Elevation Oncology Reports Promising Phase 1 Data for EO-3021 in Advanced Solid Tumors Expressing Claudin 18.2

Elevation Oncology, Inc., a biotechnology firm dedicated to developing precise cancer treatments, has announced initial positive data from its Phase 1 trial for EO-3021. This drug is being tested in patients with advanced solid tumors, particularly those likely to express Claudin 18.2, such as gastric, gastroesophageal junction (GEJ), pancreatic, or esophageal cancers.

Dr. Kohei Shitara, principal investigator on the trial, highlighted the urgent need for targeted treatments for Claudin 18.2-expressing tumors, noting the promising preliminary results from EO-3021. Dr. Valerie Malyvanh Jansen, Chief Medical Officer at Elevation Oncology, emphasized the drug's design aimed at maximizing efficacy while minimizing side effects, particularly those associated with the MMAE payload.

The trial's dose escalation phase included 32 patients, predominantly with gastric or GEJ cancer, who received varying doses of EO-3021. As of June 10, 2024, results indicated the drug was well-tolerated, with no Grade 4 or 5 treatment-related adverse events and minimal discontinuations due to adverse effects. Importantly, significant toxicities commonly linked to MMAE, such as neutropenia and peripheral neuropathy, were notably absent.

Common side effects reported included nausea, decreased appetite, fatigue, and diarrhea. Four patients experienced dose-limiting toxicities at the highest dose level, leading to the selection of slightly lower doses for further evaluation in the trial's next phase.

Efficacy data revealed that, among 15 evaluable patients with gastric or GEJ cancers, those with higher Claudin 18.2 expression (≥20% of tumor cells) showed a 42.8% objective response rate (ORR) and a 71.4% disease control rate (DCR). In contrast, patients with lower Claudin 18.2 expression had no objective responses and a DCR of 50%.

Elevation Oncology plans to proceed with the dose expansion phase, focusing on two specific doses of EO-3021 to further assess its safety, tolerability, and preliminary efficacy. This phase will also explore the relationship between Claudin 18.2 expression and treatment response, aiming to refine the biomarker criteria for future studies. Additional data from this phase are expected in the first half of 2025.

The company also intends to start combination trials by the end of 2024, exploring EO-3021 in conjunction with other treatments like ramucirumab and dostarlimab for advanced gastric or GEJ cancers in different treatment lines.

EO-3021 is a distinctive antibody-drug conjugate targeting Claudin 18.2, designed to deliver the MMAE payload specifically to cancer cells while sparing healthy tissue. This precise targeting is expected to offer improved efficacy and safety over existing treatments.

Elevation Oncology holds exclusive global rights to EO-3021 outside Greater China and is focused on developing selective treatments for various solid tumors with unmet medical needs. The company's pipeline includes another ADC targeting HER3, with a development candidate expected to be nominated in 2024.