Thursday, Elicio Therapeutics Inc (NASDAQ:ELTX) released new preliminary data from the ongoing AMPLIFY-7P Phase 1a study of its off-the-shelf investigational therapeutic cancer vaccine candidate, ELI-002 7P.
The preliminary data showed patients receiving ELI-002 7P at the Phase 2 dose of 4.9mg AMP-peptide were yet to reach the median disease-free survival (DFS) endpoint as of the May 24, 2024 data cutoff date.
The AMPLIFY-7P study is evaluating the 7-peptide formulation ELI-002 7P in patients with mKRAS-driven solid tumors following standard locoregional treatment.
Data were based on May 24, 2024, data cutoff date of 14 patients with minimal residual disease who enrolled in the Phase 1 cohort of the AMPLIFY-7P study, with a median follow-up for the DFS endpoint of 29.1 weeks:
The median DFS has not yet been reached (n=14).
The median disease-free survival (mDFS) has not been reached in patients receiving the 4.9mg AMP-peptide dose (n=8) vs. 12.6 weeks for patients receiving the 1.4mg AMP-peptide dose (n=6).
Patients achieving a reduction in their tumor biomarker levels had no progression events, compared to an mDFS of 11.0 weeks for patients whose tumor biomarker did not respond to ELI-002 7P.
Patients with an above-median T-cell response to ELI-002 have had no progression events.
The company expects to share additional clinical data updates from the AMPLIFY Phase 1 trials later in 2024 and the randomized Phase 2 interim analysis in the first quarter of 2025.
ELI-002 2P (2-peptide formulation) is currently being studied in an ongoing Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors following surgery and chemotherapy.
ELI-002 7P (7-peptide formulation) is currently being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer.
Concurrently, Elicio Therapeutics priced its approximately $11.5 million public offering of 500k shares and accompanying warrants to purchase 500k shares at a combined price of $5.00.
Price Action: ELTX shares are down 36.9% at $4.345 at last check Friday.
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