EO-3021 demonstrated anti-tumor activity in
preclinical models expressing varying levels of Claudin
18.2
EO-3021 induced a confirmed partial response
in a patient with metastatic gastric cancer
Company is on track to initiate a Phase 1
clinical trial in the US in the second half of 2023
NEW
YORK, April 17, 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 is
presenting preclinical proof-of-concept data and highlighting a
clinical case study in Claudin 18.2-expressing cancers for the
company's lead candidate, EO-3021. The data are being featured in
an oral presentation as part of the New Drugs on the Horizon
special session at the American Association for Cancer Research
(AACR) Annual Meeting 2023, being held April
14-19, 2023, in Orlando,
Florida.
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 toxicities and maximize anti-tumor activity. EO-3021 is a
fully human monoclonal antibody (mAb) that targets Claudin 18.2 and
is site-specifically conjugated to the cytotoxic agent monomethyl
auristatin E (MMAE), via a cleavable linker with a drug-to-antibody
ratio (DAR) of 2.
"This is the first time that preclinical data are being
presented for EO-3021, supporting its potential to effectively
target cancer cells expressing Claudin 18.2," said David Dornan, Ph.D., Chief Scientific Officer of
Elevation Oncology. "We are also very encouraged by the results of
the clinical case study involving a patient with metastatic gastric
cancer who achieved a confirmed partial response on treatment with
EO-3021 in an ongoing Phase 1 clinical trial being conducted in
China by our partner, CSPC
Pharmaceutical Group Limited. We look forward to initiating a Phase
1 clinical trial of EO-3021 in the US in the second half of
2023."
Key Findings
- EO-3021 is an ADC comprised of a fully human immunoglobulin G1
(IgG1) mAb that targets Claudin 18.2 and is site-specifically
conjugated to the MMAE payload via a cleavable linker with a DAR of
2.
- EO-3021 retains antibody-dependent cell-mediated cytotoxicity
(ADCC) and complement dependent cytotoxicity (CDC).
- EO-3021 reduction in cell viability requires Claudin 18.2
expression in vitro with no effects seen on Claudin
18.2-negative cells.
- EO-3021 demonstrated anti-tumor activity in preclinical
xenograft models of pancreatic and gastric cancers expressing
varying levels of Claudin 18.2.
-
- A single dose of EO-3021 demonstrated tumor regression across
low, medium, and high Claudin 18.2-expressing models, with a lower
minimal efficacious dose in models with medium and high levels of
Claudin 18.2 relative to models with low levels of Claudin
18.2.
- EO-3021 outperformed standard of care chemotherapy in gastric
and pancreatic cancer preclinical xenograft models.
- A patient with metastatic gastric cancer in an ongoing Phase 1
clinical trial of SYSA1801 (EO-3021) in China (NCT05009966) conducted by CSPC
Pharmaceutical Group Limited (HKEX: 01093) was also
highlighted.
-
- Patient was treated with dose level 2, or 1.0 mg/kg EO-3021,
intravenously, every three weeks for 12 cycles (treatment
ongoing).
- The best overall response, as evaluated per RECIST v1.1, was a
confirmed partial response (66.7% maximal tumor reduction).
- Duration of response was approximately 11 months and
ongoing.
The full presentation can be accessed under the resources and
publications page of the Elevation Oncology website following the
completion of the live presentation at AACR.
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 only expressed in gastric epithelial
cells. During malignant transformation in many solid tumors, the
tight junctions may become disrupted, exposing Claudin 18.2 and
allowing them to be accessible by Claudin 18.2 targeting agents. An
Investigational New Drug application for EO-3021 has been cleared
by the U.S. Food and Drug Administration.
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. We are working to rapidly
advance EO-3021 into the clinic in the US across a range of solid
tumor indications, as well as exploring other opportunities through
new or existing partnerships and business development opportunities
to expand our 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 preclinical and 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," "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 COVID-19
pandemic 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