Elicio Therapeutics Announces Activation of the Investigator-Initiated Phase 1 Study of Neoadjuvant ELI-002 7P for Pancreatic Ductal Adenocarcinoma
Rhea-AI Summary
Elicio Therapeutics (Nasdaq: ELTX) announced activation of an investigator-initiated, randomized, open-label Phase 1 neoadjuvant trial (NCT07671339) of its AMP-based KRAS-targeted immunotherapy ELI-002 7P in resectable and borderline resectable KRAS-mutant pancreatic ductal adenocarcinoma (PDAC). The multi-center study, conducted by Memorial Sloan Kettering Cancer Center and funded by a partnership between The Lustgarten Foundation and Break Through Cancer, aims to enroll 20 patients.
Patients will receive ELI-002 7P with standard neoadjuvant chemotherapy mFOLFIRINOX, with or without the anti-PD1 checkpoint inhibitor tislelizumab, starting before surgery and continuing afterward. The study will collect tumor and blood samples to assess immune activation, tumor microenvironment changes and potential biomarkers to guide future trials. ELI-002 7P, covering seven common KRAS mutations present in about 25% of solid tumors, has previously been evaluated in the Phase 2 AMPLIFY-7P trial in high-risk mKRAS-positive pancreatic cancer, where overall survival data remained immature at the time of analysis. Elicio is also planning additional ELI-002 7P studies in metastatic and adjuvant PDAC and other mKRAS-positive cancers.
Positive
- Phase 1 IIT activated for ELI-002 7P in neoadjuvant KRAS-mutant PDAC with 20 planned patients
- Externally funded trial conducted by MSK and funded by Lustgarten Foundation and Break Through Cancer
- Combination regimen evaluates ELI-002 7P with standard mFOLFIRINOX ± tislelizumab before surgery
- Translational design includes serial tumor and blood sampling to identify immune biomarkers
- Broad KRAS coverage: ELI-002 7P targets seven KRAS mutations present in about 25% of solid tumors
- Phase 2 experience: ELI-002 7P already evaluated in randomized AMPLIFY-7P trial in high-risk pancreatic cancer
Negative
- Early-stage study: current neoadjuvant trial is Phase 1 with only 20 planned patients
- Immature survival data: overall survival from the Phase 2 AMPLIFY-7P trial remained immature at the time of analysis
- Further development needed: Elicio is still refining Phase 3 strategy and planning additional Phase 1 studies
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 15 | Phase 2 trial results | Negative | -72.5% | Phase 2 study missed its primary DFS endpoint; subgroup findings informed revised Phase 3 plans. |
| Dec 11 | Phase 2 immunogenicity data | Positive | +4.0% | Subset analysis showed antigen spreading and broad T-cell responses beyond targeted mKRAS antigens. |
| Nov 07 | Phase 2 immune response | Positive | -2.2% | Updated data reported robust mKRAS-specific T-cell responses across diverse HLA backgrounds. |
| Oct 27 | Phase 2 immune response | Positive | +0.0% | Preliminary results showed mKRAS-specific T-cell responses across diverse HLA backgrounds. |
| Sep 29 | Phase 1 trial announcement | Positive | -1.4% | MSK-led investigator-initiated trial announced with Lustgarten Foundation funding. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-matched clinical-trial news produced mixed reactions, averaging -14.44% across five events, with negative outcomes associated with the largest divergence.
Key Terms
neoadjuvant medical
investigator-initiated regulatory
checkpoint inhibitor medical
tumor microenvironment medical
CpG oligodeoxynucleotide technical
mFOLFIRINOX medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Phase 1 study conducted by Memorial Sloan Kettering (“MSK”) Cancer Center and funded by The Lustgarten Foundation
- Study to evaluate ELI-002 7P in combination with chemotherapy and checkpoint inhibition in the neoadjuvant setting
- Expected to enroll 20 patients with resectable or borderline resectable pancreatic ductal adenocarcinoma (“PDAC”)
BOSTON, Aug. 10, 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 the opening of the investigator-initiated (“IIT”) Phase 1 neoadjuvant study (NCT07671339) evaluating ELI-002 7P in combination with chemotherapy and an anti-PD1 checkpoint inhibitor in borderline resectable and resectable PDAC. The multi-center IIT is being conducted by MSK Cancer Center and is being funded by a strategic partnership between The Lustgarten Foundation and Break Through Cancer.
“The activation of this study marks an important milestone as we prepare to evaluate the potential of ELI-002 7P across multiple stages of pancreatic cancer,” said Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer of Elicio. “Building on the complete responses observed in patients with metastatic PDAC treated with sequential ELI-002 7P followed by checkpoint inhibitor and chemotherapy, this study prospectively evaluates the combination beginning in the neoadjuvant setting and continuing after surgery. We hope to generate important clinical insights into ELI-002 7P’s potential to harness the immune system and improve surgical outcomes and long-term survival for patients facing this devastating disease.”
Kevin Soares, MD, Assistant Attending Surgeon Hepatopancreatobiliary Service, MSK and Principal Investigator of the Phase 1 study added, “Despite advances in the treatment of pancreatic cancer, patients with resectable and borderline resectable disease continue to face a high risk of recurrence, highlighting the need for new therapeutic strategies. This trial offers an important opportunity to investigate how ELI-002 7P may reshape the tumor immune environment when initially combined with neoadjuvant therapy, while offering the potential to generate valuable translational data that could inform future treatment strategies.”
The randomized, open-label Phase 1 trial aims to enroll 20 patients with resectable or borderline resectable KRAS-mutant PDAC. Participants will receive ELI-002 7P with standard chemotherapy, mFOLFIRINOX, with or without tislelizumab, an anti-PD1 checkpoint inhibitor, starting before surgery. Throughout treatment, researchers plan to collect tumor tissue and blood samples to better understand immune activation, characterize changes within the tumor microenvironment, and identify biomarkers that could guide future clinical trials.
About ELI-002
Elicio’s lead product candidate, ELI-002, is a structurally novel investigational AMP cancer immunotherapy that targets cancers that are driven by mutations in the KRAS-gene—a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio’s proprietary AMP technology consisting of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant that is available as an off-the-shelf subcutaneous administration.
ELI-002 7P (7-peptide formulation) was evaluated in the randomized Phase 2 AMPLIFY-7P trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). The Phase 2 AMPLIFY-7P trial included patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. Elicio continues to evaluate pre-specified subgroups, including the R0 resected population, to further inform a refined Phase 3 development strategy. Elicio intends to initiate a Phase 1 study in metastatic PDAC designed to provide a rapid assessment of clinical activity using an open label design to assess the objective response rate including partial and complete radiographic responses. Elicio plans to use the study findings to further evaluate checkpoint inhibitor combinations and help inform future development strategies in metastatic PDAC and the adjuvant PDAC Phase 3 trial. At the time of the Phase 2 AMPLIFY-7P analysis, data for overall survival remained immature. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in
About Elicio Therapeutics
Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing novel immunotherapies for the treatment of high-prevalence 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
About Break Through Cancer
Founded in 2021, Break Through Cancer empowers outstanding researchers and physicians to both intercept and find cures for several of the deadliest cancers by stimulating radical collaboration among outstanding cancer research institutions, including its founding partners: Dana-Farber Cancer Institute, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Memorial Sloan Kettering Cancer Center, MIT’s Koch Institute for Integrative Cancer Research, and The University of Texas MD Anderson Cancer Center.
The Foundation is supported by a Board of Directors from the five partner institutions and a Scientific Advisory Board of U.S. cancer experts. The Foundation was launched with an extraordinary challenge pledge of
For further information, please visit the Foundation’s website at www.breakthroughcancer.org.
About The Lustgarten Foundation
The Lustgarten Foundation is the largest private funder of pancreatic cancer research in the world, funding preeminent pancreatic cancer research, driving the pursuit of bold and innovative science toward earlier detection and better treatments, and transforming pancreatic cancer into a curable disease. The Foundation funds research where creative risks yield high rewards to accelerate and expand life-saving treatment options. The Lustgarten foundation believes time is everything to patients and their families, and that community is power. Lustgarten programs and events provide people affected by pancreatic cancer a voice and a place to create hope, together.
For more information about the Lustgarten Foundation, visit lustgarten.org and follow us on Facebook, Instagram, Bluesky, LinkedIn, and YouTube.
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 Elicio’s planned clinical programs, including the IIT; the timing, enrollment, and outcome of Elicio’s planned clinical trials; the potential of Elicio’s product candidates and platform; the potential to generate important clinical insights into ELI-002 7P’s potential to harness the immune system and improve surgical outcomes and long-term survival for patients with PDAC; the potential benefits of combining standard neoadjuvant chemotherapy with immunotherapies, including the combination of mFOLFIRINOX with ELI-002 7P, with or without tislelizumab; the potential for ELI-002 7P to reshape the tumor immune environment when combined with neoadjuvant therapy; the potential for the IIT to generate valuable translational data to inform future treatment strategies; the potential for future expansion of ELI-002 to other indications, including mKRAS positive lung cancer and other mKRAS positive cancers; the potential benefits and effectiveness of off-the-shelf vaccine 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. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are 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 of data from Elicio’s clinical trials; the timing of any planned investigational new drug application or new drug application; Elicio’s plans to research, develop and commercialize its current and future product candidates; 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, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 11, 2026, and any 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
Elicio Media Contact
Michael Fitzhugh
LifeSci Communications
(415) 269-7757
mfitzhugh@lifescicomms.com
