Elicio Therapeutics Presents Late-Breaking Phase 2 AMPLIFY-7P Results at ESMO Congress 2026 and Announces Simultaneous Publication in Nature Medicine

Subgroup findings favored camupepimut, but a potential Phase 3 design remains subject to regulatory discussion and further planning.

Rhea-AI Summary

Elicio Therapeutics (ELTX) reported that camupepimut missed the primary disease-free survival endpoint in its randomized Phase 2 pancreatic cancer study. AMPLIFY-7P enrolled 144 patients; the overall hazard ratio, a comparison of event risk, was 0.85. Results were presented at ESMO Congress 2026 and published in Nature Medicine.

Pre-specified subgroups favored treatment: hazard ratios were 0.51 without detectable baseline circulating tumor DNA (ctDNA), 0.57 with detectable ctDNA and 0.59 without prior radiation. Baseline ctDNA positivity was more common with treatment than observation, 20.8% versus 12.5%; a model adjusting for baseline factors estimated a treatment-associated hazard ratio of 0.47. Elicio plans FDA discussions about a potential Phase 3 study, including patient selection, treatment duration and combinations. Future design remains subject to regulatory discussion and development planning.

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1 major · 4 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Minor pointBaseline ctDNA-negative subgroup: median disease-free survival not reached versus 21.2 months; HR 0.51, nominal p=0.0280.
• Minor pointBaseline ctDNA-positive subgroup: median disease-free survival 4.3 versus 1.9 months; HR 0.57, nominal p=0.0489.
• Minor pointNo-prior-radiation subgroup: median disease-free survival 23.8 versus 10.4 months; HR 0.59, nominal p=0.0221.
• Minor pointBaseline-adjusted model associated treatment with lower recurrence risk: adjusted HR 0.47; p=0.0086.
• Minor pointSix-month disease-free survival was 75.7% versus 61.7% with observation, a 14.0 percentage-point difference.

9 minor points

• Minor pointMutant KRAS-specific T-cell responses occurred in 99% of evaluable treated patients; median increase was 44.3-fold.
• Minor pointBoth CD4 and CD8 immune responses developed in 85% of patients evaluated for T-cell subsets.
• Minor pointImmune responses persisted at least 46 weeks from baseline in 95.5% of evaluable treated patients.
• Minor pointResponses to additional tumor targets appeared in 13 of 15 patients in a selected subset.
• Minor pointExploratory analysis linked above-threshold immune responses to longer disease-free survival: HR 0.22; nominal p.
• Minor pointGrade 3 or higher adverse events occurred in 10.4% versus 14.6% under observation.
• Minor pointSerious adverse events occurred in 6.3% versus 8.3% under observation.
• Minor pointSafety findings showed no new signals and no adverse events causing study-medication withdrawal.
• Minor point. Forward-looking: it has not happened yet and may not happen.Elicio plans FDA discussions to inform a potential Phase 3 study in adjuvant pancreatic cancer.

Negative

• Major pointPrimary disease-free survival endpoint was not met in the intent-to-treat population; HR 0.85.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Potential Phase 3 design remains subject to regulatory discussion and further development planning.
• Minor pointBaseline ctDNA positivity was imbalanced: 20.8% with camupepimut versus 12.5% with observation.
• Minor pointPrior radiation predicted lower baseline lymphocyte counts and reduced camupepimut-induced mutant KRAS T-cell responses.

News Explained

The release also reports mutant KRAS-specific T-cell responses in 99% of evaluable treated patients; in an exploratory analysis, the 82% above a response threshold had median disease-free survival not reached versus 6.08 months below it (HR 0.22).

Key Figures

Primary ITT DFS endpoint: HR 0.85 DFS, ctDNA-negative subgroup: Not reached vs. 21.2 months; HR 0.51; nominal p=0.0280 DFS, ctDNA-positive subgroup: 4.3 vs. 1.9 months; HR 0.57; nominal p=0.0489 +5 more

Primary ITT DFS endpoint

HR 0.85

Prespecified intent-to-treat primary endpoint was not met

DFS, ctDNA-negative subgroup

Not reached vs. 21.2 months; HR 0.51; nominal p=0.0280

Camూపepimut vs. observation

DFS, ctDNA-positive subgroup

4.3 vs. 1.9 months; HR 0.57; nominal p=0.0489

Camupепimut vs. observation

DFS, no prior radiation

23.8 vs. 10.4 months; HR 0.59; nominal p=0.0221

Camupепimut vs. observation

Adjusted recurrence-risk association

Adjusted HR 0.47; p=0.0086

Multivariable model adjusting for baseline factors

Baseline ctDNA-positive patients

20.8% vs. 12.5%

Camupепimut arm vs. observation arm

Mutant KRAS-specific T-cell response

99%; median 44.3-fold increase from baseline

Evaluable treated patients

Grade 3 or higher adverse events

10.4% vs. 14.6%

Camupепimut vs. observation

Previous Clinical trial Reports

2 past events · Latest: Jun 15

Same Type 2 events

1. Jun 15

   Phase 2 results

   24h Move

   -72.5%

   Earlier AMPLIFY-7P report said the ITT primary DFS endpoint was missed and described post-hoc R0 findings.

2. Dec 11

   Immune response data

   24h Move

   +4.0%

   AMPLIFY-7P subset reported mKRAS T-cell responses and antigen spreading beyond targeted antigens.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

ctDNA, disease-free survival, intent-to-treat, adjuvant

4 terms

ctDNA medical

"patients with and without detectable baseline ctDNA"

Circulating tumor DNA (ctDNA) is tiny fragments of genetic material shed by cancer cells into the bloodstream, like breadcrumbs that can reveal a tumor’s presence and genetic makeup without needing a biopsy. For investors, ctDNA matters because tests and technologies that detect and analyze these fragments can speed diagnosis, track treatment response, and signal relapse, creating commercial opportunities in diagnostics, personalized therapies, and monitoring services.

disease-free survival medical

"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 technical

"intent-to-treat (“ITT”) 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.

adjuvant medical

"potential Phase 3 study in adjuvant pancreatic cancer"

An adjuvant is an ingredient added to a vaccine or other therapy to strengthen or shape the body’s response to the main active component, like a helper that makes the primary ingredient work better or longer. For investors, adjuvants matter because they can change how well a product performs, alter dosing and safety profiles, affect regulatory review, and therefore influence clinical success, market size and competitive advantage.

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• Multiple pre-specified subgroup analyses favored camupepimut (ELI-002 7P), including patients with and without detectable baseline ctDNA.
• Encouraging disease-free survival outcomes were observed in both ctDNA-negative (HR 0.51) and ctDNA-positive (HR 0.57) patients.
• Baseline prognostic imbalances provide important context for the intent-to-treat results, including a 53% lower risk of recurrence or death with camupepimut (multivariable adjusted HR 0.47; p=0.0086).
• Integrated clinical and translational findings provide clear direction for refining patient stratification, optimizing dosing and advancing Phase 3 development.

BOSTON, Oct. 23, 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 results from the randomized Phase 2 AMPLIFY-7P study of camupepimut (ELI-002 7P), presented in a late-breaking Proffered Paper oral session at the European Society for Medical Oncology (“ESMO”) Congress 2026 in Madrid, Spain, and simultaneously published in Nature Medicine: "Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic cancer: the randomized phase 2 AMPLIFY-7P trial".

Across multiple pre-specified analyses, camupepimut demonstrated consistent and favorable treatment-effect trends in patients with and without detectable baseline ctDNA and in patients without prior radiation. While the study did not meet its pre-specified primary disease-free survival (“DFS”) endpoint in the intent-to-treat (“ITT”) population (HR 0.85), the results should be considered in the context of a baseline imbalance in ctDNA positivity, a strong predictor of recurrence, which was more prevalent in the camupepimut arm (20.8% vs. 12.5%). Translational analyses also demonstrated broad, persistent mutant KRAS-specific T-cell responses associated with longer DFS. Together, these findings inform a refined Phase 3 development strategy.

“The AMPLIFY-7P results provide important new insights into camupepimut’s clinical activity and reinforce our confidence in its potential for patients with pancreatic cancer,” said Robert Connelly, President and Chief Executive Officer of Elicio. “We are encouraged by the consistent treatment-effect trends across pre-specified patient groups, including patients with and without detectable baseline ctDNA, and by the strong mKRAS-specific immune responses associated with clinical outcomes. These insights give us clear direction for our potential Phase 3 strategy.”

Pre-Specified Analyses Show Consistent Treatment-Effect Direction Across Baseline ctDNA Subgroups

• In the 93 patients with baseline ctDNA-negative status, median DFS was not reached in the camupepimut arm vs. 21.2 months in the observation arm (HR 0.51; nominal p=0.0280). Recurrence or death was observed in 27.4% (17/62) of camupepimut-treated patients vs. 48.4% (15/31) of patients in observation.
• A consistent treatment effect was also observed in the smaller, higher-risk baseline ctDNA-positive subgroup (n=26). Median DFS was 4.3 months with camupepimut vs. 1.9 months with observation (HR 0.57; nominal p=0.0489).
• Prior radiation predicted lower baseline lymphocyte counts and reduced camupepimut-induced mKRAS T cell responses. In pre-specified analysis, patients who had not received prior radiation (n=106) had median DFS of 23.8 months with camupepimut vs. 10.4 months with observation (HR 0.59; nominal p=0.0221).
  
  

Pre-specified Subgroup	Arm	N	Median DFS	HR, p-value
ctDNA negative	Camupepimut	62	Not Reached	HR 0.51
	Observation	31	21.2 Months	P=0.0280
ctDNA positive	Camupepimut	20	4.3 Months	HR 0.57
	Observation	6	1.9 Months	P=0.0489
No Prior Radiation	Camupepimut	73	23.8 Months	HR 0.59
	Observation	33	10.4 Months	P=0.0221

Baseline Prognostic Imbalance Provides Important Context for ITT Results

• Baseline ctDNA status emerged as a particularly strong prognostic marker. In a pooled analysis across treatment groups, median DFS was 4.2 months for ctDNA-positive patients versus 24.0 months for ctDNA-negative patients (HR 6.56; nominal p<0.000001). Patients with baseline ctDNA positivity were more prevalent in the camupepimut arm (20.8%; 20/96) than in the observation arm (12.5%; 6/48).
• A multivariable model adjusting for baseline factors estimated an association between camupepimut treatment and lower recurrence risk (adjusted HR 0.47; p=0.0086), while elevated CA19-9 (adjusted HR 3.16; p<0.0001) and positive baseline ctDNA (adjusted HR 5.99; p<0.0001) were associated with higher risk.

Early DFS Separation and Immune Findings Support Further Evaluation

• Six-month DFS was 75.7% with camupepimut vs. 61.7% with observation, a 14.0 percentage-point difference immediately following the treatment period supports evaluating treatment duration in future studies.
• Camupepimut induced mutant KRAS-specific T-cell responses in 99% of evaluable treated patients (median 44.3-fold increase from baseline. Among patients evaluated for T-cell subsets, 85% generated both CD4 and CD8 responses. Responses persisted at least 46 weeks from baseline in 95.5% of evaluable treated patients; 13 of 15 patients in a selected subset showed responses to additional tumor targets.
• In an exploratory analysis, stronger camupepimut-induced mutant KRAS-specific T-cell responses were associated with significantly longer DFS. Median DFS was not reached among patients with immune responses above a previously identified threshold (82%, 74/90) vs. 6.08 months among those below the threshold (HR 0.22; nominal p<0.0001).
  

Generally Well-Tolerated Safety Profile

• Camupepimut was generally well tolerated, with no new safety signals observed. Grade 3 or higher adverse events occurred in 10.4% of patients receiving camupepimut vs. 14.6% under observation; serious adverse events occurred in 6.3% and 8.3%, respectively. No adverse events led to withdrawal of study medication.
  

“The Phase 2 translational findings build on and reinforce our Phase 1 observations, demonstrating that camupepimut generates broad and persistent mutant KRAS-specific T-cell responses, with stronger immune responses associated with longer DFS,” said Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer of Elicio. “These observations across both baseline ctDNA subgroups and camupepimut’s favorable safety and tolerability profile provide a strong scientific and clinical rationale for a refined Phase 3 design incorporating optimized patient stratification, extended treatment duration and potential combination approaches.”

Implications for Further Development

Elicio plans to discuss the totality of AMPLIFY-7P findings with the U.S. Food and Drug Administration to inform a potential Phase 3 study in adjuvant pancreatic cancer. Areas for consideration include baseline ctDNA and other prognostic factors in stratification and patient selection, treatment duration, and combination strategies intended to deepen or sustain mutant KRAS-specific immune activity. Any future study design remains subject to regulatory discussion and further development planning.

About the AMPLIFY-7P Phase 2 Study

AMPLIFY-7P Phase 2 is a randomized study evaluating camupepimut versus observation in patients with mutant KRAS-driven pancreatic ductal adenocarcinoma following completion of standard locoregional therapy. The study enrolled 144 patients across 24 U.S. clinical sites.

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.

Camupepimut (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 camupepimut (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 camupepimut (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 camupepimut; 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, 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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Did Elicio's Phase 2 AMPLIFY-7P trial meet its primary endpoint?

No. AMPLIFY-7P did not meet its pre-specified primary disease-free survival endpoint in the intent-to-treat population, with a hazard ratio of 0.85. Pre-specified subgroup analyses favored camupepimut in patients with and without detectable baseline circulating tumor DNA and in patients without prior radiation.

What did Elicio's AMPLIFY-7P trial show in patients without detectable baseline ctDNA?

Among 93 patients without detectable baseline circulating tumor DNA, median disease-free survival was not reached with camupepimut versus 21.2 months with observation. The hazard ratio was 0.51, with nominal p=0.0280. Recurrence or death occurred in 27.4% (17/62) of treated patients versus 48.4% (15/31) under observation.

What safety results did Elicio report for camupepimut in AMPLIFY-7P?

No new safety signals were observed, and no adverse events led to withdrawal of study medication. Grade 3 or higher adverse events occurred in 10.4% of camupepimut patients versus 14.6% under observation. Serious adverse events occurred in 6.3% and 8.3%, respectively.

How were immune responses associated with disease-free survival in Elicio's AMPLIFY-7P trial?

An exploratory analysis associated stronger mutant KRAS-specific T-cell responses with longer disease-free survival. Median disease-free survival was not reached among patients above a previously identified response threshold, representing 82% (74/90), versus 6.08 months among those below it. The hazard ratio was 0.22, with nominal p<0.0001.