Elicio Therapeutics Reports Encouraging Phase 2 AMPLIFY-7P Trial Progress with Fewer Disease Events Than Projected
核心洞察
Elicio Therapeutics (搜索) reported fewer disease progressions and deaths than projected in its ongoing Phase 2 AMPLIFY-7P trial evaluating ELI-002 7P in patients with KRAS (搜索)-mutant pancreatic ductal adenocarcinoma (搜索).
The company demonstrated evidence of antigen spreading to patient-specific neoantigens beyond mKRAS (搜索) in December 2025, showing induction of de novo T cell responses against non-vaccine tumor neoantigens.
The event-driven primary disease-free survival analysis for the Phase 2 AMPLIFY-7P study is anticipated in the first half of 2026, with cash runway projected into Q3 2026.
Elicio Therapeutics (搜索) reported encouraging progress in its Phase 2 AMPLIFY-7P trial, with fewer disease progressions and deaths observed than initially projected in the ongoing 2:1 randomized study evaluating ELI-002 7P in patients with KRAS (搜索)-mutant pancreatic ductal adenocarcinoma (搜索) (PDAC (搜索)). The event-driven primary disease-free survival (DFS) analysis remains on track for the first half of 2026.
"We are encouraged by the continued observation of fewer disease progressions and deaths to date than projected in the 2:1 randomized trial, as well as by the durability of T-cell responses and clinical observations reported to date, which reinforce our confidence in ELI-002 7P's potential to favorably impact outcomes," said Robert Connelly, Chief Executive Officer of Elicio.
Clinical Progress and Immunological Evidence
In December 2025, Elicio reported evidence of antigen spreading to patient-specific neoantigens beyond mKRAS (搜索) in the ongoing Phase 2 AMPLIFY-7P trial. This development demonstrates induction of de novo T cell responses against non-vaccine tumor neoantigens and further supports the breadth and potential durability of the ELI-002 7P immune response in mKRAS-driven PDAC (搜索).
The company remains blinded to the Phase 2 AMPLIFY-7P trial clinical efficacy outcomes while continuing to advance the randomized trial in post-resection mKRAS (搜索) PDAC (搜索) patients.
ELI-002 7P Development Program
ELI-002 7P is an off-the-shelf immunotherapy candidate targeting the most common KRAS (搜索) mutations, which drive approximately 25% of all solid tumors. The 7-peptide formulation is designed to provide immune response coverage against seven of the most common KRAS mutations, thereby increasing the potential patient population for ELI-002.
The therapy utilizes Elicio's proprietary Amphiphile (AMP) platform, which delivers investigational immunotherapeutics directly to the lymph nodes by latching onto the protein albumin found at the local injection site as it travels to lymphatic tissue. This approach aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional immunotherapy strategies.
Regulatory and Development Timeline
Following completion of the primary DFS analysis, Elicio plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (搜索) (FDA) to finalize the Phase 3 trial design for ELI-002 7P in resected mKRAS (搜索) PDAC (搜索). The company intends to finalize the Phase 3 protocol and advance ELI-002 7P toward initiation of a registrational study, subject to regulatory alignment.
The company remains interested in expanding the development of ELI-002 7P to neoadjuvant and metastatic PDAC (搜索) settings, as well as other KRAS (搜索)-positive tumors.
Financial Position and Operations
Elicio reported a net loss of $39.5 million for 2025, compared to $51.9 million for 2024. Research and development expenses decreased to $24.9 million in 2025 from $33.7 million in 2024, primarily due to lower clinical costs as patients progressed into the observation phase of the Phase 2 study.
The company expects its current cash and cash equivalents, totaling $18.6 million as of December 31, 2025, along with projected at-the-market program proceeds, to support operations into Q3 2026, beyond the anticipated AMPLIFY-7P Phase 2 DFS analysis. Elicio raised net proceeds of approximately $4.9 million in Q4 2025 and $6.3 million in Q1 2026 through its established at-the-market program.
Previous Clinical Data
Updated AMPLIFY-201 Phase 1 data for PDAC (搜索) and colorectal cancer (搜索) presented at the ESMO Immuno-Oncology Congress 2024 showed a 16.3-month median recurrence-free survival and 28.9-month median overall survival for the full study population.