Elicio Therapeutics, a clinical-stage biotechnology company (Nasdaq: ELTX) has recently announced the results from the Phase 1 AMPLIFY-201 study on ELI-002. This immunotherapy uniquely targets mKRAS-driven cancers through a three-component lymph node-targeted vaccine. By leveraging the "brain center" of the immune response, Elicio's novel approach to cancer targeting and treatment holds the potential to transform the lives of patients with solid tumors. As clinical trials continue, Elicio Therapeutics is committed to pioneering effective treatments that can revolutionize how cancer is treated and prevented, especially after other procedures have failed.
The innovative biotechnology company was founded in 2011 to explore the viability of ground-breaking Amphiphile technology, developed by Darrell Irvine Ph.D., Professor of Biological Engineering and Materials Sciences and Howard Hughes Investigator, at the Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology (MIT). Since its establishment, Elicio Therapeutics has remained committed to implementing a multidisciplinary approach to treating aggressive cancers. The company differentiates itself from competitors seeking similar medical solutions by emphasizing the need for therapies that can be manufactured quickly to meet a growing patient population's needs.
Elicio Therapeutics began its first patient studies in 2021, utilizing the Amphiphile technology Dr. Irvine and colleagues at MIT invented. The immunotherapy platform called AMP delivers therapeutic payloads directly to the lymph nodes to enhance the cancer-fighting mechanisms of the immune system to specifically target solid tumors due to their prevalence and sometimes untreatable nature. Since releasing the Phase 1 study results, Elicio Therapeutics has been compared to cancer vaccine pioneers. The AMPLIFY-201 trial demonstrates that the ELI-002 2P monotherapy may be able to effectively treat cancer by generating a large T-cell response in patients who have already tried chemotherapy and other off-the-shelf treatments.
Elicio Therapeutics' AMPLIFY-201 trial with ELI-002 was conducted in 25 patients whose pancreatic or colorectal cancer had certain KRAS mutations and were at high risk of the cancer returning after surgery and chemotherapy. Patients under these circumstances are left with little to no options as their cancers are deemed incurable. However, Elicio Therapeutics is looking to give these patients and their families a renewed sense of hope. AMPLIFY-201 results support this notion as the study had significantly better patient response rates versus past trials of cancer vaccines. These findings are covered in the company's paper published in Nature Medicine.
Of the 25 patients who participated in this clinical trial, 20 were diagnosed with pancreatic cancer and 5 had colorectal cancer. Out of this group, 84% of patients had a decline from baseline in their tumor biomarker response. Twenty-four percent of patients showed complete clearance and those achieving large T-cell responses experienced an 86% decrease in risk of progression or death. The efficacy of this Phase 1 trial could be due to the unique methodology of Amphiphile vaccines. After being injected subcutaneously, ELI-002 targets delivery to immune cells in the lymph nodes via molecular 'hitchhiking' leading to the expansion of tumor-specific, functional T-cell responses. By targeting KRAS mutations that cause 25% of solid tumors, ELI-002 harnesses the natural power of the human immune system to usher in a novel method for beating cancer and decreasing the likelihood of recurrence.
In light of Elicio Therapeutics' positive Phase 1 trial results, the company has initiated a randomized study for its Phase 2 trial. Elicio Therapeutics will monitor 135 patients during Phase 2 and test the company's targeting of all seven KRAS mutations. The biotechnology company plans to publish the results in 2025 and is anticipating a highly successful trial.
Elicio Therapeutics' mission to treat and prevent the occurrence of solid tumors may eventually create revolutionary methods for treating conditions that involve the body's immune response. If achieved, millions of patients and their families could live a life without experiencing the devastating impact of cancer and other diseases.
