-- Initiated dosing in Phase 1
clinical trial cohort evaluating Claudin 18.2 ADC EO-3021 in
combination with ramucirumab or dostarlimab in patients with
advanced gastric/gastroesophageal junction (GEJ) cancer
--
-- Expect to report initial data from
combination cohort in 4Q 2025 or 1Q 2026 --
-- On-track
to report additional monotherapy data from dose escalation and
expansion cohorts of ongoing Phase 1 clinical trial in 1H 2025
--
-- Plan to present preclinical data for HER3 ADC
EO-1022 in 1H 2025 and file an Investigational New Drug (IND)
application in 2026 --
BOSTON, Jan. 13,
2025 /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 program updates and upcoming
milestones.
"We are rapidly advancing EO-3021 to address significant unmet
needs in treating earlier lines of advanced gastric/GEJ cancer,
where we believe we have a unique ability to improve on the
standard of care," said Joseph
Ferra, President and Chief Executive Officer of Elevation
Oncology. "As we enter 2025, we are honing our focus, leveraging
the competitive anti-tumor activity and differentiated safety
profile of EO-3021 to explore combination approaches in the first-
and second-line settings. With our Phase 1 clinical trial ongoing
and now enrolling both monotherapy and combination cohorts, we are
in a leading position to explore the compelling potential of
EO-3021, our differentiated Claudin 18.2 ADC, to improve outcomes
for people living with advanced gastric/GEJ cancer."
Mr. Ferra continued, "We look forward to sharing additional data
from our Phase 1 dose escalation and expansion study of EO-3021 in
the first half of 2025. With this readout, we aim to build on the
promising initial data reported in August
2024, reinforcing EO-3021's robust anti-tumor activity and
potential better combinability, while garnering additional insights
to inform our go-forward clinical development efforts. We are
enthusiastic about the potential of EO-3021 in addressing
meaningful market opportunities and look forward to a
transformative 2025."
Program Updates and Upcoming Milestones
EO-3021: Elevation Oncology is developing EO-3021, a
differentiated, potentially best-in-class antibody drug conjugate
(ADC) for the treatment of patients with advanced, unresectable or
metastatic solid tumors likely to express Claudin 18.2, including
gastric/GEJ cancer.
In August 2024, Elevation Oncology
reported promising initial monotherapy data from the dose
escalation portion of its ongoing Phase 1 clinical trial of
EO-3021, demonstrating competitive efficacy, with a 42.8% confirmed
overall response rate (ORR) in a biomarker-enriched population, and
a differentiated safety profile, including minimal hematological
toxicity and hepatotoxicity, and no peripheral
neuropathy/hypoesthesia.
Based on these data, Elevation Oncology is focusing the clinical
development of EO-3021 on the first- and second-line treatment of
advanced gastric/GEJ cancer, where EO-3021's key attributes can
potentially provide differentiated benefits and address unmet needs
in both patient outcomes and safety.
Monotherapy:
The dose expansion portion of Elevation Oncology's Phase 1
clinical trial of monotherapy EO-3021 is ongoing. As of
January 2025, Elevation Oncology has
implemented prospective Claudin 18.2 expression testing as part of
the patient screening process, focusing enrollment on patients with
≥25% of tumor cells at IHC 1+/2+/3+. Elevation Oncology expects to
report additional safety and efficacy data from the dose escalation
and expansion portions of the study in the first half of 2025.
Combination:
Patient dosing is ongoing in the combination portion of
Elevation Oncology's Phase 1 clinical trial of EO-3021. The
combination cohorts are evaluating EO-3021 in combination with
dostarlimab, a PD-1 inhibitor, in the first line setting and with
ramucirumab, a VEGFR2 inhibitor, in the second line setting.
By combining EO-3021 and dostarlimab, an immune checkpoint
inhibitor, Elevation Oncology aims to deliver synergistic benefit,
potentially offering patients improved outcomes beyond those seen
with the existing combination of immunotherapy and chemotherapy.
The combination of an immunotherapy and chemotherapy agent is the
standard of care for the treatment of gastric/GEJ cancer in the
front-line setting.
With the EO-3021 and ramucirumab combination, Elevation Oncology
aims to deliver improved tolerability and synergistic anti-tumor
activity compared to the approved combination of ramucirumab and
paclitaxel. The combination of ramucirumab and paclitaxel is the
standard of care for the treatment of second-line gastric/GEJ
cancer.
Elevation Oncology expects to report initial data from the
combination cohorts in the fourth quarter of 2025 or the first
quarter of 2026.
EO-1022: Elevation Oncology is developing EO-1022, a
differentiated HER3 ADC for the treatment of patients with
HER3-expressing solid tumors, including breast cancer, EGFR-mutant
non-small cell lung cancer, and pancreatic cancer. EO-1022 combines
seribantumab, a fully human anti-HER3 monoclonal antibody, and a
monomethyl auristatin E (MMAE) payload with site-specific
conjugation to glycan. It is designed to leverage seribantumab's
desirable internalization capability and the latest site-specific
ADC technology to deliver a safe, effective option for patients
living with solid tumors that express HER3.
Elevation Oncology expects to present preclinical data for
EO-1022 in the first half of 2025 and to file an IND application in
2026.
Financial Guidance
Elevation Oncology expects that its cash, cash equivalents and
marketable securities as of September 30,
2024, will be sufficient to fund its current operations into
2026.
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 a Phase 1 trial (NCT05980416) as a
monotherapy, and in combinations with dostarlimab or ramucirumab,
in patients with advanced, unresectable or metastatic
gastric/gastroesophageal adenocarcinoma that express Claudin 18.2.
We are also advancing EO-1022, a HER3 ADC for the treatment of
patients living with solid tumors that express HER3, through
preclinical development. 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 and preclinical development
activities, expected timing of announcements of clinical and
preclinical results, potential benefits of product candidates,
potential market opportunities for product candidates, the ability
of product candidates to treat their targeted indications and
Elevation Oncology's expectations about its cash runway. 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
