-- On track to provide update from ongoing
Phase 1 clinical trial in mid-2024; additional data expected in 1H
2025 --
BOSTON, Feb. 22,
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 it has expanded its ongoing
Phase 1 clinical trial of EO-3021 outside the United States, dosing the first patient in
Japan. This trial is evaluating
the safety, tolerability and preliminary anti-tumor activity of
EO-3021 in patients with advanced, unresectable or metastatic solid
tumors likely to express Claudin 18.2, including gastric,
gastroesophageal junction, pancreatic or esophageal cancers.
"We are pleased to expand our clinical development efforts
outside of the United States and
into Japan where there is a large
number of patients with gastric cancer who could benefit from
EO-3021," said Valerie Malyvanh
Jansen, M.D., Ph.D., Chief Medical Officer of Elevation
Oncology. "Claudin 18.2 is expressed in most gastric
adenocarcinomas and is increasingly recognized as an important
therapeutic target, which can be effectively addressed with an
antibody drug conjugate (ADC). We are excited to have dosed our
first patient in Japan, as we
continue to execute on our mission of delivering novel, selective
cancer therapies that can offer better outcomes to patients."
"Despite recent advancements in the treatment of gastric cancer
and improvements in mortality, there remains a significant need for
new treatment options that offer patients improved outcomes," said
Kohei Shitara, M.D., Chief,
Department of Gastrointestinal Oncology, National Cancer Center
Hospital East in Kashiwa, Japan
and principal investigator on the Phase 1 clinical trial, "Based on
preclinical and early clinical data, I believe EO-3021 has the
potential to overcome the limitations of other therapeutic
modalities to deliver benefit to patients with varying levels of
Claudin 18.2 expression. I am excited to dose patients with EO-3021
and to have access to this much-needed option for patients in
Japan."
Elevation Oncology's Phase 1 clinical trial (NCT05980416) is an
open-label, multi-center dose escalation and expansion study to
evaluate the safety, tolerability and preliminary anti-tumor
activity of EO-3021. An additional objective of the study
will be to assess the association of Claudin 18.2 expression and
objective response. The study is recruiting patients with advanced
unresectable or metastatic solid tumors likely to express Claudin
18.2, including gastric, gastroesophageal junction, pancreatic or
esophageal cancers, at multiple sites in the United States and Japan. Elevation Oncology expects to provide
an update from the trial in mid-2024, with additional data expected
in the first half of 2025.
About EO-3021
EO-3021 (also known as SYSA1801) 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. EO-3021 is
site-specifically conjugated to the monomethyl auristatin E (MMAE)
payload via a cleavable linker with 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 study (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 rethinking drug development by seeking
out innovative, selective cancer therapies that can be matched to a
patient's unique tumor characteristics. Our lead candidate,
EO-3021, is a potential best-in-class antibody drug conjugate (ADC)
designed to target Claudin 18.2, a clinically validated oncology
target. EO-3021 selectively delivers a cytotoxic payload directly
to cancer cells expressing Claudin 18.2. We are evaluating EO-3021
in a Phase 1 study in patients with advanced, unresectable or
metastatic solid tumors likely to express Claudin 18.2 including
gastric, gastroesophageal junction, pancreatic or esophageal
cancers. We are also exploring other opportunities through new or
existing partnerships and business development opportunities to
expand our oncology pipeline. 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 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
Candice Masse,
978-879-7273
Senior Director, Corporate Communications & Investor
Relations
cmasse@elevationoncology.com
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SOURCE Elevation Oncology