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By Jeremy Golden, Benzinga
An estimated 609,820 people will die of cancer in the United States this year, according to the National Cancer Institute. Promising results from a 12-year-old clinical-stage biotechnology company have experts optimistic about the future of treating this deadly disease.
With its proprietary Amphiphile or “AMP” platform, Elicio Therapeutics Inc. (NASDAQ: ELTX) has developed multiple cancer vaccine candidates that concentrate an array of different immunogens in the lymph nodes.
ELI-002 is Elicio’s lead clinical program for Kirsten rat sarcoma (KRAS) driven cancers caused by a mutation of the KRAS gene. An “off the shelf” approach designed to stimulate an immune response against the seven KRAS mutations driving 25% of solid tumors, ELI-002 is currently being studied in AMPLIFY-201 – a phase 1 dose escalation study – and AMPLIFY-7P, a phase 1/2 study.
In September, Elicio released new information about the vaccine candidates in its pipeline at the ninth AACR Special Conference on Pancreatic Cancer in Boston. The positive preliminary relapse-free survival (RFS) data from the ongoing AMPLIFY-201 study demonstrated an 86% reduction in risk of progression or death in patients with large T-cell responses induced by ELI-002 2P, a 2-peptide formulation designed to treat cancers driven by G12D and G12R mutations in KRAS. Despite the AMPLIYF-201 study not including a control arm, the median RFS of over 16 months is significantly longer than what has been seen in other studies of similar patient groups.
“Patients with mutant KRAS cancers, particularly pancreatic and colorectal cancers, have a poor prognosis with limited treatment options when tumor DNA or protein biomarkers are detected after standard surgery and chemotherapy,” said Eileen M. O’Reilly, M.D., Winthrop Rockefeller Endowed Chair of Medical Oncology and Co-Director of Medical Initiatives at David M. Rubenstein Center for Pancreatic Cancer Research. “We are encouraged by the early data showing ELI-002 induced T cells can positively impact clinical endpoints including the risk of relapse and death in this study.”
Targeting Immunogens To Lymph Nodes
Elicio has demonstrated preclinically that Amphiphiles target and concentrate an array of different immunogens in the lymph nodes, which are located throughout the body on the lymphatic vessels at various intervals along the lymphatic routes.
During the process of circulating throughout the lymphatic system, lymph fluid accumulates antigens and other biomolecules captured from the tissues. This fluid then drains into the lymph nodes, where it encounters T cells and B cells congregating together with antigen-presenting cells (APCs).
Targeting the immunogens in the lymph nodes has been proven to result in tumor or pathogen-targeted immunity, including potent T cell and humoral responses, in preclinical trials.
Alongside AMPLIFY-201, ELI-002 7P is currently being studied in AMPLIFY-7P, a phase 1/2 trial in patients with high relapse risk mKRAS-driven solid tumors. Designed to provide immune response coverage against seven of the most common KRAS mutations, the ELI-002 7P formulation increases the potential patient population for ELI-002 while possibly reducing the chance of bypassing resistance mechanisms.
Moving forward in early 2024, Elicio Therapeutics plans to initiate a randomized phase 2 trial studying ELI-002 7P as a monotherapy in adjuvant PDAC patients.
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