Elevation Oncology (ELEV) Study Update summary

Key study results and clinical insights

• EO-3021 demonstrated a 42.8% objective response rate and 71.4% disease control rate in Claudin 18.2-enriched gastric/GEJ cancer patients (≥20% expression at IHC 2+/3+) in Phase 1 trials.

• All observed responses were partial and ongoing, limited to patients with higher Claudin 18.2 expression, supporting a biomarker-driven approach.

• EO-3021 showed a favorable safety profile, with minimal MMAE-associated toxicities, no neutropenia or peripheral neuropathy, and no Grade 4/5 treatment-related adverse events among 32 patients.

• Dose escalation identified 2.0 and 2.5 mg/kg as recommended doses for further study; dose expansion is underway.

• Pharmacokinetic data confirm site-specific conjugation increases ADC stability and reduces free MMAE, supporting improved safety.

Clinical development strategy and future plans

• Dose expansion and biomarker cutoff introduction are planned, with additional monotherapy and combination data expected in the first half of 2025.

• Combination cohorts with ramucirumab (second-line) and dostarlimab (first-line) will begin dosing by year-end 2024.

• The program aims to address unmet needs across first, second, and third-line settings, with long-term plans to expand into other Claudin 18.2-expressing solid tumors.

• Biomarker-driven patient selection is central to ongoing and future clinical development.

• Financial strength supports continued development, with $111M in cash as of June 30, 2024, and runway into 2026.

Expert perspectives and treatment landscape

• Claudin 18.2 is a validated biomarker in gastric/GEJ cancers, expressed in over 70% of tumors; about 60% have ≥20% expression at IHC 2+/3+.

• Current standard treatments offer limited efficacy, especially in later lines, highlighting the need for new targeted options.

• ADCs like EO-3021 may offer broader applicability and better tolerability than monoclonal antibodies, bispecifics, or CAR T therapies.

• EO-3021's safety profile is favorable, with manageable GI and ocular toxicities, and no severe hematologic or neurologic events; less than 10% discontinued due to adverse events.

• Combination strategies with ramucirumab and PD-1 inhibitors are considered promising and feasible.