EO-3021 is designed for GC/GEJ patients whose tumours express Claudin 18.2 and have progressed following prior therapy.
The FTD status aims to accelerate the development and review of products that address serious conditions and fulfil unmet medical needs.
This designation will facilitate the development of new therapies by providing more frequent interactions with the FDA and the potential for priority review and accelerated approval based on clinical data.
A clinical-stage antibody drug conjugate (ADC), EO-3021 consists of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) targeting Claudin 18.2, linked to a monomethyl auristatin E (MMAE) payload via a cleavable linker. This conjugation provides a drug-to-antibody ratio (DAR) of two.
Claudin 18.2 is typically found in gastric epithelial cells and becomes exposed during malignant transformation, making it a target for EO-3021.
Currently, Elevation Oncology is assessing EO-3021 in a Phase I trial involving patients with advanced, unresectable or metastatic solid tumours likely to express Claudin 18.2, including gastric, gastroesophageal junction, pancreatic, or oesophageal cancers.
The company holds exclusive rights for the development and commercialisation of EO-3021 in all global territories outside Greater China.
Elevation Oncology president and CEO Joseph Ferra said: “We are delighted to receive fast track designation for EO-3021, which marks an encouraging recognition of the unmet medical need in patients with Claudin 18.2-expressing tumours, as well as the potential for EO-3021 to deliver improved therapeutic outcomes.
“This designation is based on nonclinical and initial clinical data from our ongoing Phase I clinical trial. As we announced in August, early results showed a confirmed overall response rate of 42.8% in a Claudin 18.2-enriched subset of gastric and GEJ cancer. In addition, we observed differentiated tolerability, with minimal MMAE-associated toxicities, including no neutropenia or peripheral neuropathy/hypoesthesia.”