Initial data showed promising signs of
efficacy, including a 47.1% ORR in patients with
resistant/refractory gastric cancer expressing Claudin 18.2, with a
well-tolerated safety profile
Elevation Oncology on track to initiate Phase
1 clinical trial in the US in the second half of 2023
NEW
YORK, June 3, 2023 /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, together with CSPC Pharmaceutical
Group Limited (CSPC; HKEX: 01093), today announced promising
initial clinical data for SYSA1801 (EO-3021) from the ongoing Phase
1 dose escalation and expansion study in China. These data will be presented at the
American Society of Clinical Oncology (ASCO) 2023 Annual Meeting,
being held June 2-6, 2023, in
Chicago, IL.
EO-3021 is a potential best-in-class antibody-drug conjugate
(ADC) that has been designed to selectively deliver a cytotoxic
payload directly to Claudin 18.2-expressing cancer cells to
minimize toxicities and maximize anti-tumor activity. EO-3021 is a
fully human monoclonal antibody (mAb) that targets Claudin 18.2 and
is site-specifically conjugated to the cytotoxic agent monomethyl
auristatin E (MMAE), via a cleavable linker with a drug-to-antibody
ratio (DAR) of 2. Elevation Oncology's partner, CSPC, is actively
recruiting patients in the Phase 1 clinical trial of SYSA1801
(EO-3021) in China
(NCT05009966).
"In these preliminary Phase 1 data, EO-3021 demonstrated an
objective response rate of 47% in patients with
resistant/refractory gastric cancer expressing Claudin 18.2, with a
well-tolerated safety profile in a heavily pretreated patient
population," said Valerie Malyvanh
Jansen, M.D., Ph.D., Chief Medical Officer of Elevation
Oncology. "While the study remains ongoing, the responses seen are
particularly impressive, especially in the gastric cancer setting
in tumors expressing Claudin 18.2. These results are highly
informative as Elevation Oncology prepares to initiate a Phase 1
clinical trial of EO-3021 in the US in the second half of
2023."
"We are highly encouraged by these Phase 1 study data which
demonstrate that SYSA1801 (EO-3021) is an active drug that has a
well-tolerated safety profile in patients with difficult to treat
cancers," said Chunlei Li, Ph.D.,
Chief Scientific Officer of CSPC Pharmaceutical Group Limited.
"These data support the potential of this unique product candidate
for patients with Claudin 18.2-expressing cancers."
Key Findings from the Phase 1 Study
- As of the data cutoff date of November
5, 2022, 33 patients with resistant/refractory solid tumors
that expressed Claudin 18.2 were enrolled
- Patients received 0.5 mg/kg to 3 mg/kg of SYSA1801 (EO-3021)
administered intravenously (IV) every 3 weeks (Q3W) as part of the
dose escalation (n=17) portion of the study; in the dose expansion
portion of the study, patients (n=16) were treated at effective
doses (2.0 mg/kg IV Q3W and 2.5 mg/kg IV Q3W)
-
- 26 patients (78.8%) had gastric cancer (GC); 7 patients (21.2%)
had pancreatic cancer
- 11 patients (33.3%) had been pretreated with ≥3 prior lines of
therapy
- 21 patients (gastric cancer n=17; pancreatic cancer n=4) were
evaluable for efficacy per RECIST v1.1
-
- In gastric cancer, the objective response rate (ORR) was 47.1%
(8 PRs, including 4 confirmed PRs) and the disease control rate
(DCR) was 64.7%, including three patients with stable disease
(SD)
- The overall ORR was 38.1% (8 PRs, including 4 confirmed PRs)
and DCR was 57.1% (including 4 SDs)
- Of the 33 patients enrolled at the time of data cutoff,
treatment-related adverse events (TRAEs) of any grade occurred in
25 patients (75.8%), including eight (24.2%) TRAEs of ≥Grade 3
-
- The most common TRAEs (occurring in >20% of patients) were
nausea (42.4%), vomiting (36.4%), dry eye syndrome (21.2%) and
anemia (21.2%)
- Two dose-limiting toxicities (DLTs) of Grade 3 nausea and
vomiting occurred at the 3 mg/kg IV Q3W dose
- No treatment-related deaths were reported
- The dose escalation and expansion portion of the study in
China is ongoing
Details for the ASCO 2023 Presentation are as
Follows:
Title: First-in-human dose escalation and expansion study
of SYSA1801, an antibody-drug conjugate targeting claudin 18.2 in
patients with resistant/refractory solid tumors.
Presenter: Dr. Yakun Wang
Session Type: Poster Discussion Session
Session Title: Molecularly Targeted Agents and Tumor
Biology
Poster Session Date and Time: Saturday, June 3, 2023, 8:00 a.m. – 11:00 a.m.
CT
Poster Discussion Date and Time: Saturday, June 3, 2023, at 1:15 p.m. CT
Abstract Number: 3016
Poster Number: 214
The full presentation can be accessed under the resources and
publications page of the Elevation Oncology website following the
completion of the presentation session at ASCO.
About EO-3021
EO-3021 (also known as SYSA1801) is a differentiated,
clinical-stage antibody drug conjugate (ADC) comprised of an
immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets
Claudin 18.2 and 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 in many solid
tumors, the tight junctions may become disrupted, exposing Claudin
18.2 and allowing them to be accessible by Claudin 18.2 targeting
agents. An Investigational New Drug application for EO-3021 has
been cleared by the U.S. Food and Drug Administration.
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 working to rapidly
advance EO-3021 into the clinic in the US across a range of solid
tumor indications, as well as exploring other opportunities through
new or existing partnerships and business development opportunities
to expand our novel 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 development activities, 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,"
"potential," "possible," "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, the impact of the continued
presence of COVID-19 on Elevation Oncology's business, 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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