Elicio Wins ESMO 2026 Oral Slot For Phase 2 Cancer Data

For CMC teams and plant heads tracking KRAS-targeted immunotherapy pipelines, Elicio Therapeutics has secured a late-breaking Proffered Paper oral presentation at ESMO Congress 2026, a designation that signals the oncology community's appetite for the complete AMPLIFY-7P dataset and raises the near-term question of Phase 3 manufacturing scope.

The presentation covers new pre-specified analyses from the randomized Phase 2 AMPLIFY-7P study of ELI-002 7P (camupepimut), a seven-valent mKRAS-specific Amphiphile immunotherapy evaluated against observation in 144 patients with resected pancreatic ductal adenocarcinoma across 24 U.S. clinical sites. The study did not meet its pre-specified primary disease-free survival endpoint in the intent-to-treat population; however, subsequent analyses have generated biological and clinical activity data that Elicio states will inform a refined Phase 3 development strategy in adjuvant PDAC.

The manufacturing relevance is direct. ELI-002 7P is formulated as an off-the-shelf subcutaneous product comprising AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant. Any Phase 3 advancement would require process validation packages aligned with ICH Q10 pharmaceutical quality system expectations and CMC documentation sufficient to support a pivotal IND amendment or BLA filing. The seven-peptide formulation's multi-antigen architecture adds complexity to release testing and comparability protocols that CMC leads should begin scoping now, ahead of data readout.

Eileen M. O'Reilly, M.D., of Memorial Sloan Kettering Cancer Center, will present abstract LBA83 on October 23, 2026, at 13:30 CEST in the Almeria Auditorium, Hall 9, Madrid. The late-breaking abstract becomes publicly available via the ESMO Congress 2026 website at 00:05 CEST on the day of presentation; a session webcast is expected on the ESMO Virtual Platform within 12 hours, subject to presenter permission.

The refined Phase 3 strategy Elicio references will hinge on the subgroup and biomarker analyses presented at ESMO, data points that will directly shape patient selection criteria, dosing regimen, and ultimately the batch size and supply-chain architecture required to support a multi-site pivotal trial in a rare, post-surgical oncology indication.

Source: GlobeNewswire via Elicio Therapeutics press release, September 24, 2026. ESMO Congress 2026 presentation scheduled October 23, 2026, 13:30–15:00 CEST; webcast available on ESMO Virtual Platform within 12 hours post-session.