Elicio Therapeutics Reports Robust, Cytolytic mKRAS-Specific T Cell Responses Across Diverse Patient HLA in Ongoing Phase 2 AMPLIFY-7P Trial of ELI-002 7P and New ELI-004 Preclinical Data at SITC

Rhea-AI Summary

Elicio Therapeutics (Nasdaq: ELTX) reported updated immunogenicity from the Phase 2 AMPLIFY-7P trial of ELI-002 7P and preclinical intratumoral data for ELI-004 presented at SITC (Nov 7, 2025).

Key clinical highlights: 99% of 90 evaluable patients mounted mKRAS-specific T cell responses (mean 145-fold increase), 86.8% (66/76) induced cytotoxic responses, 85% showed combined CD4/CD8 activation, and 88% responded to their own tumor mutation. HLA typing across 89 patients found 1,132 unique alleles with no clear HLA-specific loss of response. Preclinical ELI-004 intratumoral dosing eradicated tumors in >90% of mice and conferred long-term protection.

Positive

• 99% responder rate in 90 evaluable patients
• Mean 145-fold T cell increase over baseline
• >90% tumor eradication in intratumoral ELI-004 mouse studies

Negative

• Company remains blinded to clinical efficacy and survival correlations
• Most immunogenicity percentages based on partial denominators (e.g., 66/76, 57/76) not full intent-to-treat cohort

Insights

Translational Immunology Analyst

Robust, broad T‑cell immunogenicity reported but clinical efficacy remains unreported and the Company is blinded to outcomes.

ELI-002 7P elicits strong, multi-epitope mKRAS‑specific T cell responses in treated patients, with a reported 99% responder rate (89/90), a mean 145-fold T cell increase, combined CD4/CD8 activation in 85 of patients, and cytolytic responses in 86.8 (66/76). High‑resolution HLA typing showed 1,132 unique alleles and no clear HLA restriction in responders, supporting broad immunogenic reach across diverse genetic backgrounds.

The signal is an immunology readout, not a clinical endpoint. The Company remains blinded to efficacy and any correlation between T cell measures and antitumor benefit. Key dependencies include translation of these immune responses into durable clinical outcomes and confirmation that cytotoxicity associates with disease control. Preclinical ELI‑004 intratumoral data show >90 eradication in mice, but murine cure rates do not prove human efficacy.

Watch for the event‑driven final disease‑free survival analysis and any disclosed correlations between T cell metrics and clinical endpoints; expect such updates to appear after immune‑efficacy unblinding and at upcoming conferences following Nov. 7-8, 2025. Given the current facts, the immunogenicity data are encouraging biologically, but they do not by themselves establish clinical benefit, so the near‑term investment impact is neutral.

• SITC abstracts highlight updated immunogenicity results from the Phase 2 AMPLIFY-7P trial of ELI-002 7P and preclinical data on the use of intratumoral ELI-004 (AMP-CpG) for solid tumor immunotherapy
• ELI-002 7P induced mKRAS-specific T cell responses in 99% of evaluable patients (89/90), demonstrating potent and consistent immune activation
• Robust immune responses were elicited across all seven mKRAS antigens, with >80% response rate to each individual KRAS mutation and 88% of patients generating responses to their own tumor-specific mutation
• 86.8% (66/76) of patients induced cytotoxic mKRAS-specific T cell responses; 75% (57/76) induced CD8⁺ T cells and 75% (57/76) induced CD4⁺ T cells
• mKRAS-specific T cell responses were observed across diverse HLA types, supporting the potential applicability of ELI-002 7P across a broad and genetically diverse patient population
  

BOSTON, Nov. 07, 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 additional immunogenicity data from the ongoing Phase 2 AMPLIFY-7P trial evaluating ELI-002 7P in patients with mKRAS pancreatic ductal adenocarcinoma (“PDAC”) and new preclinical data on immunotherapy candidate ELI-004, for treatment of solid tumors.

The data will be presented at the Society for Immunotherapy of Cancer (“SITC”) 2025 Annual Meeting (Nov. 7-8, 2025, in National Harbor, MD).

Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development and Chief Medical Officer, commented, “We are highly encouraged by the strength and breadth of the T cell immunogenicity data emerging from the ongoing Phase 2 AMPLIFY-7P trial. Importantly, the robust mKRAS-specific responses were observed in patients with a highly diverse HLA background, underscoring the potential of ELI-002 7P to benefit a broad population of patients with KRAS-mutant pancreatic cancer. These findings are consistent with our Phase 1 results, where T cell responses correlated strongly with clinical activity in minimal residual disease–positive patients, and they further reinforce our confidence as we look ahead to the event-driven final disease-free survival analysis.”

Pete DeMuth, Ph.D., Elicio’s Chief Scientific Officer, added, “The preclinical data demonstrate that use of ELI-004 as an intra-tumoral immunotherapy induced complete eradication of advanced solid tumors in >90% of cases, followed by long-term protection against recurrence. These findings build on previous experience with ELI-004 as a subcutaneous adjuvant, to demonstrate preclinical efficacy when administered directly to solid tumors (intratumorally), where local immune activation alongside tumor-antigen release may synergize to induce protective anti-tumor immunity.”

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

Among 90 evaluable patients treated with ELI-002 7P in the ongoing Phase 2 AMPLIFY-7P trial, 99% achieved robust mKRAS-specific T cell responses, with a mean145-fold increase over baseline. Consistent and broad immunogenicity was observed, with 85% of patients showing combined CD4 and CD8 T cell activation—previously correlated with clinical activity—and 86% of mKRAS target antigens (540/630) eliciting immune responses. Notably, 67% of patients responded to all seven mKRAS epitopes, including >80% response rate to each individual KRAS mutation, and 88% generated responses to their own tumor-specific mutation, highlighting the personalized and durable immune activation possible with ELI-002 7P.

High-resolution human leukocyte antigen (“HLA”) typing and T cell immunogenicity was conducted on 89 patients treated with ELI-002 7P in the ongoing AMPLIFY-7P trial, revealing a highly diverse HLA repertoire with 1,132 unique HLAs across the primary class I and class II variants. In a two-variable analysis evaluating T cell fold change versus individual HLA alleles (restricting to alleles carried by ≥5 patients for statistical robustness), no meaningful associations were observed between specific HLA types and the magnitude of mKRAS-specific T cell responses. These findings suggest that ELI-002 7P can induce robust T cell immunity across a diverse HLA background, thereby supporting its potential applicability across a broad and genetically varied patient population.

The Company remains blinded to the Phase 2 trial clinical efficacy outcomes and to the potential correlation between observed T cell responses and antitumor responses in patients.

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

Therapeutic treatment of established solid tumors in mice with intratumoral ELI-004 induced complete eradication of tumors in >90% of cases; complete responders were protected from subsequent tumor recurrence 3-5 months following initial therapy suggesting robust development of immunological memory. Tumor response and full eradication were dependent upon the presence of CD8 T cells and effective trafficking of lymphocytes from lymph nodes, respectively, indicating a role of ELI-004 for initiation and support of local anti-tumor immune responses alongside induction of systemic immune responses in secondary lymphoid organs. Safe and effective therapeutic treatment, preclinically, with single or multi-dose intratumoral ELI-004 suggests this approach could present a promising off-the-shelf strategy for immunotherapy of solid tumors.

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.

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 immunization 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.

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 timing of the expected event-driven final disease-free survival analysis of the Phase 2 AMPLIFY-7P clinical trial; the potential of Elicio’s product candidates and platform, including the correlation of T-cell immune responses with ELI-002 2P and ELI-002 7P with clinical activity in minimal residual disease-positive patients; the possibility of personalized and durable immune activation from ELI-002 7P; the potential applicability of ELI-002 7P across a broad and genetically varied patient population; the potential of ELI-004 as a promising off-the-shelf strategy for immunotherapy of solid tumors; 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 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. 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, including the event-driven final disease-free survival analysis from the Phase 2 AMPLIFY-7P trial; 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 did Elicio (ELTX) report about ELI-002 7P immunogenicity on Nov 7, 2025?

ELTX reported 99% mKRAS-specific T cell responses in 90 evaluable patients with a mean 145-fold increase versus baseline.

How many AMPLIFY-7P patients generated cytotoxic mKRAS-specific T cells (ELTX)?

86.8% (66 of 76) of patients induced cytotoxic mKRAS-specific T cell responses.

Did ELI-002 7P responses vary by patient HLA (ELTX Nov 7, 2025)?

HLA typing across 89 patients found 1,132 unique alleles and no meaningful association between specific HLA types and response magnitude.

What preclinical results did Elicio present for ELI-004 at SITC 2025?

Intratumoral ELI-004 induced complete tumor eradication in >90% of mice and provided long-term protection against recurrence.

How common was combined CD4/CD8 activation with ELI-002 7P in AMPLIFY-7P?

85% of patients showed combined CD4 and CD8 T cell activation.

Does the Nov 7, 2025 update include Phase 2 clinical efficacy or survival data for ELTX?

No; the company remains blinded to Phase 2 clinical efficacy and disease-free survival correlations.