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By Jeremy Golden, Benzinga
A phase 2 trial by a clinical-stage biotechnology company is kicking into full gear.
As part of its randomized phase 2 AMPLIFY-7P study of ELI-002 7P as an adjuvant monotherapy in Kirsten Rat Sarcoma (KRAS) mutated pancreatic ductal adenocarcinoma (PDAC), Elicio Therapeutics Inc. (NYSE: ELTX) has dosed the first patient at Northwell Health Cancer Institute and the Feinstein Institutes for Medical Research in New York.
ELI-002 7P is an investigational therapeutic cancer vaccine developed with Elicio’s proprietary lymph node-targeting Amphiphile (AMP) technology to treat cancers driven by seven common mutations in KRAS: G12D, G12R, G12V, G12A, G12C, G12S and G13D. Those are present in 25% of all solid tumor cancers and 88% of PDAC patients.
This is in contrast to other KRAS-targeted therapeutics in development, particularly small molecule KRAS inhibitors. Those target fewer mutations – potentially limiting the number of patients who can be treated – while also limiting the duration of benefit due to the development of escape mutants.
The AMPLIFY-7P study builds on preliminary positive findings from the 2-peptide formulation of ELI-002 published in Nature Medicine. That data demonstrated tumor biomarker reduction, with strong T cell responses that correlated with reduced risk of relapse and death.
Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development and Chief Medical Officer, anticipates results from this study will yield definitive data to support clinical efficacy assessment. Initial interim data on ELI-002 7P monotherapy from phase 1A arm will be shared in the first half of 2024, the company said.
“Approximately 90% of pancreatic cancers are positive for KRAS mutations, with only rare G12C mutations, about 1%, amenable to small molecule treatment,” Haqq said. “ELI-002 represents a cancer vaccine approach that could potentially address the much broader spectrum of pancreatic cancer KRAS mutations.”
In January, Elicio presented a Trial in Progress poster on the design of the AMPLIFY-7P trial at the ASCO Gastrointestinal Cancers Symposium in San Francisco, California.
The poster describes the phase 1 and randomized phase 2 study of ELI-002 7P, an investigational therapeutic cancer vaccine administered as an adjuvant monotherapy treatment for patients with KRAS-mutated pancreatic ductal adenocarcinoma (PDAC).
“ELI-002 is an off-the-shelf cancer vaccine candidate developed with our proprietary Amphiphile (“AMP”) platform which provides a new ability to deliver these treatments effectively to the ‘command center’ of the immune response – the lymph nodes – where tumor-fighting T cells are generated and equipped,” Haqq said. “We are progressing our AMP-powered, lymph node-targeted cancer vaccine, ELI-002 7P, as a monotherapy in an adjuvant setting for patients with pancreatic cancer, and recently dosed the first patient in the randomized Phase 2 cohort.”
“Patients with RAS mutated pancreatic cancers who have positive circulating tumor DNA post-surgery are often quick to relapse,” added Zev A. Wainberg, M.D., Professor of Medicine, University of California, Los Angeles (UCLA), Co-Director, the UCLA GI Oncology Program. “Our current standard of care for these patients is observation — there are no treatments given during this ‘wait and see’ observation window before relapse. As we progress to Phase 2 of the study, we seek to compare ELI-002 7P to our current standard of care to further evaluate its antitumor activity and clinical benefit in the adjuvant setting as well as with bulkier cancer treated at the time of relapse in crossover patients with mKRAS-driven pancreatic cancer.”
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