PMV Pharmaceuticals (PMVP) Oppenheimer 35th Annual Healthcare Life Sciences Conference (Virtual) 2025 summary

Company background and scientific focus

• Founded in 2013 to develop small molecule drugs restoring wild-type activity to mutant p53, with lead candidate rezatapopt in a Phase 2 registrational trial.

• Focused on hotspot p53 mutants, each requiring unique screening campaigns due to distinct protein structures.

• Pipeline expanded to include targets in the p53 pathway, with a new development candidate to enter IND-enabling studies in 2024 and first-in-human studies anticipated in 2026.

Clinical development and trial design

• Phase 1 data for rezatapopt showed a 38% confirmed ORR at 2,000 mg QD with food, with responses across six cancer types.

• Phase 2 PYNNACLE trial enrolls five cohorts, emphasizing ovarian cancer (42 patients) and four other solid tumor types (18 patients each), aiming for a tumor-agnostic label.

• Interim analysis in mid-2024 will present data from at least 30 patients with 18 weeks of follow-up, including all cohorts.

Regulatory and commercial strategy

• Initial NDA submission planned for end of 2026, likely starting with ovarian cancer and expanding to tumor-agnostic indications.

• Tumor-agnostic approval strategy follows industry precedent, with strongest data in ovarian cancer driving initial submission.

• Objective response rate (ORR) and duration of response (DOR) are primary endpoints, with a target median DOR of six months; Phase 1 showed a seven-month median DOR.