Summary of PMV Pharma Conference Call Company Overview - PMV Pharma was founded approximately eleven years ago by David Mack, Arne Levine, and Thomas Shank, focusing on harnessing the power of the p53 protein [3][4] - The company is currently advancing its Phase two registrational study for rizatapupt, targeting the TP53Y220C mutation in solid tumors [3][4] Current Programs and Clinical Trials - The Phase one program evaluated rizatapupt, leading to a successful transition into Phase two, with enrollment expected to complete by the end of this year [4][36] - An interim analysis is planned for mid-year, sharing data from around 50 patients, including 20 with ovarian cancer [4][36] - The Y220C mutation occurs in approximately 1% of all solid tumors and 3% in ovarian cancer, driving the design of a basket study across multiple tumor types [9][10] Efficacy and Safety Data - Preliminary Phase one data showed a 38% confirmed overall response rate across six tumor types, with a median duration of response (DOR) of seven months [11][35] - Safety profile was favorable, primarily grade one and two treatment-related adverse events, mainly gastrointestinal toxicities, which were mitigated by food [12][35] Study Design and Regulatory Alignment - The FDA provided alignment on the Phase two study design and recommended dose in July 2023, facilitating a potential registration path [22][23] - The Phase two study aims for a 30% response rate in ovarian cancer patients, with a confidence interval lower bound excluding 12% [24][31] Enrollment and Future Plans - Enrollment is on track, with 114 patients expected by year-end, including 42 in the ovarian cancer cohort [36][43] - NDA submission is anticipated by the end of next year, contingent on follow-up data from the ovarian cancer cohort [42][54] Financial Position - PMV Pharma has approximately $165 million in cash, supporting operations until the end of next year, covering the NDA submission timeline [54][56] Future Development - The company is working on an undisclosed target in lead optimization, with hopes for an IND submission in 2026 [51][52] - There are considerations for combination studies with KRAS inhibitors, although no formal announcements have been made yet [46][47] Key Takeaways - PMV Pharma is addressing a significant unmet medical need in cancer treatment through innovative approaches targeting p53 mutations [58] - The excitement around the interim analysis and ongoing enrollment reflects strong interest from clinical centers [59]