-- 42.8% confirmed ORR observed in Claudin 18.2-enriched subset
of gastric and GEJ cancer --
-- EO-3021 demonstrated
differentiated safety profile, with minimal MMAE-associated
toxicities, including no neutropenia or peripheral
neuropathy/hypoesthesia --
-- Advancing
into dose expansion portion of Phase 1 trial; additional
monotherapy data expected in 1H 2025 --
-- Expect to
initiate dosing in combination portion of Phase 1 trial by year-end
2024 --
-- Elevation Oncology to host conference call and
webcast today at 8:30 a.m. ET
--
BOSTON, Aug. 6, 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 promising initial data from the dose escalation portion
of the ongoing Phase 1 clinical trial of EO-3021 in patients with
advanced, unresectable or metastatic solid tumors likely to express
Claudin 18.2, including gastric, gastroesophageal junction (GEJ),
pancreatic or esophageal cancers.
"Gastric and GEJ cancers are devastating diseases, which occur
frequently in the U.S. and globally and which, despite recent
advancements, still have high levels of mortality," 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. "There is
a particular need for highly selective therapies that benefit
patients with Claudin 18.2-expressing tumors. To that end, I am
excited by the initial data with EO-3021, which suggest it could
change the treatment paradigm for a significant portion of patients
with gastric or GEJ cancer. I am excited to evaluate EO-3021 in the
expansion portion of this Phase 1 clinical trial."
"We are pleased to share initial data from our Phase 1 clinical
trial of EO-3021," said Valerie Malyvanh Jansen, M.D., Ph.D.,
Chief Medical Officer of Elevation Oncology. "EO-3021 was designed
to maximize efficacy while minimizing the potential for free MMAE,
with the goal of offering patients an improved safety profile and
physicians a more readily combinable agent. We are encouraged to
see the benefits of EO-3021's site-specific conjugation translate
clinically, with minimal MMAE-associated toxicities observed in our
Phase 1 trial. Coupled with the promising anti-tumor activity
reported in patients with gastric or GEJ cancer, the data suggest
that EO-3021 is a potential best-in-class Claudin 18.2 antibody
drug conjugate. We look forward to advancing into monotherapy dose
expansion and initiating our combination cohorts in the months
ahead, as well as reporting additional data from our ongoing trial
in the first half of 2025."
Data from the Ongoing Phase 1 Clinical Trial
EO-3021 was evaluated in the dose escalation stage of a Phase 1
clinical trial in patients with advanced, unresectable or
metastatic solid tumors likely to express Claudin 18.2, including
gastric, GEJ, pancreatic or esophageal cancers. As of the data
cutoff date of June 10, 2024, 32
patients had been treated in the dose escalation portion of the
Phase 1 clinical trial at four dose levels (ranging from 1.0 mg/kg
to 2.9 mg/kg once every three weeks (Q3W), including 26 patients
with gastric or GEJ cancer. The median age was 65 years (ranging
from 45 to 83) and the median number of prior lines of therapy was
three (ranging from one to seven).
Initial Safety Data
As of the data cutoff of June 10,
2024, EO-3021 was observed to be generally well-tolerated.
No Grade 4 or 5 treatment-related adverse events were reported, and
less than 10% of patients discontinued EO-3021 due to adverse
events. Importantly, no neutropenia or peripheral
neuropathy/hypoesthesia, both known toxicities associated with
monomethyl auristatin E (MMAE), were observed in the safety
population of 32 patients treated with EO-3021.
Across all grades, the most common treatment-emergent adverse
events (reported in ≥20% of patients) were nausea (56%),
decreased appetite (47%), fatigue (41%) and diarrhea (28%). Four
dose-limiting toxicities (one each of Grade 3 fatigue,
encephalopathy, worsening decreased appetite, and Grade 2 decreased
appetite requiring a dose reduction at Cycle 2) were observed at
the 2.9 mg/kg dose level, leading to the decision to select the 2.0
mg/kg and 2.5 mg/kg Q3W doses for evaluation in the dose expansion
portion of the Phase 1 trial.
Initial Efficacy Data in Gastric and GEJ Cancer
As of the data cutoff date of June 10,
2024, 15 patients with gastric or GEJ cancers were evaluable
for efficacy with measurable disease, at least one post-baseline
scan, and available Claudin 18.2 IHC results. Seven of these 15
patients (47%) had tumors with Claudin 18.2 expression in ≥20% of
tumor cells at IHC 2+/3+. Claudin 18.2 expression was determined
retrospectively using a Claudin 18.2-specific IHC assay.
- In seven patients with Claudin 18.2 in ≥20% of tumor cells
at IHC 2+/3+, the objective response rate (ORR) was 42.8% (three confirmed partial
responses, one of which was confirmed following the June 10, 2024, data cutoff) and the disease
control rate (DCR) was 71.4%, including two patients with stable
disease (SD).
- In eight patients with Claudin 18.2 in <20% of tumor
cells at IHC 2+/3+, the ORR was 0%
and the DCR was 50%, including four patients with SD.
Clinical Development Plans for EO-3021
Elevation Oncology plans to initiate enrollment in the dose
expansion portion of the ongoing Phase 1 clinical trial, further
exploring two doses of EO-3021: 2.0 mg/kg IV Q3W and 2.5 mg/kg IV
Q3W. These doses were selected with the goal of further
characterizing EO-3021 in order to select an optimized dose for
further clinical development.
The primary objective of the study is to evaluate the safety,
tolerability and preliminary anti-tumor activity of EO-3021 in
patients with gastric or GEJ cancer, who have progressed on or
after standard therapy or who are intolerable of available standard
therapy. An exploratory objective of the study is to assess the
association of Claudin 18.2 expression and objective response.
Additionally, data from the dose escalation portion of Elevation
Oncology's Phase 1 trial suggest that a biomarker patient selection
strategy will be an important component of future clinical
development. Elevation Oncology is working to identify the
appropriate biomarker threshold and plans to introduce a biomarker
cutoff as part of the dose expansion portion of this Phase 1 trial.
Elevation Oncology expects to share additional data from the Phase
1 trial, including from the dose expansion cohort, in the first
half of 2025.
Additionally, Elevation Oncology plans to expand its ongoing
Phase 1 clinical trial to include combination cohorts evaluating
EO-3021 for the treatment of advanced or metastatic gastric or GEJ
cancer in the first- and second-line setting. As previously
disclosed, the combination cohorts 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 first-line setting. Elevation Oncology expects to
initiate dosing in the combination portion of the Phase 1 trial by
year-end 2024.
Conference Call Information
Elevation Oncology will host a live conference call and webcast
at 8:30 a.m. ET today to discuss the
initial safety and efficacy data announced today. Participants may
register for the conference call here. It is recommended that
participants join the call ten minutes prior to the scheduled
start.
A webcast of the call will also be available on the
Events page of Elevation Oncology's investor relations website
at https://investors.elevationoncology.com. The archived webcast
will be available on the website approximately two hours after the
conference call and will be available for 90 days following the
call.
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 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 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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