Elicio Therapeutics' KRAS-Targeting Cancer Vaccine Fails Primary Endpoint in Phase 2, Shares Plunge Over 70%

YaoRongQuan DataMonitoring shows: Recently,Elicio Therapeutics, Inc. (NASDAQ: ELTX) announced on June 15, 2026, the disclosure of key top-line data from the randomized Phase II AMPLIFY-7P study of its core KRAS-targeted cancer vaccine, ELI-002 7P. The trial targeted patients with Stage I-III mutantKRAS Pancreatic Ductal Adenocarcinoma (PDAC) Adjuvant Therapy PopulationLaunch.

A total of 144 subjects were enrolled. The prespecified primary endpoint of the trial was disease-free survival (DFS) in the intent-to-treat population; ultimately, this efficacy endpoint was not met in the overall population. After randomization, most prognostic factors remained balanced between the two arms. However, the proportion of patients with R1 resection margins (residual disease) was 19% in the ELI-002 7P dosing arm, compared to only 10% in the observation-only arm. As R1 resection is a well-established adverse prognostic indicator associated with a high risk of recurrence, the company concluded that this significant imbalance in baseline characteristics substantially detracted from the overall efficacy data.

Post-hoc stratified analysis demonstrated a clear benefit signal in the R0 complete resection margin subgroup, which accounted for 84% of the total population. In this subgroup, the median disease-free survival (DFS) was 23.8 months for the ELI-002 7P group versus 12.8 months for the observation group, with a hazard ratio of 0.65 (p=0.048). The absolute recurrence rate at 18 months was reduced by 9.5% compared to the control group. Overall, the drug’s safety profile was manageable, with no treatment-related discontinuations or deaths reported.

The company simultaneously announced its adjusted Phase III clinical development strategy,The Phase III trial will enroll only patients with R0 complete resection and minimal residual disease (lower risk of recurrence), and optimize the dosing cycle to extend the duration of treatment.; The company’s management disclosed that current cash reserves are sufficient to sustain operations through the fourth quarter of 2026, while simultaneously evaluating various strategic options, including multiple rounds of financing and out-licensing of pipeline assets via business development (BD) partnerships;

On the day of the announcement, the stock price fell by more than 72% at its lowest point during trading. Mayank Mamtani, an industry analyst at B. Riley, commented that the negative results from the Phase II trial in the overall population have weakened short-term commercialization expectations for the pipeline, and the future value of the project will now entirely depend on validation data from the Phase III trial in the subgroup with low residual disease.

References: