Foundation Medicine and PMV Pharma Announce Collaboration to Develop Companion Diagnostic for Rezatapopt, a First-In-Class, Investigational, Selective p53 Y220C Reactivator

Rhea-AI Summary

Foundation Medicine and PMV Pharmaceuticals have partnered to develop FoundationOne®CDx, a genomic profiling test, as a companion diagnostic for PMV Pharma’s investigational therapy, rezatapopt. Rezatapopt targets the TP53 Y220C mutation found in about 1% of solid tumors, often deemed undruggable despite its prevalence in 50% of cancers. This collaboration utilizes Foundation Medicine's real-world data and genomic tests to support PMV Pharma's clinical trials. Rezatapopt received Fast Track designation from the FDA and is undergoing Phase 2 trials.

Positive

• Foundation Medicine and PMV Pharma partnership aims to develop a first-in-class therapeutic option.
• Rezatapopt targets TP53 Y220C mutation, a prevalent issue in cancer treatments.
• Potential new therapeutic option for high unmet medical needs.
• FDA Fast Track designation for rezatapopt suggests a faster approval process.
• Foundation Medicine's genomic profiling tests support personalized treatment decisions.

Negative

• Rezatapopt is still investigational, meaning it is not yet proven effective or safe.
• Potential risks associated with the ongoing Phase 2 clinical trial.
• TP53 Y220C mutation affects only 1% of solid tumor patients, limiting the target population.

Insights

Oncology Doctor

The partnership between Foundation Medicine and PMV Pharmaceuticals to develop a companion diagnostic for rezatapopt is a significant step in treating TP53 Y220C mutations, one of the most prevalent and challenging mutations in oncology. This mutation occurs in 1 of all solid tumors, which translates to a substantial patient population that has historically been difficult to treat. Rezatapopt, designed to reactivate the p53 function, could provide a much-needed therapeutic option for patients with locally advanced or metastatic solid tumors harboring this mutation.

The FDA's Fast Track designation for rezatapopt highlights its potential to address an unmet clinical need. Fast Track is a process designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. This designation can expedite the drug's availability to patients, which is important given the limited treatment options currently available for this mutation.

For retail investors, the progress of rezatapopt through clinical trials will be a key indicator of its potential success. The ongoing Phase 2 PYNNACLE trial will provide critical data on the drug's efficacy and safety. If successful, rezatapopt could become a cornerstone therapy in treating TP53 Y220C mutations, driving significant value for PMV Pharma and its stakeholders.

Financial Analyst

From a financial perspective, this collaboration between Foundation Medicine and PMV Pharmaceuticals could present substantial opportunities. Foundation Medicine’s comprehensive genomic profiling tests, particularly FoundationOne CDx, are already established in the market. If the companion diagnostic and rezatapopt receive FDA approval, this would create a new revenue stream for both companies.

For PMV Pharmaceuticals, the success of rezatapopt as a first-in-class therapy would not only provide a new treatment option for cancer patients but also significantly enhance their market position and valuation. Given that TP53 mutations are present in 50 of cancer cases, albeit in different forms, the potential market for a successful therapy is vast.

Retail investors should monitor the development milestones and regulatory updates closely. Positive trial results and subsequent FDA approval would likely lead to a rise in PMV Pharma’s stock price, reflecting the drug's commercial potential. However, it is essential to consider the risks associated with clinical trials, as any setbacks could negatively impact the stock.

BOSTON & PRINCETON, N.J.--(BUSINESS WIRE)-- Foundation Medicine, Inc. and PMV Pharmaceuticals, Inc. (NASDAQ: PMVP; “PMV Pharma”) today announced a partnership to develop Foundation Medicine’s tissue-based comprehensive genomic profiling test, FoundationOne®CDx, as a companion diagnostic for PMV Pharma’s rezatapopt, a first-in-class, investigational therapy for patients with locally advanced or metastatic solid tumors that have a TP53 Y220C mutation.

Across all human cancers, TP53 is the most frequently altered gene, with mutations occurring in approximately 50% of cancer cases.¹ Historically, TP53 mutations have been considered undruggable despite its prevalence across cancers.² TP53 Y220C mutation is one of the most frequently observed TP53 mutations, occurring in approximately 1% of all solid tumors.³ PMV Pharma is developing rezatapopt, a small molecule, to reactivate the p53 function in an advanced cancer patient population harboring a TP53 Y220C mutation.

“The innovative science driven by PMV Pharma’s efforts specific to TP53 Y220C has the potential to offer a new therapeutic option for patients in this area of high unmet medical need,” said Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. “We’re proud to provide our high-quality tissue-based genomic test, along with real-world data from our Flatiron Health-Foundation Medicine Clinico-Genomic Database, to support PMV Pharma as they develop this exciting new treatment option.”

Rezatapopt (PC14586) is an investigational, first-in-class, selective p53 reactivator designed to stabilize p53 Y220C proteins. The TP53 Y220C mutation creates a small pocket in the p53 protein, making it thermally unstable and unable to effectively interact with DNA. Rezatapopt is an orally available small molecule designed to selectively bind to a pocket in the p53 Y220C protein, leading to the restoration of the wild-type p53 tumor suppressor function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a TP53 Y220C mutation, and is the subject of the ongoing registrational, tumor-agnostic PYNNACLE Phase 2 clinical trial. For more information about the Phase 2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offers physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. If the CDx and separately the therapy are approved, FoundationOne CDx would be the first companion diagnostic to identify patients with TP53 Y220C mutations who may be eligible for rezatapopt.

Foundation Medicine^® and FoundationOne^® are registered trademarks of Foundation Medicine, Inc.

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on LinkedIn and X.

About FoundationOne®CDx

FoundationOne®CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com.

About Rezatapopt

Rezatapopt (PC14586) is an investigational, first-in-class, small molecule, p53 reactivator designed to selectively bind to a pocket in the p53 Y220C mutant protein leading to the restoration of the wild-type p53 tumor suppressor function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with 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. TP53 mutations are found in approximately half of all cancers. Our co-founder, Dr. Arnold Levine, established the field of p53 biology 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 a pharmaceutical development focus. PMV Pharma is headquartered in Princeton, New Jersey. For more information, please visit www.pmvpharma.com.

¹ Priestley P, Baber J, Lolkema MP, et al. Pan-cancer whole-genome analyses of metastatic solid tumours. Nature. 2019 ; 575(7781) : 210–216. https://doi.org/10.1038/s41586-019-1689-y

² Hassin O, Oren M. Drugging p53 in cancer: one protein, many targets. Nat Rev Drug Discov. 2023; 22(2):127–144. https://doi.org/10.1038/s41573-022-00571-8

³ The prevalence of the TP53 Y220C and KRAS mutations across different diseases was analyzed by the FoundationInsights® web-based software platform to query a pan-solid tumor cohort of 367,651 US, consented for research patients in the FoundationCore® Database that received Foundation Medicine’s Commercial Tissue or Heme assays between 1/1/2012 and 12/31/2020.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240529460179/en/

Media:

For Foundation Medicine

Danielle Johns, 845-304-7408

newsroom@foundationmedicine.com

For PMV Pharma

Investors:

Tim Smith

Senior Vice President, Head of Corporate Development and Investor Relations

investors@pmvpharma.com

Media:

Kathy Vincent

Greig Communications

kathy@greigcommunications.com

Source: Foundation Medicine

FAQ

What is the focus of the PMV Pharma and Foundation Medicine collaboration?

The collaboration focuses on developing FoundationOne®CDx as a companion diagnostic for PMV Pharma’s investigational therapy, rezatapopt.

What is rezatapopt?

Rezatapopt is an investigational, first-in-class therapy designed to reactivate p53 function in patients with TP53 Y220C mutations.

What mutation does rezatapopt target?

Rezatapopt targets the TP53 Y220C mutation, found in approximately 1% of solid tumors.

What is the significance of the TP53 Y220C mutation?

The TP53 Y220C mutation creates a small pocket in the p53 protein, making it unstable and unable to interact effectively with DNA.

What stage of clinical trial is rezatapopt currently in?

Rezatapopt is currently in the Phase 2 clinical trial stage.

Has rezatapopt received any special designations from the FDA?

Yes, rezatapopt has received Fast Track designation from the FDA.

What is FoundationOne®CDx?

FoundationOne®CDx is a comprehensive genomic profiling test developed by Foundation Medicine.

What is the target population for rezatapopt?

The target population for rezatapopt includes patients with locally advanced or metastatic solid tumors harboring the TP53 Y220C mutation.