Elevation Oncology Highlights Clinical Data for SYSA1801 (EO-3021) to be Presented by Partner CSPC Pharmaceutical Group Limited at ASCO 2023

Rhea-AI Summary

Elevation Oncology has announced the selection of an abstract for SYSA1801 (EO-3021) Phase 1 clinical data for presentation at the ASCO 2023 Annual Meeting in Chicago, from June 2-6, 2023. The ongoing Phase 1 study is focused on evaluating SYSA1801 in patients with Claudin 18.2-positive advanced solid tumors, conducted in partnership with CSPC Pharmaceutical Group in China. Elevation plans to advance its clinical trial for EO-3021 in the U.S. in the second half of 2023. EO-3021 targets Claudin 18.2, a significant unmet need in oncology, particularly for gastric and pancreatic cancers, with no existing approved therapies. The U.S. FDA has cleared an Investigational New Drug application for EO-3021.

Positive

• Abstract featuring EO-3021 data selected for ASCO 2023 poster presentation.
• Ongoing Phase 1 study demonstrates progress in treating Claudin 18.2-positive tumors.
• Plans to initiate a U.S. Phase 1 clinical trial in the second half of 2023.
• EO-3021 is targeting an unmet medical need with no current approved therapies.

Negative

• None.

NEW YORK, April 26, 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, today announced that an abstract featuring SYSA1801 (EO-3021) Phase 1 clinical data has been selected for a poster presentation and poster discussion at the upcoming American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, being held June 2-6, 2023 in Chicago, IL. The ongoing Phase 1 dose escalation and dose expansion study is evaluating SYSA1801 in patients with Claudin 18.2-positive advanced solid tumors and is being conducted in China by Elevation Oncology's partner, CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093). Elevation Oncology remains on track to initiate a Phase 1 clinical trial in the U.S. evaluating EO-3021 in the second half of 2023.

"Claudin 18.2 is a clinically validated oncology target that is expressed in several high unmet need cancers, including gastric, esophageal and pancreatic, among others, and there are currently no approved targeted therapies for Claudin 18.2-expressing tumors," said Valerie Malyvanh Jansen, M.D., Ph.D., Chief Medical Officer of Elevation Oncology. "We believe EO-3021 has the potential to address unmet needs for patients with Claudin 18.2-expressing tumors, and we look forward to our partner, CSPC, presenting at ASCO 2023."

ASCO 2023 Presentation Details:

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. ET
Poster Discussion Date and Time: Saturday, June 3, 2023, at 1:15 p.m. ET
Abstract Number: 3016
Poster Number: 214

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 only 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, 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," "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 COVID-19 pandemic 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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SOURCE Elevation Oncology

FAQ

What is the focus of the SYSA1801 (EO-3021) Phase 1 clinical trial?

The trial focuses on evaluating SYSA1801 for patients with Claudin 18.2-positive advanced solid tumors.

When and where will the ASCO 2023 presentation occur?

The ASCO 2023 presentation will take place in Chicago from June 2-6, 2023, with the poster discussion on June 3.

What is the significance of EO-3021 in the oncology market?

EO-3021 targets Claudin 18.2, addressing a significant unmet need in treating solid tumors such as gastric and pancreatic cancers.

Who is conducting the Phase 1 trial for EO-3021 in China?

CSPC Pharmaceutical Group Limited is conducting the Phase 1 trial for EO-3021 in China.

What are the expected next steps for EO-3021 after ASCO 2023?

Elevation Oncology plans to initiate a Phase 1 clinical trial for EO-3021 in the U.S. in the second half of 2023.