Elevation Oncology Expands Ongoing Phase 1 Clinical Trial of EO-3021 Globally, Dosing First Patient in Japan
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Insights
The expansion of Elevation Oncology's Phase 1 clinical trial to include sites in Japan is a significant step in the development of EO-3021, particularly due to the high prevalence of gastric cancer in the region. The focus on Claudin 18.2 as a therapeutic target is noteworthy, given its expression in most gastric adenocarcinomas. The ability of EO-3021, an antibody drug conjugate, to address this target could potentially offer a more nuanced treatment approach compared to existing therapies. The preliminary anti-tumor activity, along with safety and tolerability of EO-3021, will be critical in determining its viability as a treatment option.
Additionally, the association of Claudin 18.2 expression with objective response may provide insights into patient selection for future trials, potentially leading to more personalized treatment strategies. As an oncologist, the prospect of a new therapeutic modality that can be tailored to specific biomarker expression levels is promising, as it aligns with the broader trend towards precision medicine in oncology.
The initiation of patient dosing in Japan marks a pivotal moment for Elevation Oncology, as it allows for the assessment of EO-3021 across a more diverse patient population. This is particularly relevant for diseases like gastric cancer, which have differing incidence rates and potentially varying biological characteristics across populations. The trial's design, an open-label, multi-center dose escalation and expansion study, is typical for Phase 1 trials and is aimed at determining the optimal dose for further studies while assessing early signs of efficacy.
From a research perspective, the study's additional objective to assess the association between Claudin 18.2 expression and objective response is of high interest. It could provide valuable data on the biomarker's role as a predictive indicator of treatment efficacy, which is a key area of focus in oncology research. The timeline for data updates is also crucial, as it provides milestones that can influence the company's valuation and strategic planning.
For investors and stakeholders in Elevation Oncology, the expansion of the Phase 1 trial to Japan is a strategic move that could have implications for the company's market potential. Japan represents a significant market for gastric cancer treatments and successful trial results could open pathways for EO-3021's approval and commercialization in a region with a high demand for such therapies. Furthermore, the trial's progression and the anticipated data updates in mid-2024 and the first half of 2025 are events that will likely be monitored closely by the market for their potential impact on the stock's performance.
It is important to note that while early-stage clinical trials are essential for a drug's development, they also carry substantial risk. The outcomes of these trials can significantly affect a company's financial health, particularly for a biotech firm like Elevation Oncology, where much of the company's valuation is tied to its pipeline's success. Therefore, the trial's future results will be a determinant in shaping the company's trajectory and investor sentiment.
-- On track to provide update from ongoing Phase 1 clinical trial in mid-2024; additional data expected in 1H 2025 --
"We are pleased to expand our clinical development efforts outside of
"Despite recent advancements in the treatment of gastric cancer and improvements in mortality, there remains a significant need for new treatment options that offer patients improved outcomes," said Kohei Shitara, M.D., Chief, Department of Gastrointestinal Oncology, National Cancer Center Hospital East in Kashiwa,
Elevation Oncology's Phase 1 clinical trial (NCT05980416) is an open-label, multi-center dose escalation and expansion study to evaluate the safety, tolerability and preliminary anti-tumor activity of EO-3021. An additional objective of the study will be to assess the association of Claudin 18.2 expression and objective response. The study is recruiting patients with advanced unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction, pancreatic or esophageal cancers, at multiple sites in
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 transformation, 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.
Elevation Oncology has the exclusive rights to develop and commercialize EO-3021 in all global territories outside
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 oncology 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 junction, 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 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," "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
FAQ
What is the focus of Elevation Oncology's Phase 1 clinical trial involving EO-3021 (ELEV)?
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When can we expect updates from the Phase 1 clinical trial involving EO-3021?
