BOSTON, Sept. 23,
2024 /PRNewswire/ -- Elevation Oncology, Inc.
(Nasdaq: ELEV), an innovative oncology company focused on the
discovery and development of selective cancer therapies to treat
patients across a range of solid tumors with significant unmet
medical needs, today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation (FTD) to
EO-3021, a differentiated antibody drug conjugate (ADC), for the
treatment of patients with advanced or metastatic gastric and
gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2
that has progressed on or after prior therapy.
"We are delighted to receive Fast Track designation for EO-3021,
which marks an encouraging recognition of the unmet medical need in
patients with Claudin 18.2-expressing tumors, as well as the
potential for EO-3021 to deliver improved therapeutic outcomes,"
said Joseph Ferra, President and
Chief Executive Officer of Elevation Oncology. "This designation is
based on nonclinical and initial clinical data from our ongoing
Phase 1 clinical trial. As we announced in August, early results
showed a confirmed overall response rate of 42.8% in a Claudin
18.2-enriched subset of gastric and GEJ cancer. In addition, we
observed differentiated tolerability, with minimal MMAE-associated
toxicities, including no neutropenia or peripheral
neuropathy/hypoesthesia. We are grateful for the opportunity to
potentially expedite the delivery of EO-3021 and look forward to
advancing through monotherapy dose expansion and reporting
additional data from our ongoing trial in the first half of 2025,
and to initiating the combination portion of our study later this
year."
Fast Track is a process designed by the FDA to facilitate the
development and expedite the review of therapeutic candidates
intended to treat serious or life-threatening conditions, for which
nonclinical or clinical data demonstrate the potential to address
unmet medical needs. Therapeutic candidates that receive FTD may be
eligible for more frequent interactions with the FDA to discuss the
candidate's development plan. Therapeutic candidates with Fast
Track designation may also be eligible for priority review and
accelerated approval if supported by clinical data.
About EO-3021
EO-3021 is a differentiated, clinical-stage antibody drug
conjugate (ADC) with best-in-class potential comprised of an
immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets
Claudin 18.2 and a monomethyl auristatin E (MMAE) payload with
a cleavable linker that is site-specifically conjugated to
Glutamine 295 providing a drug-to-antibody ratio (DAR) of 2.
Claudin 18.2 is a specific isoform of Claudin 18 that is normally
expressed in gastric epithelial cells. During malignant
transformation, the tight junctions may become disrupted, exposing
Claudin 18.2 and allowing them to be accessible by Claudin 18.2
targeting agents. Elevation Oncology is evaluating EO-3021 in a
Phase 1 trial (NCT05980416) in patients with advanced, unresectable
or metastatic solid tumors likely to express Claudin 18.2 including
gastric, gastroesophageal junction, pancreatic or esophageal
cancers.
Elevation Oncology has the exclusive rights to develop and
commercialize EO-3021 in all global territories outside
Greater China.
About Elevation Oncology, Inc.
Elevation Oncology is an innovative oncology company focused on
the discovery and development of selective cancer therapies to
treat patients across a range of solid tumors with significant
unmet medical needs. We are leveraging our antibody-drug conjugate
(ADC) expertise to advance a novel pipeline, initially targeting
two clinically validated targets in oncology, Claudin 18.2 and
HER3. Our lead candidate, EO-3021, is a potential best-in-class ADC
designed to target Claudin 18.2 and is currently being evaluated in
a Phase 1 trial (NCT05980416) in patients with advanced,
unresectable or metastatic solid tumors likely to express Claudin
18.2 including gastric, gastroesophageal junction, pancreatic or
esophageal cancers. Additionally, we expect to nominate a
development candidate for our second program, a HER3-targeting ADC
for the treatment of patients with solid tumors that overexpress
HER3, in 2024. For more information, visit
www.ElevationOncology.com.
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 clinical and preclinical development
activities, expected timing of announcements of clinical results,
potential benefits of Elevation Oncology's product candidates,
potential market opportunities for Elevation Oncology's product
candidates and the ability of Elevation Oncology's product
candidates to treat their targeted indications. All statements
other than statements of historical fact are statements that could
be deemed forward-looking statements. These forward-looking
statements may be accompanied by such words as "aim," "anticipate,"
"believe," "could," "estimate," "expect," "forecast," "goal,"
"intend," "may," "might," "plan," "possible," "potential," "will,"
"would," and other words and terms of similar meaning. Although
Elevation Oncology believes that the expectations reflected in such
forward-looking statements are reasonable, Elevation Oncology
cannot guarantee future events, results, actions, levels of
activity, performance or achievements, and the timing and results
of biotechnology development and potential regulatory approval are
inherently uncertain. Forward-looking statements are subject to
risks and uncertainties that may cause Elevation Oncology's actual
activities or results to differ significantly from those expressed
in any forward-looking statement, including risks and uncertainties
related to Elevation Oncology's ability to advance its product
candidates, the timing and results of preclinical studies and
clinical trials, approvals and commercialization of product
candidates, the receipt and timing of potential regulatory
designations, Elevation Oncology's ability to fund development
activities and achieve development goals, Elevation Oncology's
ability to protect intellectual property, Elevation Oncology's
ability to establish and maintain collaborations with third
parties, and other risks and uncertainties described under the
heading "Risk Factors" in documents Elevation Oncology 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 Elevation Oncology undertakes no obligation to revise
or update any forward-looking statements to reflect events or
circumstances after the date hereof.
Elevation Oncology Investor and Media Contact
Hannah Deresiewicz,
212-362-1200
EVP, Managing Director, Precision AQ
hannah.deresiewicz@precisionaq.com
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SOURCE Elevation Oncology