BOSTON - Elicio Therapeutics, Inc. (NASDAQ:ELTX), a clinical-stage biotech firm with a market capitalization of $56 million, announced the completion of patient enrollment for its Phase 2 study of ELI-002, a novel immunotherapy aimed at treating pancreatic cancer. The study, known as AMPLIFY-7P, has enrolled 135 patients with mutant KRAS-driven pancreatic ductal adenocarcinoma (PDAC) who are at high risk of relapse post-surgery. According to InvestingPro data, while the company maintains a healthy current ratio of 3.4, it faces challenges with cash burn and profitability.
The randomized trial is testing the safety, tolerability, and efficacy of ELI-002, a 7-peptide formulation designed to stimulate a robust immune response against several common KRAS mutations found in PDAC. Patients in the study were randomized to receive either ELI-002 or standard care observation, with the option for those in the observation group to cross over to the vaccine treatment upon confirmed disease progression.
The primary goal of the Phase 2 trial is to measure disease-free survival (DFS), with key secondary objectives including overall survival and vaccine immunogenicity. The first participant was dosed in January 2024, and an interim analysis by the Independent (LON:IOG) Data Monitoring Committee is scheduled for the first half of 2025. This analysis could lead to reporting on the primary endpoint, continuation to final DFS analysis, or potential determination of futility.
Elicio's Executive Vice President and Chief Medical (TASE:PMCN) Officer, Christopher Haqq, M.D., Ph.D., expressed optimism about the rapid enrollment and the potential of ELI-002 as an off-the-shelf monotherapy for PDAC patients. Phase 1a results had previously indicated a favorable safety profile and promising preliminary DFS data.
ELI-002 is part of Elicio's broader effort to develop off-the-shelf vaccines for high-prevalence cancers, leveraging their Amphiphile (AMP (OTC:AMLTF)) technology to target cancer-specific T cells more effectively. The stock has shown strong momentum recently, with analysts setting price targets between $9-10. InvestingPro subscribers can access 8 additional key insights about Elicio's financial health and market position.
This news article is based on a press release statement from Elicio Therapeutics. The company's forward-looking statements involve risks and uncertainties, and actual results may differ materially from those projected. Elicio does not undertake any obligation to update forward-looking statements beyond the date of the release. For comprehensive financial analysis and real-time updates on Elicio and other biotech companies, consider subscribing to InvestingPro.
In other recent news, Elicio Therapeutics has made significant strides in its Phase 1 AMPLIFY-7P clinical trial for ELI-002, a promising cancer vaccine. Preliminary results reveal a positive correlation between the vaccine-induced T cell response and disease-free survival in patients with KRAS-mutant tumors. Phase 2 enrollment is anticipated to conclude in Q4 2024. An upgrade from Jones Trading has also been received, highlighting the potential of Elicio's cancer vaccine candidate.
Recent developments within Elicio Therapeutics also include executive changes. Robert Connelly has been appointed as the Principal Accounting Officer and Principal Financial (NASDAQ:PFG) Officer, following the resignation of CFO and Treasurer, Brian Piekos. In terms of financial moves, the company is planning to raise approximately $11.5 million through an underwritten public offering.
These recent developments are part of Elicio's ongoing efforts to pioneer effective cancer immunotherapies. As the company advances its clinical trials and navigates these changes, it continues to maintain a neutral and fact-based approach to its operations and communications.
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