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Elicio Therapeutics

Company Overview

A clinical-stage biotechnology company developing lymph node-targeted therapeutic cancer vaccines via its Amphiphile platform, with lead asset ELI-002 7P targeting mutant KRAS in adjuvant pancreatic cancer. Elicio's central bet is that directing immunotherapy payloads precisely to lymph nodes — where T cells are trained — can unlock durable anti-tumor responses in one of oncology's most intractable diseases. The company trades on the Nasdaq Global Market under the ticker ELTX.

Headquarters and Global Presence

Elicio Therapeutics is headquartered in Boston, Massachusetts, and operates as a focused clinical-stage entity without a broad international footprint. The company's foundational technology originated in the laboratory of Darrell Irvine, PhD, at MIT.

Founding and History

Elicio was founded in 2011, based on MIT-derived Amphiphile technology from Darrell Irvine's laboratory. The company went public via a reverse merger with Angion Biomedica Corp., which closed on June 1, 2023; shares began trading on Nasdaq under ELTX on June 2, 2023, on a 1-for-10 reverse-split adjusted basis. Phase I data from the AMPLIFY-201 trial were subsequently published in Nature Medicine, establishing the platform's immunological proof of concept in pancreatic and colorectal cancer patients.

Therapy Areas and Focus

Elicio's pipeline centers on adjuvant oncology — specifically patients with KRAS/NRAS-mutated solid tumors who remain at high risk of recurrence after surgical resection. Pancreatic ductal adenocarcinoma (PDAC) is the lead indication; KRAS mutations are present in roughly 88% of PDAC cases, making it a logical anchor for a multi-neoantigen KRAS-directed vaccine. Colorectal cancer has also been explored in earlier studies. The adjuvant setting is strategically chosen: residual disease burden is lowest post-resection, where a vaccine-primed immune response has the best chance of meaningful impact.

Technology Platforms and Modalities

The Amphiphile (AMP) platform is Elicio's core engine. It works by chemically modifying immunotherapeutic payloads — peptides, adjuvants — so they bind to albumin in the bloodstream, hitchhiking to lymphatic tissue where T cell priming occurs. This lymph node targeting is designed to overcome a fundamental limitation of conventional vaccines: most of the antigen never reaches the site where a meaningful immune response is generated. The platform originated at MIT and is applicable across multiple antigen targets beyond KRAS.

Key Pipeline and Programs

ELI-002 7P is Elicio's single clinical-stage asset and the program on which the company's future rests. It is a therapeutic cancer vaccine combining seven KRAS/NRAS mutant peptide antigens — covering the G12D, G12R, G12V, G12C, G12A, G12S, and G13D variants — with an Amphiphile-modified CpG oligonucleotide adjuvant. The mechanism aims to expand polyfunctional mutant KRAS-specific T cells via direct lymph node delivery.

The AMPLIFY-7P trial (NCT05726864) began as a Phase I/II study in KRAS/NRAS-mutated solid tumors in the adjuvant setting. The Phase II randomized portion reported on June 15, 2026, and missed its pre-specified primary endpoint of disease-free survival in the intent-to-treat population — a significant setback. However, a post-hoc analysis of the R0 completely resected subgroup (n=121, roughly 84% of the enrolled population) showed a hazard ratio of 0.65 (p=0.048), with median DFS of 23.8 months versus 12.8 months for observation. Post-hoc landmark analyses at 3 and 6 months showed an approximately 14% absolute DFS benefit during active treatment, and T cell correlations were notably strong (HR 0.22, p<0.0001). ELI-002 7P had a favorable safety profile with no treatment-related discontinuations or deaths. Elicio has outlined a refined Phase III strategy focused on R0 patients with extended dosing, contingent on securing financing.

Recent Developments

On June 15, 2026, Elicio disclosed that the randomized Phase II AMPLIFY-7P study missed its primary DFS endpoint in the intent-to-treat population, sending shares down approximately 73-74% to around $3.92. The company simultaneously outlined a Phase III development strategy for R0 completely resected PDAC patients with extended dosing. As of March 31, 2026, Elicio held $14.9 million in cash and reported a Q1 2026 net loss of $11.8 million; management cited substantial doubt about the company's ability to continue as a going concern, with cash expected to last only into the fourth quarter of 2026.

Key Personnel

Robert Connelly serves as Chief Executive Officer of Elicio Therapeutics. The company's foundational scientific work traces to Darrell Irvine, PhD, of MIT, whose laboratory developed the original Amphiphile technology on which the platform is based.

Strategic Partnerships

Elicio does not have disclosed major commercial partnerships or licensing deals at this stage. The company has indicated it will need additional financing or partnerships to advance ELI-002 7P into Phase III, making a future collaboration or capital raise a near-term strategic necessity.

FAQ Section

The company's rationale rests on the post-hoc R0 subgroup analysis (n=121), which showed a hazard ratio of 0.65 (p=0.048) and a doubling of median DFS from 12.8 to 23.8 months. Post-hoc data are inherently hypothesis-generating rather than confirmatory, but the T cell immunogenicity correlations — HR 0.22, p<0.0001 — suggest a genuine biological signal. Elicio's refined Phase III design, targeting R0 patients with extended dosing, is an attempt to enrich for the population where the vaccine appears to work. Whether regulators and investors accept that framing depends heavily on securing the financing Elicio has acknowledged it does not currently have.

KRAS is the most frequently mutated oncogene in human cancer, and in pancreatic ductal adenocarcinoma the mutation rate reaches roughly 88%. Because these mutations are tumor-specific neoantigens — present in cancer cells but not normal tissue — they offer an attractive immune target with a favorable therapeutic window. Until recently, KRAS was considered undruggable; the emergence of direct KRAS inhibitors and now KRAS-directed vaccines reflects how rapidly the field has moved. ELI-002 7P covers seven of the most common KRAS/NRAS variants, giving it breadth across the patient population.

Conventional peptide vaccines injected subcutaneously distribute broadly in the body, and most antigen never reaches the lymph nodes where T cells are trained and activated. The AMP platform addresses this by chemically tagging payloads so they bind albumin in the blood and are trafficked directly to lymphatic tissue. The result, demonstrated in the Phase I AMPLIFY-201 trial and published in Nature Medicine, is robust induction of mutant KRAS-specific T cells and reductions in tumor biomarkers in post-surgical patients. That immunological potency is the platform's core commercial argument — though translating T cell responses into survival benefit at the trial level has proven harder.

ELI-002 7P is a seven-peptide therapeutic vaccine targeting the most prevalent KRAS/NRAS oncogenic mutations, combined with a lymph node-targeted CpG adjuvant. In the Phase II AMPLIFY-7P randomized study, the vaccine failed to meet its pre-specified primary DFS endpoint in the intent-to-treat population — the trial's defining setback. In the post-hoc R0-resected subgroup, DFS improved from 12.8 to 23.8 months, with no treatment-related discontinuations or deaths, indicating a tolerable safety profile. The open question is whether the Phase III, designed around this subgroup and extended dosing, can replicate the signal in a prospectively defined population.

Elicio's pipeline is currently concentrated on pancreatic ductal adenocarcinoma as the primary indication for ELI-002 7P, but the AMPLIFY-7P protocol was designed to enroll patients with KRAS/NRAS-mutated solid tumors more broadly — including colorectal cancer, which was explored in the earlier Phase I AMPLIFY-201 trial. The AMP platform is mechanistically applicable to any antigen target that benefits from lymph node delivery, though no additional clinical programs beyond ELI-002 7P are currently disclosed. In practice, Elicio's near-term fate is essentially a single-asset, single-indication story.

Elicio is at a critical inflection point: Phase II completed with a primary endpoint miss, a post-hoc Phase III rationale outlined, and a cash runway that extends only into the fourth quarter of 2026 based on Q1 figures. The immediate milestones are securing financing or a partnership to fund Phase III, and reaching alignment with regulators on the refined trial design focused on R0-resected patients. Without additional capital, the Phase III strategy cannot advance — making Elicio's near-term story as much about its balance sheet as its biology.

The Phase II miss leaves Elicio in a precarious position, and several near-term factors will determine whether it can advance:

Financing or partnership: cash lasts only into Q4 2026; any Phase III requires a capital raise or deal, and terms after a 73-74% stock decline will be dilutive.
Regulatory feedback on Phase III design: whether the FDA accepts the R0 post-hoc subgroup as a valid basis for a confirmatory trial is a critical gating question.
Phase III design rigor: the refined study must prospectively define the R0-resected population and incorporate extended dosing — the post-hoc framing invites scientific scrutiny.
Competitive landscape: mRNA-based personalized cancer vaccines (notably mRNA-4157/V940 from Moderna and Merck) and direct KRAS inhibitors are advancing rapidly in overlapping indications.
Going concern status: management has already disclosed substantial doubt about the company's ability to continue operations, which constrains its negotiating leverage with potential partners.

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