Foundation Medicine and PMV Pharma Announce Collaboration to Develop Companion Diagnostic for Rezatapopt, a First-In-Class, Investigational, Selective p53 Y220C Reactivator
29 Mai 2024 - 1:00PM
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
PMV Pharmaceuticals (NASDAQ:PMVP)
Graphique Historique de l'Action
De Août 2024 à Sept 2024
PMV Pharmaceuticals (NASDAQ:PMVP)
Graphique Historique de l'Action
De Sept 2023 à Sept 2024