Elicio Therapeutics plots Phase 3 PDAC strategy on AMPLIFY-7P data
Elicio Therapeutics has reported new pre-specified analyses from its randomised Phase 2 AMPLIFY-7P trial in resected pancreatic ductal adenocarcinoma (PDAC), with subgroup data pointing toward a targeted Phase 3 strategy built around circulating tumour DNA (ctDNA) status and prior radiation history.
The Boston-based company said the analyses, presented as a late-breaking proffered paper at ESMO Congress 2026 and published in Nature Medicine, showed a 49% reduction in the risk of disease recurrence or death among ctDNA-negative patients at baseline, a 43% reduction among ctDNA-positive patients, and a 41% reduction in patients without prior radiation. A multivariable analysis adjusting for baseline prognostic imbalances estimated a 53% reduction in the hazard of recurrence or death (hazard ratio 0.47; p=0.0086).
Elicio was careful to note that AMPLIFY-7P did not meet its primary disease-free survival endpoint in the intent-to-treat population, a distinction that will matter to investors and clinicians when weighing the significance of the subgroup findings.
Combination strategies and pipeline progress
Robert Connelly, President and Chief Executive Officer, said the ctDNA stratification data would inform patient selection and dosing in the planned Phase 3 adjuvant study. The company is also targeting a fourth-quarter 2026 initiation for a Phase 1 trial combining camupepimut with daraxonrasib, a direct RAS inhibitor, with or without nivolumab, in metastatic KRAS-mutated PDAC. That design is supported by previously reported complete radiographic and metabolic responses in three metastatic PDAC patients who received camupepimut followed by nivolumab-based therapy.
A separate investigator-initiated Phase 1 neoadjuvant study, led by Memorial Sloan Kettering Cancer Center and funded through a partnership between The Lustgarten Foundation and Break Through Cancer, is ongoing in resectable and borderline resectable PDAC.
Elicio also highlighted preclinical data for AMP-CpG (ELI-004), its investigational TLR-9 agonist adjuvant. Intratumoral dosing produced complete tumour responses in 50% of treated animals in head and neck cancer models and 100% in melanoma models, the company said. The data will be presented at SITC 2026 alongside additional AMPLIFY-7P translational findings.
Market context and financial position
Adjuvant PDAC remains one of oncology's most challenging settings. Despite the approval of adjuvant gemcitabine-plus-capecitabine and FOLFIRINOX regimens, five-year survival rates remain low, and no immunotherapy has yet secured a label in this setting. A number of companies, including those pursuing personalised neoantigen vaccines and other KRAS-targeted approaches, are active in the space. Elicio's off-the-shelf AMP platform, which uses albumin-mediated lymph node delivery, is positioned by the company as a scalable alternative to patient-specific manufacturing, though the absence of a Phase 3 readout means that clinical advantage remains unproven.
On the financial side, Elicio reported a net loss of $8.0 million for the third quarter of 2026, down from $10.1 million in the same period a year earlier. Research and development expenditure was broadly flat at $4.9 million. Cash and cash equivalents stood at $30.9 million as at 30 September 2026, supplemented by $4.3 million raised through the company's at-the-market programme during the quarter and approximately $13.6 million from a registered direct offering completed in July 2026. The company said it expects current funds to support operations into the second quarter of 2027, leaving a relatively near-term financing horizon that investors will be monitoring alongside Phase 3 planning milestones.