Elicio Therapeutics Announces Investigator-Initiated Phase 1 Trial to be Conducted by Memorial Sloan Kettering Cancer Center and funded by The Lustgarten Foundation for Neoadjuvant ELI-002 7P in Pancreatic Ductal Adenocarcinoma

Rhea-AI Summary

Elicio Therapeutics (NASDAQ:ELTX) has announced a significant advancement in pancreatic cancer treatment with a new Phase 1 investigator-initiated trial for their immunotherapy drug ELI-002 7P. The study, led by Memorial Sloan Kettering Cancer Center and funded by the Lustgarten Foundation, will evaluate ELI-002 7P in combination with chemotherapy (mFOLFIRINOX) and an anti-PD1 checkpoint inhibitor.

The trial will focus on borderline and resectable pancreatic ductal adenocarcinoma (PDAC) patients, enrolling 20 patients across two cohorts (10 per arm). The study aims to convert immunologically "cold" tumors to T-cell-inflamed "hot" tumors, potentially improving surgical outcomes and long-term survival. The trial is expected to begin in H1'2026.

Positive

• Novel combination therapy approach targeting the immunosuppressive PDAC tumor microenvironment
• ELI-002 7P has demonstrated robust T-cell responses in multiple trials
• Potential to improve surgical outcomes and long-term survival in PDAC patients
• Support from prestigious institutions (Memorial Sloan Kettering and Lustgarten Foundation)

Negative

• Trial start date is relatively distant (H1'2026)
• Small initial trial size of only 20 patients
• PDAC has historically been refractory to single-agent immune checkpoint inhibitors

Insights

Oncology Clinical Trial Expert

Elicio's new pancreatic cancer trial combines their immunotherapy with standard chemotherapy, potentially improving immune response in a notoriously treatment-resistant cancer.

Elicio Therapeutics has announced a significant advancement in their clinical development program for ELI-002 7P, their novel immunotherapy targeting pancreatic ductal adenocarcinoma (PDAC). The upcoming investigator-initiated Phase 1 trial represents a strategic expansion into the neoadjuvant setting (treatment before surgery), combining ELI-002 7P with standard chemotherapy and potentially an immune checkpoint inhibitor.

The study's design is particularly noteworthy for addressing a critical challenge in pancreatic cancer treatment. PDAC tumors are typically immunologically "cold," meaning they lack sufficient T-cell infiltration and checkpoint expression to respond to immunotherapies alone. By combining mFOLFIRINOX chemotherapy with ELI-002 7P, researchers aim to convert these "cold" tumors into "hot" ones that might respond to checkpoint inhibition.

The trial's dual-cohort structure (with and without anti-PD-1 therapy) across 20 patients will provide valuable comparative data on the optimal combination approach. The partnership with Memorial Sloan Kettering and funding from the Lustgarten Foundation adds credibility to this program.

For context, ELI-002 7P has already demonstrated robust T-cell responses in previous trials, suggesting potential efficacy in modifying the tumor microenvironment. The timing (H1'2026 start) indicates this is a forward-looking development that won't impact near-term financials but could significantly expand Elicio's market opportunity if successful in improving surgical outcomes and survival metrics for resectable PDAC patients.

• Study will evaluate ELI-002 7P in combination with chemotherapy and a checkpoint inhibitor (“CPI”) in the neoadjuvant setting
  
• Trial is anticipated to begin enrolling in H1’2026
  

BOSTON, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced the planned initiation of an investigator-initiated Phase 1 neoadjuvant study of ELI-002 7P in combination with chemotherapy and an anti-PD1 checkpoint inhibitor in borderline and resectable pancreatic ductal adenocarcinoma (“PDAC”). The multi-center investigator-initiated trial (“IIT”) will be led by principal investigator, Kevin Soares, M.D., from Memorial Sloan Kettering Cancer Center (“MSK”), and is being funded by the Lustgarten Foundation.

The IIT will evaluate mFOLFIRINOX in combination with ELI-002 7P, with or without the anti–PD-1 antibody. The study is designed to enroll 20 patients across two cohorts (10 per arm). The trial is expected to commence in H1’2026.

“We are entering an exciting era in pancreatic cancer treatment, where combining standard neoadjuvant chemotherapy with innovative immunotherapies has the potential to offer real hope. PDAC, unfortunately, has remained refractory to single-agent immune checkpoint inhibitors due to low infiltration of T-cells to the tumor site and low PD-1/PD-L1 expression. Targeting the immunosuppressive PDAC tumor microenvironment (“TME”) with ELI-002 7P, which has demonstrated robust T-cell responses in multiple trials, may be able to convert immunologically “cold” tumors to T-cell-inflamed “hot” tumors with upregulation of checkpoint signaling priming disease for treatment with previously ineffective immune checkpoint inhibitors. This trial of mFOLFIRINOX plus ELI-002 7P, with or without anti-PD-1, is designed not just to evaluate efficacy and safety, but to understand deeply how T cells in both the tumor and the periphery respond. Our aim is to improve surgical outcomes and long-term survival by harnessing the immune system in ways we haven’t yet fully explored,” said Dr. Soares.

Chief Medical Officer of Elicio Therapeutics, Christopher Haqq, M.D., Ph.D., added, “We believe this study represents a critical step forward in KRAS-targeted immunotherapy. By evaluating ELI-002 in combination with mFOLFIRINOX and exploring the additional role of anti-PD-1 blockade, we aim to establish a treatment paradigm that maximizes immune activation while maintaining safety. Our hope is that this approach will deliver meaningful improvements in relapse-free survival and overall survival for patients facing resectable and borderline resectable PDAC in the neo-adjuvant setting. If Phase 1 results are supportive, expanding to a broader population in this setting could enable more PDAC patients to benefit from ELI-002 7P, and also enhance the commercial opportunity for Elicio.”

About ELI-002

Elicio’s lead product candidate, ELI-002, is a structurally novel investigational AMP cancer vaccine 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 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 2P (2-peptide formulation) has been studied in the Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). ELI-002 7P (7-peptide formulation) is currently being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002.

About the Amphiphile Platform

Elicio’s proprietary AMP platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. Elicio believes this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, Elicio observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. Elicio believes its AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based on preclinical studies.

Elicio’s AMP platform, originally developed at the Massachusetts Institute of Technology, has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The AMP platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue.

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 successes in the personalized cancer vaccine space to develop effective, off-the-shelf vaccines. Elicio’s Amphiphile (“AMP”) technology aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional vaccination strategies, with the goal of promoting durable cancer immunosurveillance in patients. Elicio’s ELI-002 lead program is an off-the-shelf vaccine candidate targeting the most common KRAS mutations, which drive approximately 25% of all solid tumors. Off-the-shelf vaccine approaches have the potential benefits of low cost, rapid commercial scale manufacturing, and rapid availability of drug to patients especially in neo-adjuvant settings and for prophylaxis in high-risk patients, contrary to personalized vaccines approaches. ELI-002 is being studied in an ongoing, randomized clinical trial in patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. ELI-002 also has been studied in patients with mKRAS-positive colorectal cancer (“CRC”) in Phase 1 studies. The updated AMPLIFY-201 Phase 1 data for PDAC and CRC was presented at the ESMO Immuno-Oncology Congress 2024 and included a 16.3-month median recurrence-free survival and 28.9-month median overall survival for the full study population. In the future, Elicio plans to expand ELI-002 to other indications including mKRAS positive lung cancer and other mKRAS positive cancers. Elicio’s pipeline includes additional off-the-shelf therapeutic cancer vaccines candidates, including ELI-007 and ELI-008, that target BRAF-driven cancers and p53 hotspot mutations, respectively. For more information, please visit www.elicio.com.

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 and the anticipated design of such programs, including the IIT; the timing and outcome of Elicio’s planned clinical trials, including the anticipated commencement of the IIT in the first half of 2026; the potential of Elicio’s product candidates and platform; the potential to improve surgical outcomes and long-term survival by harnessing the immune system; the potential benefits of combining standard neoadjuvant chemotherapy with immunotherapies, including the combination of mFOLFIRINOX with ELI-002 7P, with or without the anti-PD-1 antibody; the potential for the proposed combination to deliver meaningful improvements in relapse-free and overall survival for resectable and borderline resectable PDAC patients in the neo-adjuvant setting; the potential to establish a treatment paradigm; the potential benefits of targeting the immunosuppressive PDAC TME with ELI-002 7P; the potential to expand to a broader population to enable more PDAC patients to benefit from ELI-002 7P and enhance Elicio’s commercial opportunity; 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 our 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 initiation of Elicio’s planned clinical trials, including the IIT, anticipated to begin enrolling in the first half of 2026; 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, 2024, filed with the SEC on March 31, 2025, Elicio’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 13, 2025, and Elicio’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 7, 2025, 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.

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

FAQ

What is the purpose of Elicio Therapeutics' (ELTX) new Phase 1 trial for ELI-002 7P?

The trial aims to evaluate ELI-002 7P in combination with mFOLFIRINOX chemotherapy and an anti-PD1 checkpoint inhibitor for treating borderline and resectable pancreatic ductal adenocarcinoma (PDAC).

How many patients will be enrolled in the ELTX Phase 1 pancreatic cancer trial?

The trial will enroll 20 patients divided into two cohorts of 10 patients each.

When will Elicio Therapeutics begin enrolling patients for the ELI-002 7P Phase 1 trial?

The trial is expected to begin enrolling patients in the first half of 2026.

Who is conducting and funding the Elicio Therapeutics PDAC trial?

The trial will be led by Dr. Kevin Soares at Memorial Sloan Kettering Cancer Center and is being funded by The Lustgarten Foundation.

What makes ELI-002 7P potentially effective for pancreatic cancer treatment?

ELI-002 7P has shown ability to generate robust T-cell responses and may convert immunologically 'cold' tumors to T-cell-inflamed 'hot' tumors, potentially making checkpoint inhibitors more effective.