Elicio Therapeutics Reports Antigen Spreading to Patient-Specific Neoantigens Beyond mKRAS in Ongoing Phase 2 AMPLIFY-7P Trial

• Antigen spreading was evaluated in a subset of Phase 2 patients to assess the ability of ELI-002 7P to broaden immune responses to personalized tumor neoantigens not present in the targeted immunotherapy
• 87% (13/15) of evaluated patients demonstrated induction of T cell responses to tumor neoantigens beyond mKRAS following ELI-002 7P therapy
• The induction of non-mKRAS antigen-specific T cell responses supports the potential for ELI-002 7P to generate a broader, more adaptable, and personalized anti-tumor response
  
  

BOSTON, Dec. 11, 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 analysis of a subset of patients in the ongoing Phase 2 AMPLIFY-7P trial has demonstrated that a majority of evaluated patients (13 out of 15) treated with ELI-002 7P induced antigen spreading targeting non-mKRAS neoantigens that are not present in the ELI-002 7P targeted immunotherapy. Consistent with prior observations in Phase 1, treatment with ELI-002 7P in these evaluated patients resulted in T cell responses targeting personalized tumor antigens in addition to responses directed at the driver mKRAS antigens included in the therapy.

Antigen spreading (also known as epitope spreading) refers to the expansion of the immune response from the initial target antigen(s) to new secondary tumor-specific antigens. This process can occur during treatment with immunotherapy as tumor cells are killed, releasing tumor antigens which can subsequently be targeted by the immune response. The broader multi-targeted immunity which results from antigen spreading may limit the potential for tumors to evade immune responses, leading to more durable responses.

Among 90 evaluable patients treated with ELI-002 7P, 15 patients were selected for antigen spreading analyses based on availability of sufficient blood samples and tumor sequencing data. Direct ex vivo Fluorospot and intracellular cytokine staining assay were conducted on 5-12 tumor neoantigens per patient. Eighty-seven percent (13/15) of evaluated patients demonstrated significant expansion of T cells specific for non-mKRAS tumor neoantigens. Responses were observed to additional common tumor driver mutations as well as personalized neoantigens. The induction of broad T cell responses targeting mKRAS, alongside other personalized tumor antigens, may contribute to more robust anti-tumor immunity, including the potential to prevent relapse.

Robert Connelly, Chief Executive Officer of Elicio, commented, "We are extremely pleased to observe induction of personalized neoantigen-specific T cell responses in a significant majority of assessed Phase 2 patients, suggesting that ELI-002 7P, Elicio's off-the-shelf targeted immunotherapy candidate, has the potential to generate broad tumor-specific immunity targeting both driver mKRAS antigens and personalized neoantigens. These findings are consistent with our prior Phase 1 findings and further strengthen the robust immunogenicity and HLA data we have previously shared for our Phase 2 trial. Induction of broad anti-tumor immunity may enhance the effectiveness of ELI-002 7P by expanding immune recognition across combinations of tumor antigens, supporting more personalized and durable clinical responses."

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 drives 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 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 pre-clinical 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 the timing and outcome of planned clinical trials; the potential of Elicio's product candidates, including the potential for ELI-002 7P to generate broad tumor-specific immunity targeting both driver mKRAS antigens and personalized neoantigens; the potential of ELI-002 7P's induction of broad T cell responses to contribute to more robust anti-tumor immunity, including the potential to prevent relapse; the potential that the induction of broad anti-tumor immunity may enhance the effectiveness of ELI-002 7P, which may support more personalized and durable clinical responses; the potential for future expansion of ELI-002 to other indications, including in mKRAS positive lung cancer and other mKRAS positive cancers; 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 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 7P; 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, Elicio's Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 7, 2025, and Elicio's Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 13, 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

[email protected]