On October 11, 2023 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported that it will present updated Phase 1 data from the ongoing Phase 1/2 PYNNACLE study of PC14586 in a late-breaking poster session at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), taking place October 11-15, 2023, in Boston, Massachusetts (Press release, PMV Pharma, OCT 11, 2023, View Source [SID1234635856]). The poster will contain updated clinical data from the study as of September 5, 2023.

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The abstract, containing data with a May 1, 2023 cutoff, was published today and is available for conference registrants on the AACR (Free AACR Whitepaper)-NCI-EORTC 2023 Conference app.

Poster presentation details:

Title: Updated Phase 1 results from the PYNNACLE Phase 1/2 study of PC14586, a selective p53 reactivator, in patients with advanced solid tumors harboring a TP53 Y220C mutation
Session Date and Time: 12:30 PM – 4:00 PM ET on Thursday, October 12, 2023
Session Title: Poster Session A
Lead Author: Alison M. Schram, M.D., Memorial Sloan Kettering Cancer Center
Abstract Number: LB_A25
Additional PC14586 Presentations at AACR (Free AACR Whitepaper)-NCI-EORTC Conference

The updated PYNNACLE clinical trial data will also be discussed by Leila Alland, M.D., Chief Medical Officer of PMV Pharma, during the Chemistry in Cancer Research Town Hall at 6:00 PM ET on Friday, October 13, 2023, and by Aparna Parikh, M.D, M.S., Director of the Global Cancer Care Program at Mass General Hospital Cancer Center, as part of Concurrent Session 8: Targeted and Immunotherapy Approaches Against p53 at 10:00 AM ET on Saturday, October 14, 2023.

KOL Webinar

PMV will host a KOL webinar via webcast on Thursday, October 12, 2023 at 4:00 PM ET to review the data and to provide a regulatory update. The event will feature presentations by Dr. Parikh and by PMV management.

To register for the event please click here.

About the PYNNACLE Clinical Trial

The ongoing Phase 1/2 PYNNACLE study is evaluating PC14586 in patients with advanced solid tumors harboring a p53 Y220C mutation. The primary objective of the Phase 1 portion of the trial is to determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PC14586 when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers will also be assessed. Phase 2 will be an expansion study with the primary objective of evaluating the efficacy of PC14586 at the RP2D in patients with TP53 Y220C advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).

About PC14586

PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.