interactions with the FDA and the Division of Clinical Outcomes Assessment (DCOA) regarding the use of a Patient Reported Outcome (PRO) as a primary Phase 3 endpoint.

The data from the ATALANTa study are expected to further support the ongoing partnering process for the alvelestat Phase 3 program.

Etigilimab (MPH-313)

On October 21, 2023, an update on the Company’s Phase 1b/2 study investigating the safety and efficacy of etigilimab (anti-TIGIT) in combination with nivolumab (anti-PD1) in recurrent/advanced solid tumors (ACTIVATE) was presented in a mini-oral session at the ESMO 2023 Congress in Madrid, Spain by Dr. Meredith McKean, Sarah Cannon Research Institute, USA. Of 40 evaluable patients presented in select cohorts, three complete responses (CRs), seven partial responses (PRs) and eleven stable disease (SDs) beyond 112 days (3.7 months) were noted. Seven patients showed clinical benefit for ≥ 335 days (11 months). The data show promising efficacy in PDL1 low patients with six of seven on study ≥ 335 days (11 months) being PDL1 negative or low and all having high PVR tumoral expression. Etigilimab in combination with nivolumab continues to be safe and well tolerated with no new safety signals noted. The last patient last dose was completed at the end of June 2023. The cervical cancer and uveal melanoma cohorts cleared the protocol Simon 2 Stage design interim futility monitoring bar for expansion to Stage 2 and were endorsed by an independent data monitoring committee for expansion.

Etigilimab, in combination with nivolumab, is in an ongoing investigator-led single-arm, two-stage, open-label Phase 1b/2 trial in a subtype of platinum-resistant recurrent ovarian cancer (clear cell ovarian cancer) at The University of Texas MD Anderson Cancer Center, financed by the Cancer Focus Fund. This trial is being led by Dr. Shannon Westin. Enrollment is currently being expanded from the initial 10 patients to 20 patients.