Elicio Therapeutics Inc（ELTX）のニュースとイベントELTXElicio Therapeutics Inc

Q3 R&D Expenses Decrease to $4.9M

Reports Q3 R&D expense decreased to $4.9M from $5.0M, primarily due to lower clinical trial costs as patients moved into the follow-up phase of the Phase 2 camupepimut study, offset by higher personnel costs.

Elicio Therapeutics Announces Phase 2 Study Results for Camupepimut

Elicio Therapeutics announced results from the randomized Phase 2 AMPLIFY-7P study of camupepimut, presented in a late-breaking Proffered Paper oral session at the European Society for Medical Oncology, or ESMO, Congress 2026 in Madrid, Spain, and simultaneously published in Nature Medicine. Across multiple pre-specified analyses, camupepimut demonstrated consistent and favorable treatment-effect trends in patients with and without detectable baseline ctDNA and in patients without prior radiation. While the study did not meet its pre-specified primary disease-free survival endpoint in the intent-to-treat population, the results should be considered in the context of a baseline imbalance in ctDNA positivity, a strong predictor of recurrence, which was more prevalent in the camupepimut arm. Translational analyses also demonstrated broad, persistent mutant KRAS-specific T-cell responses associated with longer DFS. Together, these findings inform a refined Phase 3 development strategy. In the 93 patients with baseline ctDNA-negative status, median DFS was not reached in the camupepimut arm vs. 21.2 months in the observation arm. Recurrence or death was observed in 27.4% of camupepimut-treated patients vs. 48.4% of patients in observation. A consistent treatment effect was also observed in the smaller, higher-risk baseline ctDNA-positive subgroup. Median DFS was 4.3 months with camupepimut vs. 1.9 months with observation. Prior radiation predicted lower baseline lymphocyte counts and reduced camupepimut-induced mKRAS T cell responses. In pre-specified analysis, patients who had not received prior radiation had median DFS of 23.8 months with camupepimut vs. 10.4 months with observation. Baseline ctDNA status emerged as a particularly strong prognostic marker. In a pooled analysis across treatment groups, median DFS was 4.2 months for ctDNA-positive patients versus 24.0 months for ctDNA-negative patients. Patients with baseline ctDNA positivity were more prevalent in the camupepimut arm than in the observation arm. A multivariable model adjusting for baseline factors estimated an association between camupepimut treatment and lower recurrence risk, while elevated CA19-9 and positive baseline ctDNA were associated with higher risk. Six-month DFS was 75.7% with camupepimut vs. 61.7% with observation, a 14.0 percentage-point difference immediately following the treatment period supports evaluating treatment duration in future studies. Camupepimut induced mutant KRAS-specific T-cell responses in 99% of evaluable treated patients (median 44.3-fold increase from baseline. Among patients evaluated for T-cell subsets, 85% generated both CD4 and CD8 responses. Responses persisted at least 46 weeks from baseline in 95.5% of evaluable treated patients; 13 of 15 patients in a selected subset showed responses to additional tumor targets. In an exploratory analysis, stronger camupepimut-induced mutant KRAS-specific T-cell responses were associated with significantly longer DFS. Median DFS was not reached among patients with immune responses above a previously identified threshold vs. 6.08 months among those below the threshold. Camupepimut was generally well tolerated, with no new safety signals observed. Grade 3 or higher adverse events occurred in 10.4% of patients receiving camupepimut vs. 14.6% under observation; serious adverse events occurred in 6.3% and 8.3%, respectively. No adverse events led to withdrawal of study medication. Elicio plans to discuss the totality of AMPLIFY-7P findings with the FDA to inform a potential Phase 3 study in adjuvant pancreatic cancer. Areas for consideration include baseline ctDNA and other prognostic factors in stratification and patient selection, treatment duration, and combination strategies intended to deepen or sustain mutant KRAS-specific immune activity. Any future study design remains subject to regulatory discussion and further development planning.

Elicio CEO Says ELI-002 7P Shows Anti-Tumor Potential

"The encouraging clinical observations reported to date, including multiple complete responses following ELI-002 7P treatment and subsequent checkpoint inhibition, further support the promise of our AMP platform approach and its potential to generate durable anti-tumor immune responses," said Robert Connelly, Chief Executive Officer of Elicio. "Our recent financing provided us with the capital needed to evaluate initial data from our planned Phase 1 combination study of ELI-002 7P with a RAS small molecule inhibitor with or without an anti-PD-1 inhibitor, which is anticipated to begin in the fourth quarter of this year. We are excited to advance our combination strategy and hope to unlock the full potential of our AMP platform to deliver durable clinical benefit for patients with metastatic pancreatic cancer."