-- Plan to evaluate EO-3021 in combination
with ramucirumab and dostarlimab; entered into clinical supply
agreements with Lilly and GSK, respectively --
-- Expect to initiate dosing in combination
portion of the Phase 1 trial by year-end 2024 --
-- Combination cohorts broaden market
opportunity for EO-3021 to address unmet needs across second- and
first-line gastric or gastroesophageal junction cancer settings
--
-- On-track to provide update from ongoing
Phase 1 clinical trial evaluating monotherapy EO-3021 by mid-3Q
2024, with additional data in 1H 2025 --
BOSTON, June 27,
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 plans to expand its ongoing Phase 1
clinical trial to include two combination cohorts evaluating
EO-3021 for the treatment of advanced gastric or gastroesophageal
junction cancer. Following recently signed clinical supply
agreements with Eli Lilly and Company (Lilly) and GSK,
respectively, Elevation Oncology will evaluate EO-3021 in
combination with ramucirumab, a VEGFR2 inhibitor, in second-line
patients and in combination with dostarlimab, a PD-1 inhibitor, in
the front-line setting. The Company expects to initiate dosing in
the combination portion of the Phase 1 trial by year-end 2024.
"EO-3021 has the potential to change the treatment paradigm for
tumors that express Claudin 18.2, including a majority of gastric
and gastroesophageal junction adenocarcinomas," said Valerie
Malyvanh Jansen, M.D., Ph.D., Chief Medical Officer of
Elevation Oncology. "Based on safety data from preclinical and
clinical trials, we believe EO-3021 benefits from a differentiated
safety profile and will be readily combinable. We also know that
combination-based regimens are a mainstay of cancer care, and that
the combination of two therapies with distinct mechanisms of action
often enables patients to achieve deeper, more durable responses.
As such, we are excited to begin evaluating EO-3021 together with
ramucirumab, a VEGFR2 inhibitor, and with dostarlimab, a PD-1
inhibitor, in the second- and first-line settings, respectively. In
parallel, we continue to advance our Phase 1 trial of EO-3021
monotherapy toward initial safety and efficacy data by mid-third
quarter."
Clinical Development Plans for EO-3021 in Combination
EO-3021 is a differentiated, potential best-in-class antibody
drug conjugate (ADC) targeting Claudin 18.2. EO-3021 was designed
with site-specific conjugation at glutamine (Q295), with the goal
of increasing the stability of the linker-payload and minimizing
the potential for free monomethyl auristatin E (MMAE) compared to
traditional cysteine-based conjugation. In preclinical studies and
the Phase 1 clinical trial conducted by Elevation Oncology's
partner, data showed a favorable tolerability profile, with limited
MMAE-related toxicities.
Initial development of EO-3021 in combination will explore two
regimens for the treatment of gastric or gastroesophageal junction
cancer:
- EO-3021 in combination with ramucirumab in second-line
patients: Ramucirumab is a monoclonal antibody that targets
VEGFR2 and is approved for use in combination with paclitaxel for
the treatment of second-line gastric or gastroesophageal junction
cancer with disease progression on or after prior fluoropyrimidine-
or platinum-containing chemotherapy. With EO-3021, Elevation
Oncology aims to introduce a combination agent that, when paired
with ramucirumab, can potentially deliver improved safety and
efficacy as compared to the approved combination of ramucirumab and
paclitaxel.
- EO-3021 in combination with dostarlimab in front-line
patients: Dostarlimab is approved alone and in combination with
chemotherapy for certain types of dMMR and MSI-H endometrial cancer
in the US; it also has an accelerated approval in certain dMMR
solid tumors. By combining EO-3021 and an immune checkpoint
inhibitor, Elevation Oncology aims to deliver synergistic benefit,
potentially offering patients improved outcomes beyond those seen
with existing immunotherapy regimens for gastric or
gastroesophageal junction cancer in the front-line setting.
Each combination cohort will include a dose escalation and
expansion portion, evaluating the combination of EO-3021 and
ramucirumab or EO-3021 and dostarlimab. The primary endpoints will
include safety and anti-tumor activity. Elevation Oncology plans to
initiate dosing in the combination portion of the Phase 1 trial by
year-end 2024.
In June 2024, Elevation Oncology
entered into clinical supply agreements with Lilly and GSK to
supply their respective compounds for these combination cohorts.
Elevation Oncology will sponsor and conduct all clinical
development of both combinations and will assume all costs
associated with the study. All companies will retain commercial
rights to their respective compounds.
Elevation Oncology continues to enroll patients in the
monotherapy cohort of its ongoing Phase 1 clinical trial
(NCT05980416) and remains on track to share initial safety and
efficacy data by mid-third quarter 2024, with additional data 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 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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SOURCE Elevation Oncology