NEW YORK, Aug. 16, 2023 /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 first patient has been
dosed in the Phase 1 clinical trial evaluating 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.
"The dosing of the first patient is a major milestone in
evaluating EO-3021's potential benefit for these patients," said
Valerie Malyvanh Jansen, M.D.,
Ph.D., Chief Medical Officer of Elevation Oncology. "Claudin 18.2
has emerged as a promising therapeutic target in gastric cancer and
other solid tumors. Based on preclinical and early clinical data,
EO-3021 represents a potentially safer and more effective
therapeutic option for patients with advanced solid tumors that
likely express Claudin 18.2, including gastric and gastroesophageal
junction cancers. We look forward to evaluating the potential of
EO-3021 and expect to report preliminary data on safety and
anti-tumor activity from our Phase 1 study during the first half of
2025."
Meredith Pelster, M.D., MSCI,
Assistant Director of Gastrointestinal Research for Sarah Cannon
Research Institute and a principal investigator in the Phase 1
study of EO-3021, added, "Targeting Claudin 18.2 with an
antibody-drug conjugate represents a promising therapeutic option
for patients. The initial clinical data presented at the American
Society of Clinical Oncology 2023 Annual Meeting point to a safe
and tolerable therapy that can induce deep responses in patients
with gastric cancer. EO-3021 has the potential to provide a
much-needed treatment option for patients with advanced solid
tumors likely to express Claudin 18.2."
EO-3021 is a potential best-in-class antibody-drug conjugate
(ADC) that has been designed to selectively deliver a cytotoxic
payload directly to Claudin 18.2-expressing cancer cells to
minimize payload-associated toxicities and maximize anti-tumor
activity. EO-3021 is a fully human monoclonal antibody that targets
Claudin 18.2 and is site-specifically conjugated to the cytotoxic
agent monomethyl auristatin E via a cleavable linker, with a
drug-to-antibody ratio of 2.
Elevation Oncology's Phase 1 clinical trial (NCT05980416) is an
open-label, multi-center dose escalation and expansion study that
is expected to enroll up to approximately 120 patients to evaluate
the safety, tolerability, and preliminary anti-tumor activity of
EO-3021 in advanced solid tumors likely to express Claudin 18.2.
The dose escalation portion of the study will enroll patients with
advanced unresectable or metastatic solid tumors likely to express
Claudin 18.2, including gastric, gastroesophageal junction,
pancreatic or esophageal cancers. The expansion portion of the
study is expected to further evaluate EO-3021 in patients with
advanced unresectable or metastatic gastric or gastroesophageal
junction cancers. An additional objective of the study will be to
assess the association of Claudin 18.2 expression and objective
response. Elevation Oncology expects to report preliminary safety
and anti-tumor data from its Phase 1 study during the first half of
2025.
CSPC Pharmaceutical Group Limited (HKEX: 01093), is also
evaluating SYSA1801 (EO-3021) in an ongoing Phase 1 clinical trial
in China (NCT05009966).
Preliminary data from CSPC's Phase 1 study were presented at the
American Society of Clinical Oncology 2023 Annual Meeting. The
findings showed promising early signs of EO-3021 activity,
including an objective response rate of 47.1% in patients with
gastric cancer (8 PRs, including 4 confirmed PRs) and a disease
control rate of 64.7%, along with a well-tolerated safety profile
in patients with resistant/refractory tumors expressing Claudin
18.2. Elevation Oncology has licensed the exclusive rights to
develop and commercialize EO-3021 in all global territories outside
Greater China from CSPC.
About EO-3021
EO-3021 (also known as SYSA1801) is a differentiated,
clinical-stage antibody drug conjugate (ADC) comprised of an
immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets
Claudin 18.2 and 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 transformations, 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 in patients with
advanced, unresectable or metastatic solid tumors likely to express
Claudin 18.2 including gastric, gastroesophageal junction,
pancreatic or esophageal cancers.
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 molecular
target. EO-3021 selectively delivers a cytotoxic payload directly
to cancer cells expressing Claudin 18.2. Elevation Oncology is
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, pancreatic or esophageal
cancers. We are also exploring other opportunities through new or
existing partnerships and business development opportunities to
expand its novel 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, 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,"
"potential," "possible," "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, the impact of the continued
presence of COVID-19 on Elevation Oncology's business, 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