PMV Pharma Doses First Patient in Phase 1/2 Study of PC14586, a First-in-Class Precision Oncology Therapy That Targets Mutant...
2020年11月23日 - 10:00PM
PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology
company pioneering the discovery and development of small molecule,
tumor-agnostic therapies targeting p53 mutants, today announced
dosing of the first patient in its Phase 1/2 clinical trial
evaluating PC14586, the company’s investigational lead compound
that targets the Y220C mutant of p53. The trial will enroll up to
130 patients with advanced solid tumors that have the specific p53
Y220C variant.
"This is an important step forward in the battle
against the many cancers that are driven by a p53 mutation,” said
David Mack, Ph.D., President and Chief Executive Officer of PMV
Pharma. “Initiating our Phase 1/2 study represents a significant
milestone for PMV, as PC14586 is our first tumor-agnostic therapy
to enter the clinic. By selectively binding to the p53 Y220C
mutant, PC14586 is designed to reactivate the tumor suppressing
function of p53. We look forward to the opportunity to address the
significant unmet need for patients whose cancers have a p53 Y220C
mutation as we advance PC14586 in the clinic.”
The multi-center, single-arm Phase 1/2 study
will evaluate PC14586 in patients with advanced solid tumors with a
p53 Y220C mutation. Phase 1 will assess the safety, tolerability,
pharmacokinetics, and preliminary anti-tumor activity of PC14586.
Phase 2 will determine the overall response rate and duration of
response of PC14586 at a dose identified in Phase 1.
About p53
p53 plays a pivotal role in preventing abnormal
cells from becoming a tumor by inducing programmed cell death.
Mutant p53 takes on oncogenic properties that endow cancer cells
with a growth advantage and resistance to anti-cancer therapy. The
p53 Y220C mutation is associated with many cancers, including but
not limited to breast, non-small cell lung cancer, colorectal,
pancreatic, and ovarian cancers.
About PC14586
PC14586 is a first-in-class, small molecule, p53
reactivator designed to selectively bind to the crevice created by
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
advanced solid tumors that have a p53 Y220C mutation identified by
next generation sequencing. PC14586 was granted Fast Track
Designation by the U.S. Food and Drug Administration in October
2020.
For information on the Phase 1/2 trial, please
visit www.clinicaltrials.gov (NCT study identifier
NCT04585750).
About PMV
Pharma
PMV Pharma is a precision oncology company
pioneering the discovery and development of small molecule,
tumor-agnostic therapies targeting p53 mutants. p53 is mutated in
approximately half of all cancer. 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 the timing for patient
enrollment and success of its current clinical trial for PC14586.
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 Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission (the “SEC”) on November
13, 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.
Contact
For Investors:
Winston KungChief Financial Officerinvestors@pmvpharma.com
For Media:
Mariann Caprinomcaprino@pmvpharma.com(917) 242-1087
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