The stock of Elevation Oncology Inc. ELEV is trading lower on Tuesday after the company reported initial data from the dose escalation portion of the ongoing Phase 1 trial of EO-3021 in patients with advanced, unresectable, or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction, pancreatic, or esophageal cancers.
As of the data cutoff date of June 10, 32 patients had been treated. EO-3021 was observed to be generally well-tolerated. No Grade 4 or 5 treatment-related adverse events were reported, and less than 10% of patients discontinued EO-3021 due to adverse events.
Fifteen patients with gastric or GEJ cancers were evaluable for efficacy.
Seven of these 15 patients (47%) had tumors with Claudin 18.2 expression in ≥20% of tumor cells at IHC 2+/3+.
- In seven patients with Claudin 18.2 in ≥20% of tumor cells at IHC 2+/3+, the objective response rate (ORR) was 42.8% (three confirmed partial responses, one of which was confirmed following data cutoff).
- The disease control rate (DCR) was 71.4%, including two patients with stable disease (SD).
- In eight patients with Claudin 18.2 in <20% of tumor cells at IHC 2+/3+, the ORR was 0%, and the DCR was 50%, including four patients with SD. Investors are probably reacting to this.
Elevation Oncology plans to initiate enrollment in the dose expansion portion of the ongoing Phase 1 trial, further exploring two doses of EO-3021: 2.0 mg/kg IV Q3W and 2.5 mg/kg IV Q3W. These doses were selected to characterize EO-3021 to select an optimized dose for further clinical development.
Elevation Oncology is working to identify the appropriate biomarker threshold and plans to introduce a biomarker cutoff as part of the dose expansion portion of this Phase 1 trial. Elevation Oncology expects to share additional data from the Phase 1 trial, including from the dose expansion cohort, in the first half of 2025.
Elevation Oncology expects its $110.8 million cash, cash equivalents, and marketable securities as of June 30, 2024, to be sufficient to fund its current operations into 2026.
Price Action: ELEV stock is down 59% at $0.8733 at the last check Tuesday.
Image by PDPics from Pixabay
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