-- Treatment with both combination regimens
demonstrates synergistic anti-tumor activity, supporting planned
combination strategy for EO-3021 in patients with gastric or
gastroesophageal junction (GEJ) cancer –
-- On-track to initiate dosing in combination
portion of the ongoing Phase 1 clinical trial of EO-3021 in the
fourth quarter of 2024 --
BOSTON, Dec. 5, 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 new preclinical data demonstrating the combination
potential of EO-3021, a Claudin 18.2 antibody-drug conjugate (ADC),
with VEGFR2 or PD-1 inhibitors. The data will be presented in a
poster session at the European Society for Medical Oncology
Immuno-Oncology Annual Congress 2024 (ESMO-IO), being held
December 11-13, 2024, in Geneva, Switzerland.
"We are pleased to share preclinical data supporting our planned
evaluation of EO-3021 in combination with VEGFR2 or PD-1
inhibitors," said David Dornan,
Ph.D., Chief Scientific Officer of Elevation Oncology. "The data
demonstrate enhanced anti-tumor activity for both regimens,
highlighting the potential benefits of a combination approach. This
is particularly encouraging given our previously announced,
promising initial clinical data from our Phase 1 clinical trial of
single-agent EO-3021, which suggest EO-3021 potentially offers
competitive efficacy and differentiated safety profile, including
minimal payload-associated toxicity. We look forward to initiating
dosing in the combination portion of our ongoing Phase 1 clinical
trial of EO-3021 in the fourth quarter and unlocking the full
potential of EO-3021 as an active, more combinable Claudin 18.2
ADC."
In a poster titled, "Combination potential of EO-3021, a
CLDN18.2 vc-MMAE ADC, with VEGFR2 or PD-1 inhibition in preclinical
models of CLDN18.2-expressing cancers," Elevation Oncology will
present new in vivo data from preclinical studies evaluating
the anti-tumor activity of EO-3021 with a VEGFR2 or PD-1 inhibitor.
The data show:
- Treatment with EO-3021 and DC101, a surrogate of the VEGFR2
inhibitor ramucirumab, exhibited statistically superior tumor
growth inhibition (TGI) compared to treatment with either EO-3021
or DC101 alone (TGI: 88.2% for EO-3021 in combination with DC101,
compared to 20.1% for EO-3021 and 59.2% for DC101 alone).
- Treatment with EO-3021 and a PD-1 inhibitor exhibited
statistically superior TGI compared to treatment with either
EO-3021 or a PD-1 inhibitor alone (TGI: 79.9% for EO-3021 in
combination with a PD-1 inhibitor, compared to 33.8% for EO-3021
and 25.0% for a PD-1 inhibitor alone). 92% (11/12) of mice treated
with the combination of EO-3021 and a PD-1 inhibitor achieved a
complete response (CR), compared to 50% (6/12) mice treated with
EO-3021 monotherapy and 17% (2/12) mice treated with a PD-1
inhibitor alone.
Elevation Oncology expects to initiate dosing in the combination
portion of its ongoing Phase 1 clinical trial of EO-3021 in the
fourth quarter of 2024. Following clinical supply agreements with
Lilly and GSK, the combination cohorts will evaluate EO-3021 and
ramucirumab, a VEGFR2 inhibitor, in patients with gastric/GEJ
cancer in the second-line setting, and EO-3021 and dostarlimab, a
PD-1 inhibitor, in the front-line setting. Additionally, Elevation
Oncology continues to enroll patients in the monotherapy dose
expansion portion of its ongoing Phase 1 clinical trial and expects
to report additional monotherapy data in the first half of 2025. In
August 2024, Elevation Oncology
reported initial clinical data from the dose escalation portion of
the monotherapy study, demonstrating an objective response rate of
42.8% in patients with Claudin 18.2 in ≥20% of tumor cells at IHC
2+/3+, with differentiated safety profile, including minimal
hematological toxicity or hepatotoxicity, and no peripheral
neuropathy/hypoesthesia.
The ESMO-IO poster presentation will be available in the
"Publications" section of Elevation Oncology's website starting
December 12, 2024.
About EO-3021
EO-3021 is a differentiated, clinical-stage, potentially
best-in-class ADC 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 the dose expansion portion of a
Phase 1 trial (NCT05980416) in patients with advanced, unresectable
or metastatic gastric/GEJ adenocarcinoma that express Claudin 18.2.
Following recently signed clinical supply agreements with Lilly and
GSK, respectively, Elevation Oncology will evaluate EO-3021 in
combination with ramucirumab, a VEGFR2 inhibitor, in the
second-line setting and in combination with dostarlimab, a PD-1
inhibitor, in the front-line setting.
In September 2024, EO-3021 was granted Fast Track
designation by the FDA for the treatment of patients with advanced
or metastatic gastric/GEJ cancer expressing Claudin 18.2 that has
progressed on or after prior therapy. EO-3021 was granted
orphan drug designation by the FDA for the treatment of gastric
cancer (including cancer of gastroesophageal junction)
in November 2020 and for the treatment of pancreatic
cancer in May 2021.
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 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, Claudin 18.2 ADC and is
currently being evaluated in the dose expansion portion of a Phase
1 trial (NCT05980416) in patients with advanced, unresectable or
metastatic gastric/GEJ adenocarcinoma that express Claudin 18.2.
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 preclinical and clinical development
activities, expected timing of announcements of preclinical and
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
Gracie Tong
Senior Director, Investor Relations and Corporate
Communications
gtong@elevationoncology.com
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SOURCE Elevation Oncology
