-- Update from Ongoing Phase 1 Clinical Trial
of EO-3021 Now Expected Mid-2024 --
-- Expanding EO-3021
Clinical Development Program to Include Combination Strategy
--
-- Announcing HER3-targeting ADC as Second
Pipeline Program; Development Candidate Nomination in
2024--
-- Entering 2024 in Strong Financial Position,
with Cash into 2H 2025 --
BOSTON, Jan. 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 program updates and upcoming 2024 milestones.
"Our vision is to leverage our ADC and oncology drug development
expertise to deliver innovative, selective cancer therapies to
millions of patients with significant unmet needs. In 2023, we made
meaningful progress toward this goal, focusing our resources on
advancing EO-3021, our anti-Claudin 18.2 ADC therapy," said
Joseph Ferra, President and Chief
Executive Officer of Elevation Oncology. "As evidenced by initial
clinical data presented by our partner, we believe EO-3021
represents a highly differentiated, potentially best-in-class
molecule, able to deliver better tolerability and improved
anti-tumor activity to patients with tumors expressing varying
levels of Claudin 18.2. We look forward to sharing an update from
our ongoing trial in mid-2024."
Mr. Ferra continued, "We are also expanding our development
program to realize the full potential of anti-Claudin
18.2-targeting as a therapeutic approach. To expand on available
treatment options and optimize outcomes, particularly in the
gastric cancer setting, we plan to evaluate EO-3021 in combination
with both immunotherapy and targeted agents and will share details
on our planned Phase 1 combination study in the first half of 2024.
In addition, we are excited to reveal that our second program, an
ADC targeting HER3, continues to advance and we expect to nominate
a development candidate later this year."
Program Updates and Upcoming Milestones
EO-3021: Elevation Oncology is advancing EO-3021, a
differentiated antibody drug conjugate (ADC) for the treatment of
patients with advanced, unresectable or metastatic solid tumors
likely to express Claudin 18.2, including gastric, gastroesophageal
junction, pancreatic or esophageal cancers.
Single Agent:
- Elevation Oncology plans to provide an update from its ongoing
Phase 1 trial in mid-2024, with additional data expected in the
first half of 2025.
- In June 2023, Elevation
Oncology's partner, CSPC Pharmaceutical Group Limited, presented
initial clinical data for SYSA1801 (EO-3021) from their ongoing
Phase 1 dose escalation and expansion study in China. Initial data showed promising signs of
efficacy, including a 47.1% overall response rate (ORR) in patients
with resistant/refractory gastric cancer expressing Claudin 18.2,
with a well-tolerated safety profile.
- In August 2023, Elevation
Oncology began enrolling patients in an open-label, multi-center,
dose escalation and expansion Phase 1 clinical trial (NCT05980416),
designed to evaluate the safety, tolerability and preliminary
anti-tumor activity of EO-3021.
Combination:
- Elevation Oncology plans to expand its clinical development
program to evaluate EO-3021 in combination. The Company believes a
combination approach has the potential to offer optimal outcomes to
patients, particularly in the gastric cancer setting, and plans to
explore combination strategies with both immunotherapy and targeted
agents. Elevation Oncology expects to share details on its planned
Phase 1 combination study in the first half of 2024.
HER3-ADC: Elevation Oncology's second program is a
differentiated HER3-targeting ADC. HER3 is a well-validated ADC
target, which is overexpressed across solid tumors and often
associated with poor outcomes. There are currently no HER3-targeted
ADC agents approved for the treatment of cancer.
- Elevation Oncology is currently evaluating its HER3-ADC program
and plans to nominate a development candidate in 2024.
Financial Guidance
Elevation Oncology expects that its cash, cash equivalents and
marketable securities as of September 30,
2023, will be sufficient to fund its current operations into
the second 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
transformations, 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.
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 evaluating EO-3021
in a Phase 1 study in patients with advanced, unresectable or
metastatic solid tumors likely to express Claudin 18.2 including
gastric, gastroesophageal, pancreatic or esophageal cancers. We are
also exploring other opportunities through new or existing
partnerships and business development opportunities to expand our
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 clinical and preclinical development
activities, expected timing of announcements of clinical results
and trial details, potential benefits of Elevation Oncology's
product candidates, potential market opportunities for Elevation
Oncology's product candidates, the ability of Elevation Oncology's
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
Candice Masse, 978-879-7273
Senior Director, Corporate Communications & Investor
Relations
cmasse@elevationoncology.com
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SOURCE Elevation Oncology