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PMV Pharmaceuticals to Present Updated Phase 1 Data on PC14586 at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Key Takeaway: PMV Pharmaceuticals announced that updated Phase 1 clinical data for its investigational therapy PC14586 will be presented at the 2023 AACR-NCI-EORTC conference in Boston. This therapy is focused on treating patients with advanced solid tumors that have a TP53 Y220C mutation. Additionally, the company will host a webinar to discuss the data and provide a regulatory update. The PYNNACLE study aims to determine the maximum tolerated dose of PC14586 and evaluate its efficacy.
Price reaction · baseline $6.03 (2023-09-19 close) · hit after-hours · clean, no other PMVP news in the window
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day 3
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POSITIVE FACTORS

  • Updated Phase 1 data shows progress in PC14586 development.
  • PMV Pharmaceuticals successfully presents findings at a major conference.
  • FDA's Fast Track designation for PC14586 highlights its potential.

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Best trade, last catalyst
+76%
120-day peak, hindsight
Typical move
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Low dilution risk
Lead asset
rezatapopt
Phase 1 · Advanced Solid Tumor

Full Press Release Details

Late-breaking poster presentation to highlight updated Phase 1 clinical data of PC14586, a first-in-class precision oncology investigational therapy, in patients with advanced solid tumors that have a TP53 Y220C mutation
Company to host KOL webinar on October 12, 2023 to review data and provide regulatory update
PRINCETON, N.J., Sept. 20, 2023 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today announced that updated Phase 1 clinical data from its ongoing Phase 1/2 PYNNACLE study of PC14586 will be presented in a late-breaking poster session at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place October 11-15, 2023, in Boston, Massachusetts.
“We are excited to share updated data from our ongoing Phase 1/2 PYNNACLE clinical trial of PC14586 at this year’s AACR-NCI-EORTC conference,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We look forward to presenting and continuing to progress the PC14586 development program.”
PMV will host a KOL webinar for the investment community on Thursday, October 12, 2023 at 4:00 PM ET to review the data and to provide a regulatory update. The webinar will feature presentations by Aparna Parikh, M.D. M.S., Director of the Global Cancer Care Program at Mass General Hospital Cancer Center, and by PMV management.
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-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., as part of Concurrent Session 8: Targeted and Immunotherapy Approaches Against p53 at 10:00 AM ET on Saturday, October 14, 2023.
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 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 Recommended Phase 2 Dose (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).
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.
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 Arnold Levine, Ph.D., when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize more than four decades of p53 biology, PMV Pharma combines unique biological understanding with pharmaceutical development focus. PMV Pharma is headquartered in Princeton, 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 the overall 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 clinical stage company, the potential for clinical trials of PC14586 or any future clinical trials of other product candidates to differ from preclinical, preliminary or expected results, the Company’s ability to fund operations, and the impact that the current COVID-19 pandemic will have on the Company’s clinical trials, supply chain, and operations, as well as those risks and uncertainties set forth in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 1, 2023, and its other filings filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
PMV Pharmaceuticals, Inc.

Frequently Asked Questions

What is PC14586?

PC14586 is a first-in-class, small molecule, precision oncology therapy targeting the p53 Y220C mutation.

When will the updated Phase 1 data be presented?

The updated Phase 1 data will be presented on October 12, 2023, at the AACR-NCI-EORTC conference.

What is the aim of the PYNNACLE study?

The PYNNACLE study aims to evaluate the safety and efficacy of PC14586 in patients with advanced solid tumors.

What is the webinar about on October 12?

The webinar will review updated data from the clinical trial and provide a regulatory update.

Who is leading the poster presentation?

The poster presentation is led by Alison M. Schram, M.D., from Memorial Sloan Kettering.

Last updated: Sep 20, 2023