Investor Event
Management will host an investor event via webcast on June 7, 2022, at 6:30 pm CDT to discuss the PC14586 Phase 1 data. The event will feature a presentation by Dr. Dumbrava who will review the data presented at ASCO.
To listen to the webcast and view the accompanying slide presentation, please refer to the Events and Presentations section of the PMV Pharma website.
About the PYNNACLE Study
PYNNACLE is an open-label, multicenter Phase 1/2 clinical study assessing safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of PC14586 in patients with advanced solid tumors harboring a p53 Y220C mutation. A total of 41 patients were enrolled as of May 10, 2022; 36 patients with measurable disease at baseline including 33 patients determined to be eligible for response evaluation. During the Phase 1 dose-escalation portion of the study, multiple dose levels of PC14586 were evaluated (150 mg QD, 300 mg QD, 600 mg QD, 1150 mg QD, 1500 mg QD, 2000 mg QD, 2500 mg QD, and 1500 mg BID). Preliminary efficacy was assessed by RECIST v1.1. A recommended Phase 2 dose will be selected at the end of Phase 1. For more information on the Phase 1/2 PYNNACLE study (PMV-586-101), 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 crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. Fast Track designation has been granted by the Food and Drug Administration (FDA) for evaluating PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.
About PMV Pharma
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. p53 mutations are found in approximately half of all cancers. The field of p53 biology was established by our co-founder Dr. Arnold Levine when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with pharmaceutical development focus. PMV Pharma is headquartered in Cranbury, New Jersey. For more information, please visit www.pmvpharma.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company’s future plans or expectations for PC14586, including expectations regarding success of its current clinical trial for PC14586 and any future commercialization plans for the product candidate; and the future plans or expectations for the Company’s discovery platform for its other early-stage and clinical candidates. Any forward-looking statements in this statement are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company’s product candidate development activities and planned clinical trials, the Company’s ability to execute on its strategy and operate as an early