Elicio Therapeutics to Present Clinical and Preclinical Data at the SITC 2025 Annual Meeting

Rhea-AI Summary

Elicio Therapeutics (Nasdaq: ELTX) will present clinical and preclinical data at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting, Nov 5–9, 2025, in National Harbor, MD.

Two poster presentations include a late-breaking abstract reporting immunogenicity results from the ongoing Phase 2 AMPLIFY-7P trial of ELI-002 in mKRAS-driven pancreatic cancer (Abstract 1317; Nov 7, 2025) and preclinical data for ELI-004 showing AMP-immunomodulator activity in syngeneic solid tumor models (Abstract 946; Nov 8, 2025).

Late-breaking poster presentation to highlight new immunogenicity data from ongoing Phase 2 AMPLIFY-7P trial of ELI-002 in patients with mKRAS-driven pancreatic cancer

BOSTON, Nov. 03, 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 that the Company will present a late-breaking update on clinical immunogenicity results from its ongoing Phase 2 AMPLIFY-7P trial of ELI-002 in patients with mKRAS-driven pancreatic cancer and preclinical data from ELI-004 for the treatment of advanced solid tumors via two accepted poster presentations at the Society for Immunotherapy of Cancer’s (“SITC”) 40^th Anniversary Annual Meeting, taking place November 5–9, 2025, in National Harbor, Maryland.

Presentation Details:

Late-breaking Abstract (“LBA”) Poster Presentation

Title: AMPLIFY-7P Phase 2: T cell responses induced by ELI-002 7P, a lymph node-targeted amphiphile therapeutic cancer vaccine in patients with KRAS mutated pancreatic ductal adenocarcinoma
Presenter: Lisa McNeil, Ph.D., Vice President, Translational Medicine at Elicio
Abstract Number: 1317
Session Date: Friday, Nov. 7, 2025
Location: Prince George ABC Exhibit Halls – Gaylord National Resort and Convention

Poster Presentation

Title: Amphiphile (AMP)-Immunomodulator therapy controls growth and eradicates syngeneic solid tumors
Presenter: Martin Steinbuck, Ph.D., Director of Research at Elicio
Abstract Number: 946
Session Date: Saturday, Nov. 8, 2025
Location: Prince George ABC Exhibit Halls – Gaylord National Resort and Convention

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 successes in the personalized cancer immunotherapy space to develop effective, off-the-shelf immunotherapies. Elicio’s Amphiphile (“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 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 neo-adjuvant settings and for prophylaxis in high-risk patients, contrary to personalized immunotherapy 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 immunotherapy 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.

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 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 ELI-004

ELI-004 is a structurally novel, investigational AMP-modified immune-stimulatory CpG oligonucleotide. CpG oligonucleotide sequences are potent stimulators of TLR-9 which induce activation of innate immune cells, and production of supportive inflammatory effector molecules critical for enhancing innate and adaptive immunity. AMP-modification of CpG oligonucleotides promotes several mechanisms which may enhance tumor-directed immune responses: as an adjuvant administered with an antigen to the peripheral tissue, association with tissue albumin promotes delivery from the injection site to the lymph nodes where targeted uptake can enhance action on key immune cells which promote anti-tumor activity; following local injection into a solid tumor, AMP-mediated retention of CpG sequences concentrates immune activation within the target tumor, likely restricting systemic dissemination to irrelevant or toxicity-inducing sites throughout the body.

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.

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 planned clinical trials; the potential of Elicio’s product candidates and platform; the potential for future expansion of ELI-002 to other indications; the potential benefits and effectiveness of off-the-shelf immunotherapy approaches; the potential participation and presentation at upcoming conferences and medical meetings; 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; 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

When will Elicio Therapeutics (ELTX) present AMPLIFY-7P Phase 2 immunogenicity data at SITC 2025?

The late-breaking AMPLIFY-7P poster (Abstract 1317) is scheduled for Friday, Nov 7, 2025 at the SITC annual meeting.

What data will Elicio (ELTX) present about ELI-002 at SITC 2025?

Elicio will present late-breaking immunogenicity results from the ongoing Phase 2 AMPLIFY-7P trial of ELI-002 in mKRAS-driven pancreatic cancer.

When and where is Elicio presenting preclinical ELI-004 data at SITC 2025?

The ELI-004 preclinical poster (Abstract 946) is scheduled for Saturday, Nov 8, 2025 in Prince George ABC Exhibit Halls at Gaylord National.

Who are the presenters for Elicio's SITC 2025 posters (ELTX)?

Presenters are Lisa McNeil, Ph.D. for the AMPLIFY-7P late-breaking poster and Martin Steinbuck, Ph.D. for the ELI-004 preclinical poster.

What is the focus of the AMPLIFY-7P poster from Elicio (ELTX)?

The AMPLIFY-7P poster focuses on T cell responses induced by the lymph node-targeted amphiphile therapeutic vaccine ELI-002 in KRAS-mutated pancreatic ductal adenocarcinoma.