BOSTON - Elicio Therapeutics, Inc. (NASDAQ:ELTX), a biotechnology firm focusing on novel cancer immunotherapies, presented updated preliminary results from its Phase 1 AMPLIFY-7P clinical trial of ELI-002, an investigational cancer vaccine. The data, revealed at the Society for Immunotherapy of Cancer's 2024 Annual Meeting, shows a positive correlation between the vaccine-induced T cell response and disease-free survival (DFS) in patients with KRAS-mutant tumors.
The ongoing AMPLIFY-7P study examines ELI-002 in patients with solid tumors driven by mutant KRAS (mKRAS) who are at risk of disease recurrence post standard treatment. The trial has reached a key milestone with its Phase 2 enrollment expected to conclude in Q4 2024.
Preliminary findings up to September 11, 2024, show that all 12 evaluable patients exhibited mKRAS-specific T cell responses after receiving ELI-002, with those given the recommended Phase 2 dose of 4.9 mg showing a median response 12 times higher than the 1.4 mg dose group. These T cells targeted all seven KRAS mutations addressed by the vaccine, particularly the most common variants. Additionally, the magnitude of T cell response was associated with longer DFS, with the highest three quartiles of T cell responders not reaching median DFS, in contrast to the lowest quartile with a median DFS of 3.1 months.
Moreover, the vaccine prompted immune responses against patient-specific neoantigens in all patients treated with the recommended Phase 2 dose, indicating a broadening of the immune surveillance prompted by ELI-002. Safety data up to May 23, 2024, confirms that ELI-002 is well-tolerated with no severe adverse effects observed.
Elicio's Executive Vice President and Chief Medical (TASE:PMCN) Officer, Christopher Haqq, M.D., Ph.D., expressed optimism about the robust T cell expansion and the vaccine's potential for durable tumor immunosurveillance. The company awaits further data from the AMPLIFY-201 trial in December.
ELI-002, part of Elicio's AMP (OTC:AMLTF) platform, is designed to target the most common KRAS mutations found in approximately 25% of all solid tumors. The company's aim is to develop off-the-shelf vaccines to prevent high-prevalence cancers' recurrence, including mKRAS-positive pancreatic and colorectal cancers.
This article is based on a press release statement from Elicio Therapeutics.
In other recent news, Elicio Therapeutics adjourned its annual stockholders' meeting due to the absence of a quorum, with the reconvened meeting scheduled for November 21, 2024. Despite this, proxies received thus far have shown majority support for all proposals set to be voted on. In addition, Elicio Therapeutics received a Buy rating from Jones Trading, emphasizing the potential of its cancer vaccine candidate. Changes within the company also include the appointment of Robert Connelly as the Principal Accounting Officer and Principal Financial (NASDAQ:PFG) Officer, following the resignation of CFO and Treasurer, Brian Piekos. The company further aims to raise approximately $11.5 million through an underwritten public offering. Lastly, preliminary data from the AMPLIFY-7P Phase 1a study of its cancer vaccine candidate, ELI-002 7P, suggests a correlation between strong T cell responses and reductions in tumor biomarker levels.
InvestingPro Insights
As Elicio Therapeutics (NASDAQ:ELTX) advances its promising cancer vaccine ELI-002, investors should consider some key financial metrics and insights from InvestingPro. The company's market capitalization stands at $51.22 million, reflecting its current position in the biotechnology sector.
InvestingPro data reveals that Elicio has experienced a significant return of 11.74% over the last week, indicating recent positive market sentiment possibly linked to the encouraging clinical trial results. This short-term gain is particularly noteworthy given the stock's 47.4% decline over the past six months, suggesting a potential turnaround in investor perception.
However, it's crucial to note that Elicio is currently operating at a loss, with an adjusted operating income of -$41.33 million for the last twelve months as of Q2 2024. This aligns with an InvestingPro Tip stating that the company is not profitable over the last twelve months and that analysts do not anticipate profitability this year. This financial situation is common for early-stage biotech companies investing heavily in research and development.
Another InvestingPro Tip highlights that Elicio is quickly burning through cash, which is a critical factor for investors to monitor, especially given the company's focus on advancing its clinical trials. The company's ability to manage its cash burn rate while progressing its pipeline will be crucial for its long-term success.
For investors seeking a more comprehensive analysis, InvestingPro offers 5 additional tips that could provide deeper insights into Elicio's financial health and market position. These additional tips could be particularly valuable for understanding the company's potential as it approaches key milestones in its clinical trials.
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