Prelude Therapeutics Announces Publication of Abstract for Presentation at the European Society of Medical Oncology (ESMO) Congress 2024
09 September 2024 - 1:30PM
Prelude Therapeutics Incorporated (Nasdaq: PRLD) (“Prelude” or the
“Company”), a clinical-stage precision oncology company, today
announced the publication of an abstract regarding PRT3789 at the
European Society of Medical Oncology (ESMO) Congress 2024 taking
place in Barcelona, Spain September 13-17, 2024. The abstract can
be found on the ESMO 2024 website Registration | ESMO Congress 2024
“We are excited for the opportunity to share the first ever
clinical data of a novel, highly-selective SMARCA2 degrader,”
stated Jane Huang, M.D., President and Chief Medical Officer of
Prelude. “Patients whose cancer has a SMARCA4 mutation have limited
treatment options and generally very aggressive disease. Although
PRT3789 as a first-in-class molecule targeting a novel mechanism is
early in its development, we are highly encouraged by the safety
profile, target engagement and clinical activity we have seen to
date.”
PRT3789 is a potent and highly selective, first-in-class SMARCA2
degrader, in Phase 1 clinical development in biomarker selected
SMARCA4 mutant patients. Enrollment remains on track, and the
Company expects to conclude monotherapy dose escalation by year end
2024 and identify a recommended Phase 2 dose. In addition,
enrollment of patients into back-fill cohorts enriched for NSCLC
and SMARCA4 loss-of-function mutations is ongoing. Objectives for
this first Phase 1 clinical study are to establish the safety and
tolerability profile of PRT3789 as both monotherapy and in
combination with docetaxel, evaluate activity, pharmacokinetics and
pharmacodynamics and determine a dose and potential indications for
advancement into a registrational clinical trial.
Oral presentation title: First Clinical Results
from a Phase 1 Trial of PRT3789, a First-in-Class Intravenous
SMARCA2 Degrader, in Patients with Advanced Solid Tumors with a
SMARCA4 Mutation.
Observations in the abstract include:
- As of the March 7, 2024 data cutoff date, 40 pts had been
enrolled (NSCLC [18], pancreatic [5], breast [3], esophageal [2],
other [12]; 55% have loss-of-function mutations;
- Dose escalation had proceeded through 6 levels, from 24-212 mg,
with 2 backfill cohorts opened;
- No DLTs or study drug-related SAEs have been reported;
- The most common AEs reported, of any grade or relatedness, are
nausea (25%), constipation and dyspnea (each 17.5%), decreased
appetite and fatigue (each 15%), and anemia (12.5%);
- Dose-related increases in AUC were observed;
- Dose-dependent decreases in SMARCA2 levels were seen at all
doses with a trend for increasing depth and duration with
increasing doses;
- Minimal effects on SMARCA4 levels were seen;
- Clinical activity of PRT3789 therapy noted to date includes
RECIST partial responses, tumor shrinkage and prolonged stable
disease (longer than response to most recent therapy) in patients
with advanced, heavily pretreated esophageal cancer and NSCLC.
Updated data will be presented at ESMO.
Investor Conference Call and Webcast
InformationPrelude Therapeutics will host a conference
call, live webcast with slides and a Q&A on Friday, September
13, 2024 at 12:00 PM EST. A live webcast of the presentation will
be available at Events & Presentations - Prelude Therapeutics
(preludetx.com). A replay of the webcast will be available shortly
after the conclusion of the call and archived on the Company’s
website for 60 days following the call. The Company will be posting
its updated corporate presentation shortly after 10:00 AM EST on
its website at Events & Presentations - Prelude Therapeutics
(preludetx.com).
About Prelude
Therapeutics
Prelude Therapeutics is a leading precision oncology company
developing innovative medicines in areas of high unmet need for
cancer patients. Our pipeline is comprised of several novel drug
candidates including first-in-class, highly selective IV and oral
SMARCA2 degraders, and a potentially best-in-class CDK9 inhibitor.
We are also leveraging our expertise in targeted protein
degradation to discover, develop and commercialize next generation
degrader antibody conjugates (“Precision ADCs”) with partners. We
are on a mission to extend the promise of precision medicine to
every cancer patient in need. For more information, visit
preludetx.com.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the "safe harbor" provisions of
the Private Securities Litigation Reform Act of 1995, including,
but not limited to, anticipated discovery, preclinical and clinical
development activities for Prelude’s product candidates, the
potential safety, efficacy, benefits and addressable market for
Prelude’s product candidates, and clinical trial results for
Prelude’s product candidates. All statements other than statements
of historical fact are statements that could be deemed
forward-looking statements. The words “believes,” “anticipates,”
“estimates,” “plans,” “expects,” “intends,” “may,” “could,”
“should,” “potential,” “likely,” “projects,” “continue,” “will,”
“schedule,” and “would” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. These
forward-looking statements are predictions based on the Company’s
current expectations and projections about future events and
various assumptions. Although Prelude believes that the
expectations reflected in such forward-looking statements are
reasonable, Prelude cannot guarantee future events, results,
actions, levels of activity, performance or achievements, and the
timing and results of biotechnology development and potential
regulatory approval is inherently uncertain. Forward-looking
statements are subject to risks and uncertainties that may cause
Prelude's actual activities or results to differ significantly from
those expressed in any forward-looking statement, including risks
and uncertainties related to Prelude's ability to advance its
product candidates, the receipt and timing of potential regulatory
designations, approvals and commercialization of product
candidates, clinical trial sites and our ability to enroll eligible
patients, supply chain and manufacturing facilities, Prelude’s
ability to maintain and recognize the benefits of certain
designations received by product candidates, the timing and results
of preclinical and clinical trials, Prelude's ability to fund
development activities and achieve development goals, Prelude's
ability to protect intellectual property, and other risks and
uncertainties described under the heading "Risk Factors" in
Prelude’s Annual Report on Form 10-K for the year ended December
31, 2023, its Quarterly Reports on Form 10-Q and other documents
that Prelude files from time to time with the Securities and
Exchange Commission. These forward-looking statements speak only as
of the date of this press release, and Prelude undertakes no
obligation to revise or update any forward-looking statements to
reflect events or circumstances after the date hereof, except as
may be required by law.
Investor Contact: Robert A. Doody
Jr.Senior Vice President, Investor
Relations 484.639.7235rdoody@preludetx.com
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