Elicio Therapeutics Announces Late-Breaking Phase 2 AMPLIFY-7P Data Selected for Proffered Paper Oral Presentation at ESMO Congress 2026

AMPLIFY-7P missed its primary disease-free survival endpoint, while additional prespecified analyses are slated for presentation.

Rhea-AI Summary

Elicio Therapeutics (ELTX) will present new Phase 2 AMPLIFY-7P analyses at ESMO Congress on October 23, 2026.

The randomized study compared investigational ELI-002 7P with observation in patients with KRAS-mutated pancreatic ductal adenocarcinoma after standard therapy. It enrolled 144 patients at 24 U.S. sites and did not meet its prespecified primary disease-free survival endpoint in the intent-to-treat population. The presentation will cover new prespecified analyses. Elicio expects the findings to inform its planning for a potential Phase 3 study in pancreatic cancer after surgery.

The late-breaking presentation is scheduled for October 23 in Madrid. Abstract LBA83 will be available on the ESMO Congress website beginning at 00:05 CEST that day. A session webcast is subject to presenter permission and, if permitted, will be available on the congress’s virtual platform within 12 hours after the session.

Key Terms

pdac, disease-free survival, intent-to-treat, cpg oligodeoxynucleotide

4 terms

pdac medical

"resected pancreatic ductal adenocarcinoma (“PDAC”)"

PDAC stands for pancreatic ductal adenocarcinoma, the most common and aggressive form of pancreatic cancer that starts in the pancreas’s duct cells. It matters to investors because PDAC represents a large unmet medical need with high patient mortality, driving intense drug development, clinical trial activity and potential regulatory milestones—like a critical, hard-to-fix engine part whose failure creates urgent demand for effective solutions, affecting a company’s valuation and risk profile.

disease-free survival medical

"pre-specified primary disease-free survival (“DFS”) endpoint"

Disease-free survival measures the length of time after treatment during which a patient shows no signs or symptoms of the disease. For investors, it is a key clinical result because longer disease-free periods suggest a therapy is effective at preventing recurrence, which can drive regulatory approval, market demand and revenue potential—think of it as how long a repaired item runs without breaking down.

intent-to-treat medical

"in the intent-to-treat population"

A method for analyzing clinical trial results that counts every participant in the group they were originally assigned to, regardless of whether they completed the treatment or followed instructions. Like grading a class by the seats students were assigned rather than who finished the exam, it preserves the trial’s original comparisons and gives a realistic, often more conservative, estimate of how a drug or device performs in real-world use — information investors use to judge reliability and regulatory risk.

cpg oligodeoxynucleotide medical

"an AMP-modified CpG oligodeoxynucleotide adjuvant"

Short synthetic DNA fragments that contain unmethylated 'CpG' letter pairs which trigger an immune sensor called Toll-like receptor 9, stimulating innate and adaptive immune responses. They matter to investors because they are a specific type of therapeutic or vaccine ingredient that can boost immune activity like a biological alarm bell, affecting clinical trial design, regulatory review, manufacturing complexity, safety profiles, and potential commercial value of drug or vaccine candidates.

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• New pre-specified analyses from the randomized Phase 2 study will further characterize the clinical potential of ELI-002 7P (camupepimut) in adjuvant pancreatic cancer
• Findings are expected to inform a refined Phase 3 development strategy

BOSTON, Sept. 24, 2026 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX) (“Elicio” or the “Company”), a clinical-stage biotechnology company developing next-generation immunotherapies for KRAS-driven cancers, today announced that new pre-specified analyses from the randomized Phase 2 AMPLIFY-7P study of ELI-002 7P in resected pancreatic ductal adenocarcinoma (“PDAC”) have been selected for a late-breaking Proffered Paper oral presentation at the European Society for Medical Oncology (“ESMO”) Congress 2026, being held October 23–27, 2026, in Madrid, Spain.

“We are pleased to share the complete AMPLIFY-7P results, including new late-breaking analyses, with the global oncology community at ESMO Congress 2026,” said Robert Connelly, President and Chief Executive Officer of Elicio. “These findings deepen our understanding of ELI-002 7P’s clinical and biological activity and provide important direction as we refine the development strategy for a potential Phase 3 study in adjuvant pancreatic cancer.”

Proffered Paper Presentation Details

Abstract Number: LBA83
Title: Seven-Valent mKRAS-specific Lymph Node Targeted Amphiphile Immunotherapy Versus Observation in Resected Pancreatic Ductal Adenocarcinoma (PDAC): the AMPLIFY-7P randomized Phase 2 study
Presenter: Eileen M. O’Reilly, M.D., Memorial Sloan Kettering Cancer Center
Date and Time: October 23, 2026, 13:30-15:00 PM, CEST / 7.30-9 AM EST
Location: Almeria Auditorium- Hall 9

The late-breaking abstract will be available via the ESMO Congress 2026 website beginning at 00:05 CEST on October 23, 2026, the day of the presentation. Subject to presenter permission, a webcast of the session will be available on ESMO Congress 2026 Virtual Platform within 12 hours following the session.

About the AMPLIFY-7P Phase 2 Study

AMPLIFY-7P is a randomized Phase 2 study evaluating ELI-002 7P versus observation in patients with mKRAS-driven PDAC following completion of standard therapy. The study enrolled 144 patients across 24 U.S. clinical sites.

While the study did not meet its pre-specified primary disease-free survival (“DFS”) endpoint in the intent-to-treat population, subsequent analyses have provided important insights into the clinical and biological activity of ELI-002 7P and informed the Company’s continued evaluation of the program.

At ESMO Congress 2026, Elicio will present new pre-specified analyses from AMPLIFY-7P that provide additional insights into the potential clinical benefit of ELI-002 7P and are expected to further inform the Company’s refined Phase 3 development strategy in adjuvant pancreatic cancer.

About ELI-002

Elicio’s lead product candidate, ELI-002, is a structurally novel investigational Amphiphile (“AMP”) cancer immunotherapy that targets cancers driven by mutations in the KRAS gene, a prevalent driver of many human cancers. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant, and is available as an off-the-shelf subcutaneous administration.

ELI-002 7P, the seven-peptide formulation, was evaluated in the randomized Phase 2 AMPLIFY-7P trial in patients with mKRAS-driven pancreatic cancer. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present across multiple solid tumors.

About Elicio Therapeutics

Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing next-generation immunotherapies for the treatment of KRAS-driven cancers, including mKRAS-positive pancreatic and colorectal cancers. Elicio intends to build on recent clinical findings in the personalized cancer immunotherapy space to develop effective, off-the-shelf immunotherapies.

Elicio’s AMP technology aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional immunotherapy strategies, with the goal of promoting durable cancer immunosurveillance in patients. Elicio’s ELI-002 7P lead program is an off-the-shelf immunotherapy candidate targeting the most common KRAS mutations, which drive approximately 25% of all solid tumors.

Off-the-shelf immunotherapy approaches have the potential benefits of low cost, rapid, commercial-scale manufacturing and rapid availability of drug to patients, especially in neoadjuvant settings and for prophylaxis in high-risk patients, contrary to personalized immunotherapy approaches.

Elicio’s pipeline includes additional off-the-shelf therapeutic cancer immunotherapy candidates, including ELI-007 and ELI-008, which target BRAF-driven cancers and p53 hotspot mutations, respectively.

For more information, please visit www.elicio.com.

Elicio Cautionary Note on Forward-Looking Statements

Certain statements contained in this communication regarding matters that are not historical facts are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA.

These include statements regarding the timing and content of Elicio’s presentation at ESMO Congress 2026; the clinical activity, therapeutic potential and potential benefits of ELI-002 7P; the interpretation and potential implications of results and analyses from the AMPLIFY-7P study; the potential for new pre-specified analyses to further characterize the clinical activity of ELI-002 7P; the potential for such analyses and the totality of AMPLIFY-7P findings to inform or support a refined Phase 3 development strategy; the potential benefits and effectiveness of off-the-shelf immunotherapy approaches; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future and, therefore, you are cautioned not to place undue reliance on them.

No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Elicio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law.

Elicio uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify forward-looking statements intended to be covered by the safe-harbor provisions of the PSLRA.

Such forward-looking statements are based on Elicio’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, Elicio’s plans to develop and commercialize its product candidates, including ELI-002; the timing of the availability and presentation of data from Elicio’s clinical trials; Elicio’s plans to research, develop and commercialize its current and future product candidates; the design and timing of future clinical trials; and Elicio’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time to time, and it is not possible for Elicio to predict all such factors, nor can Elicio assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

These risks are more fully discussed under the heading “Risk Factors” in Elicio’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 12, 2026, as amended on April 29, 2026, and Elicio’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 11, 2026, and Elicio’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on August 13, 2026 , as updated by subsequent reports and other documents filed from time to time with the SEC.

Forward-looking statements included in this release are based on information available to Elicio as of the date of this release. Elicio does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this release, except to the extent required by law.

Elicio Investor Relations Contact

Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com

FAQ

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Did Elicio Therapeutics’ AMPLIFY-7P Phase 2 trial meet its primary endpoint?

No. The randomized study did not meet its prespecified primary disease-free survival endpoint in the intent-to-treat population. It enrolled 144 patients across 24 U.S. clinical sites and compared ELI-002 7P with observation after standard therapy.

How can readers access Elicio Therapeutics’ AMPLIFY-7P presentation materials?

Abstract LBA83 will be available on the ESMO Congress 2026 website beginning at 00:05 CEST on October 23, 2026. Subject to presenter permission, a webcast of the session will be available on the congress’s virtual platform within 12 hours after the session.