Elevation Oncology is making strides in its antibody-drug conjugate (ADC) programs, particularly focusing on EO-3021 for gastric and gastroesophageal junction (GEJ) cancers. The company has initiated dosing in a Phase 1 clinical trial cohort evaluating EO-3021 in combination with ramucirumab or dostarlimab in patients with advanced gastric/GEJ cancer, addressing a significant unmet need in earlier lines of treatment.
EO-3021: Targeting Claudin 18.2 in Gastric/GEJ Cancers
EO-3021, a differentiated ADC targeting Claudin 18.2, is being developed for advanced, unresectable, or metastatic solid tumors, including gastric/GEJ cancer. Initial monotherapy data from the Phase 1 trial, reported in August 2024, showed a 42.8% confirmed overall response rate (ORR) in a biomarker-enriched population, alongside a favorable safety profile with minimal hematological toxicity, hepatotoxicity, and no peripheral neuropathy/hypoesthesia.
"We are rapidly advancing EO-3021 to address significant unmet needs in treating earlier lines of advanced gastric/GEJ cancer, where we believe we have a unique ability to improve on the standard of care," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology.
Combination Therapies and Clinical Trial Updates
The ongoing Phase 1 trial now includes combination cohorts evaluating EO-3021 with dostarlimab (a PD-1 inhibitor) in the first-line setting and with ramucirumab (a VEGFR2 inhibitor) in the second-line setting. The combination with dostarlimab aims to deliver synergistic benefits beyond existing immunotherapy and chemotherapy combinations, which are the current standard of care for first-line gastric/GEJ cancer.
The combination of EO-3021 and ramucirumab seeks to improve tolerability and anti-tumor activity compared to the approved combination of ramucirumab and paclitaxel, the standard second-line treatment. Initial data from these combination cohorts are expected in the fourth quarter of 2025 or the first quarter of 2026.
Monotherapy Expansion and Data Anticipation
Elevation Oncology is also continuing the dose expansion portion of the Phase 1 clinical trial of monotherapy EO-3021, focusing enrollment on patients with ≥25% Claudin 18.2 expression in tumor cells (IHC 1+/2+/3+). Additional safety and efficacy data from the dose escalation and expansion portions of the study are anticipated in the first half of 2025.
EO-1022: A HER3 ADC for Solid Tumors
In addition to EO-3021, Elevation Oncology is developing EO-1022, a HER3 ADC for HER3-expressing solid tumors, including breast cancer, EGFR-mutant non-small cell lung cancer, and pancreatic cancer. EO-1022 combines seribantumab (a fully human anti-HER3 monoclonal antibody) with a monomethyl auristatin E (MMAE) payload, utilizing site-specific conjugation to glycan. Preclinical data for EO-1022 is expected to be presented in the first half of 2025, with plans to file an Investigational New Drug (IND) application in 2026.
Financial Outlook
Elevation Oncology anticipates that its current cash, cash equivalents, and marketable securities will be sufficient to fund operations into 2026.
