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Elicio's camupepimut misses Phase 2 DFS endpoint in pancreatic cancer, but subgroups steer Phase 3 plans

🇺🇸 Elicio Therapeutics, Inc. (ELTX) · Thu 05 Nov 2026

Elicio Therapeutics says pre-specified subgroup analyses from AMPLIFY-7P will shape Phase 3 design, despite the trial missing its primary disease-free survival endpoint in the overall population.

Elicio Therapeutics reported third-quarter 2026 results on 5 November, alongside a business update on camupepimut, its candidate for resected pancreatic ductal adenocarcinoma (PDAC).

The Phase 2 AMPLIFY-7P trial did not meet its primary endpoint of disease-free survival (DFS) in the intent-to-treat population. The company says, however, that pre-specified subgroup analyses showed a lower risk of recurrence or death in three groups: patients who were ctDNA-negative, patients who were ctDNA-positive, and patients who had received no prior radiation.

Elicio says these subgroup findings will inform the design of a Phase 3 programme in the adjuvant setting. No further details on the Phase 3 design were included in the material available.

The company also plans to begin a Phase 1 trial in the fourth quarter of 2026 combining camupepimut with daraxonrasib, with or without nivolumab.

On financing, Elicio reported cash of $30.9 million, which it expects to fund operations into the second quarter of 2027.

What it means for your team

  • A missed primary endpoint with positive pre-specified subgroup signals typically prompts regulators to scrutinise how subgroups are used in any later pivotal design; sponsors need robust justification for enrichment strategies.
  • The inclusion of ctDNA status as a stratifying factor points to biomarker-driven trial design, which may raise questions about assay validation and standardisation.
  • Cash guidance only into Q2 2027 means Phase 3 progress will depend on further funding or partnering, a factor for teams assessing the programme's timelines.

Company's press release (SEC filing): Elicio Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Elicio Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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