Elevation Oncology is advancing EO-3021, a Claudin 18.2 antibody-drug conjugate (ADC), in both monotherapy and combination settings for patients with Claudin 18.2-expressing gastric or gastroesophageal junction (GEJ) cancer. Initial Phase 1 data showed a 42.8% confirmed objective response rate (ORR) in a Claudin 18.2-enriched subset of gastric and GEJ cancer patients, alongside a favorable safety profile. The company has progressed into the dose expansion portion of the Phase 1 trial, with additional monotherapy data expected in the first half of 2025.
Clinical Trial Progress and Data
In August 2024, Elevation Oncology reported initial clinical data from the dose escalation portion of the Phase 1 trial of EO-3021. The data, cut off on June 10, 2024, revealed that in seven patients with Claudin 18.2 expression in ≥20% of tumor cells (IHC 2+/3+), the objective response rate (ORR) was 42.8%, with three confirmed partial responses. The disease control rate (DCR) was 71.4%, including two patients with stable disease. The trial (NCT05980416) is ongoing in patients with advanced, unresectable, or metastatic gastric/gastroesophageal adenocarcinoma that express Claudin 18.2.
Safety and Tolerability
EO-3021 has demonstrated a generally well-tolerated safety profile. Minimal hematological toxicity or hepatotoxicity was observed, and no peripheral neuropathy/hypoesthesia was reported in the safety population of 32 patients treated with EO-3021. Initial safety data suggests minimal payload-associated toxicity and limited overlapping toxicity with standard-of-care agents, including PD-1 inhibitors and chemotherapies.
Combination Therapy Strategy
Elevation Oncology plans to present preclinical data on the combination potential of EO-3021 with VEGFR2 or PD-1 inhibitors at the ESMO Immuno-Oncology Annual Congress 2024 (ESMO-IO 2024) in December. Dosing in the combination portion of the Phase 1 trial of EO-3021 is expected to begin in Q4 2024. These combination cohorts will explore EO-3021 with ramucirumab (a VEGFR2 inhibitor) in the second-line setting and with dostarlimab (a PD-1 inhibitor) in the front-line setting, following clinical supply agreements with Lilly and GSK, respectively.
Fast Track Designation
The U.S. Food and Drug Administration (FDA) granted Fast Track designation (FTD) to EO-3021 in September 2024 for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy. This designation is designed to expedite the development and review of therapeutic candidates that address unmet medical needs in serious or life-threatening conditions.
Financial Status
As of September 30, 2024, Elevation Oncology had cash, cash equivalents, and marketable securities totaling $103.1 million, expected to be sufficient to fund operations into 2026.
