On February 22, 2024 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, reported that it has expanded its ongoing Phase 1 clinical trial of EO-3021 outside the United States, dosing the first patient in Japan (Press release, Elevation Oncology, FEB 22, 2024, View Source;utm_medium=rss&utm_campaign=elevation-oncology-expands-ongoing-phase-1-clinical-trial-of-eo-3021-globally-dosing-first-patient-in-japan [SID1234640386]). This trial is evaluating the safety, tolerability and preliminary anti-tumor activity of EO-3021 in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction, pancreatic or esophageal cancers.

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"We are pleased to expand our clinical development efforts outside of the United States and into Japan where there is a large number of patients with gastric cancer who could benefit from EO-3021," said Valerie Malyvanh Jansen, M.D., Ph.D., Chief Medical Officer of Elevation Oncology. "Claudin 18.2 is expressed in most gastric adenocarcinomas and is increasingly recognized as an important therapeutic target, which can be effectively addressed with an antibody drug conjugate (ADC). We are excited to have dosed our first patient in Japan, as we continue to execute on our mission of delivering novel, selective cancer therapies that can offer better outcomes to patients."

"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, Japan and principal investigator on the Phase 1 clinical trial, "Based on preclinical and early clinical data, I believe EO-3021 has the potential to overcome the limitations of other therapeutic modalities to deliver benefit to patients with varying levels of Claudin 18.2 expression. I am excited to dose patients with EO-3021 and to have access to this much-needed option for patients in Japan."

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 the United States and Japan. Elevation Oncology expects to provide an update from the trial in mid-2024, with additional data expected in the first 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 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 Greater China.