Elicio Therapeutics Announces Positive Interim Data from the Phase 1 Study of an Investigational Therapeutic Cancer Immunotherapy, ELI-002, in Patients with High Relapse Risk Pancreatic and Colorectal Cancer at the ASCO Annual Meeting - Seite 2

Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer, said, “ELI-002 is designed with our proprietary AMP technology, which allows for smart delivery to the lymph nodes, the ‘brain center’ of the immune system. The immune responses observed were robust and durable in addition to being able to carry out multiple anti-tumor functions. These data validate the clinical activity of ELI-002 with two peptides and support our bridge to the 7-peptide formulation of ELI-002, designed to stimulate an immune response against the seven most common KRAS mutations present in 25% of solid cancer patients. We are grateful to the patients, caregivers, physicians and study staff for their contribution to this study.”

Presentation summary:

Title: AMPLIFY-201, a first-in-human safety and efficacy trial of adjuvant ELI-002 2P immunotherapy for patients with high-relapse risk with KRAS G12D- or G12R-mutated pancreatic and colorectal cancer.
Abstract #: 2528
Presenter: Eileen O’Reilly, M.D., Winthrop Rockefeller Endowed Chair of Medical Oncology; Co-Director, Medical Initiatives, David M. Rubenstein Center for Pancreatic Cancer Research; Section Head, Hepatopancreaticobilary & Neuroendocrine Cancers, Memorial Sloan Kettering Cancer Center (MSK)

Study Design

• AMPLIFY-201 is a multicenter Phase 1 trial assessing the safety, immunogenicity and antitumor activity of ELI-002 2P as a monotherapy in patients with mutant KRAS-driven tumors who are at high risk for relapse due to detection of MRD following standard surgery and chemotherapy.
• ELI-002 2P is comprised of two AMP-modified mutant KRAS peptide antigens (Amph-mKRAS G12D and Amph-mKRAS G12R) and an AMP TLR-9 agonistic DNA adjuvant (Amph-CpG-7909).
• There were five cohorts of patients who received a 1.4 mg fixed dose of the two mutant KRAS peptide antigens and different doses of Amph-CpG-7909 (0.1 mg, 0.5 mg, 2.5 mg, 5.0 mg or 10.0 mg).
  

Study Results

• ELI-002 2P was very well-tolerated with no Grade ≥3 related adverse events (AEs), no cytokine release syndrome and no dose limiting toxicities.
• A high proportion of ELI-002 2P patients had tumor biomarker reduction (77%) with a subset achieving clearance (32%).
• Notable mKRAS-specific T cell responses were induced with an average of a 56-fold [range 2-423-fold] increase directly ex vivo. The T cell infiltration was 10 to 29-fold higher than the literature in pancreatic tumors.
• The recommended Phase 2 dose (RP2D) is 10 mg of Amph-CpG-7909.

Mutant KRAS drives 25% of solid human cancers with an overall poor prognosis and high relapse risk and limited therapeutic options. In the Phase 1 AMPLIFY-201 study, ELI-002 targets two of the KRAS mutations, G12R and G12D, the most commonly occurring variants in pancreatic, colorectal, non-small cell lung, ovarian, biliary and gallbladder cancers. The proprietary AMP technology allows for ELI-002 to “educate” T cells to recognize the G12R and G12D KRAS mutations, which allows them to then target these cancers for elimination. Most other mKRAS-targeted therapeutics in development — particularly small molecule mKRAS inhibitors — are only able to target one or two KRAS mutations. Elicio has developed a broad spectrum 7-peptide formulation of ELI-002 currently being assessed in a Phase 1/2 study (NCT05726864).