-- EO-1022 is comprised of seribantumab, an
anti-HER3 monoclonal antibody, and an MMAE payload –
-- Following recently signed global license
agreement with Synaffix, EO-1022 leverages the company's
GlycoConnect® and HydraSpace® ADC technologies for glycan
site-specific conjugation and SYNstatin E™ linker-payload
--
– Elevation Oncology expects to present
EO-1022 preclinical data in 1H 2025 and to file an IND application
in 2026 –
BOSTON, Dec. 12,
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 the nomination of EO-1022 as its
HER3 ADC development candidate. EO-1022 is currently progressing
through preclinical development, and Elevation Oncology expects to
file an investigational new drug (IND) application in 2026.
HER3 is a protein expressed across several types of solid
tumors, including breast cancer, EGFR-mutant non-small cell lung
cancer and pancreatic cancer, and often associated with poor
clinical outcomes. EO-1022 is a differentiated ADC containing
seribantumab, an anti-HER3 monoclonal antibody (mAb), and a
monomethyl auristatin E (MMAE) payload, with site-specific
conjugation to the glycan. EO-1022 is being developed for the
treatment of patients living with solid tumors that express
HER3.
"The nomination of our HER3-ADC development candidate marks a
key milestone for Elevation Oncology in bolstering our ADC
pipeline. EO-1022 combines the seribantumab antibody and state-of
the-art ADC site-specific technology. We believe seribantumab is
ideally-suited to be used in an ADC due to its selectivity in
delivering cytotoxic payload to HER3-expressing cancer cells and
its well-tolerated safety profile demonstrated in over 900 patients
in multiple studies," said Joseph
Ferra, President and Chief Executive Officer of Elevation
Oncology. "This program is another step forward in leveraging our
ADC and oncology drug development expertise to develop innovative,
selective cancer therapies that address significant unmet needs. We
look forward to sharing preclinical data for EO-1022 in the first
half of 2025, as we continue to advance this asset toward the
clinic."
Also today, Elevation Oncology announced that it has entered
into a licensing agreement with Synaffix B.V. (Synaffix). This
licensing agreement gives Elevation Oncology global access to
Synaffix's clinical stage, site-specific ADC technology platform,
including GlycoConnect® antibody conjugation technology,
HydraSpace® polar spacer technology, as well as the toxSYN®
linker-payload, SYNstatin E™. The license granted to GlycoConnect®
and HydraSpace® technologies is exclusive to HER3 as a single
target in combination with SYNstatin E® linker-payload.
"HER3 is broadly expressed in various cancer types, making it a
compelling target for innovative therapeutic strategies. We believe
an ADC approach is uniquely positioned to fully unlock the clinical
potential of HER3," said David
Dornan, Ph.D., Chief Scientific Officer of Elevation
Oncology. "We are excited to nominate EO-1022, which leverages
Synaffix's state-of-the art site-specific conjugation and
differentiated linker-payload for a potentially best-in-class
profile. We look forward to advancing our pipeline, as we work
towards transforming the care and treatment of patients living with
solid tumors that overexpress HER3."
"As a dedicated partner in the ADC space, Synaffix is excited to
collaborate with Elevation Oncology to push the boundary of ADC
innovation," said Peter van de
Sande, Head of Synaffix. "With our state-of-the-art ADC
technology platform and established supply chain, Elevation is
well-positioned to accelerate the development of its differentiated
HER3 ADC."
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/gastroesophageal adenocarcinoma that express
Claudin 18.2. We are also advancing EO-1022, a HER3-targeting ADC
for the treatment of patients living with solid tumors that express
HER3, through preclinical development. For more information, visit
www.ElevationOncology.com.
About Synaffix
Synaffix B.V. is a biotechnology company that enables ADC
product candidates using its clinical-stage, site-specific ADC
technology platform based on GlycoConnect®, HydraSpace® and toxSYN®
technologies, that together enable any company with an antibody to
develop proprietary best-in-class ADC products under a single
license from Synaffix.
The Synaffix platform enables a rapid timeline to clinic due to
the established supply chain of technology components.
Synaffix holds granted patents to its technology. The
business model of Synaffix is target-specific technology
out-licensing, as exemplified through its existing deals with ADC
Therapeutics, Mersana Therapeutics, Shanghai Miracogen (acquired by
Lepu Biopharma), Innovent Biologics, Kyowa Kirin, Genmab,
Macrogenics, Amgen, Hummingbird Biosciences, Chong Kun Dang Pharma,
ABL Bio, SOTIO Biotech, Kivu Bioscience, BigHat Biosciences,
Illumina and Elevation Oncology.
Synaffix was fully acquired by Lonza (SIX:LONN) in June 2023.
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 development activities,
expected timing of announcements of preclinical 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