Elevation Oncology's EO-3021 Gets FDA Fast Track for Advanced Gastric Cancer

BOSTON, Sept. 23, 2024 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV) has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to EO-3021, a unique antibody drug conjugate (ADC), for treating patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer that express Claudin 18.2 and have progressed despite previous treatments.

Joseph Ferra, President and CEO of Elevation Oncology, expressed his satisfaction with the FDA's decision, stating, "This designation acknowledges the urgent need for better treatments for patients with Claudin 18.2-expressing tumors and the potential of EO-3021 to provide enhanced therapeutic outcomes." The Fast Track designation was granted based on nonclinical and early clinical data from an ongoing Phase 1 clinical trial, which showed a confirmed overall response rate of 42.8% in a subset of patients with Claudin 18.2-enriched gastric and GEJ cancer. Additionally, the trial indicated favorable tolerability, with minimal toxicities commonly associated with MMAE, such as neutropenia or peripheral neuropathy/hypoesthesia. Ferra added, "We are excited about the potential to accelerate the delivery of EO-3021 and anticipate advancing through monotherapy dose expansion, reporting more data in the first half of 2025, and starting the combination portion of our study later this year."

The FDA's Fast Track process is designed to expedite the development and review of drugs intended to treat serious or life-threatening conditions when preliminary data show the potential to meet unmet medical needs. Drugs with this designation may benefit from more frequent interactions with the FDA to discuss development plans and may also be eligible for priority review and accelerated approval based on clinical data.

EO-3021 is a distinguished clinical-stage ADC that has a high potential in its class. It comprises an immunoglobulin G1 (IgG1) monoclonal antibody that targets Claudin 18.2, and a monomethyl auristatin E (MMAE) cytotoxic agent linked via a cleavable linker, achieving a drug-to-antibody ratio of 2. Claudin 18.2 is a specific form of Claudin 18, typically found in gastric epithelial cells. When malignant transformation disrupts these tight junctions, Claudin 18.2 becomes exposed, making it accessible to targeting agents. Elevation Oncology is currently assessing EO-3021 in a Phase 1 trial (NCT05980416) involving patients with advanced, unresectable, or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction, pancreatic, or esophageal cancers.

Elevation Oncology holds exclusive rights to develop and commercialize EO-3021 globally, excluding Greater China.

Elevation Oncology is a pioneering oncology company dedicated to the discovery and development of selective cancer therapies for patients with significant unmet medical needs across various solid tumors. The company's expertise in antibody-drug conjugates (ADCs) is driving the advancement of an innovative pipeline, initially targeting Claudin 18.2 and HER3, two clinically validated targets in oncology. EO-3021 is their lead candidate, currently in a Phase 1 trial for patients with advanced, unresectable, or metastatic solid tumors likely to express Claudin 18.2. In addition, the company plans to nominate a development candidate for a second program targeting HER3 in patients with solid tumors that overexpress HER3 in 2024.