Elicio Therapeutics Reports Robust T cell Responses Across Diverse HLA backgrounds in Ongoing Phase 2 AMPLIFY-7P Trial

Rhea-AI Summary

Elicio Therapeutics (Nasdaq: ELTX) reported preliminary Phase 2 AMPLIFY-7P results showing that ELI-002 7P induced mKRAS-specific T cell responses across diverse HLA backgrounds.

Among 89 patients, 1,132 unique HLA types were identified out of 1,398 total HLA types assessed, and 99% (88/89) of patients assessed for HLA background mounted mKRAS-specific T cell responses after treatment. The company said these findings suggest mKRAS antigens can be presented across many HLA alleles, implying potential applicability to a broad population of pancreatic ductal adenocarcinoma (PDAC) patients.

Results are described as preliminary and come from an ongoing Phase 2 study; additional data and follow-up were not provided.

Positive

• 99% response rate (88/89 patients) for mKRAS-specific T cells
• 1,132 unique HLA types represented among treated patients
• Findings suggest broad HLA coverage for mKRAS antigen presentation

Negative

• Data are preliminary from an ongoing Phase 2 trial
• Analysis is based on 89 patients, a limited sample size for broad generalization

• ELI-002 7P demonstrated robust mKRAS-specific T cell responses across a broad range of HLA types, highlighting its potential for use among a diverse patient population
• Patients treated with ELI-002 7P represented a diverse HLA repertoire including 1,132 unique types identified among 1,398 total HLA backgrounds in assessed patients
• 99% (88/89) of patients assessed for HLA background induced mKRAS-specific T cell responses after treatment with ELI-002 7P
• Induction of mKRAS-specific T cell responses suggest that ELI-002 7P may address a broad patient population with high unmet need for pancreatic ductal adenocarcinoma (“PDAC”)

BOSTON, Oct. 27, 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 preliminary analysis of patients in the ongoing Phase 2 AMPLIFY-7P trial indicated that specific Human Leukocyte Antigen (“HLA”) types (alleles) were not associated with a patient’s ability to elicit robust mKRAS-specific T-cell response following treatment with ELI-002 7P. 

Among 89 patients treated with ELI-002 7P, a total of 1,132 unique HLAs were represented across the primary class I and class II variants, highlighting substantial genetic diversity within the study population. These findings are consistent with a growing body of evidence indicating that mKRAS antigens can be presented across a broad range of HLA types. Elicio’s data is consistent with recent analysis published in Cell Reports Methods that found T cells specific to mKRAS G12D and/or G12V in 20/20 (100%) healthy donors evaluated across a diverse HLA background, suggesting that the majority of patients possess mKRAS-presenting HLAs and include mKRAS-specific T cell responses within their immune repertoire.

Robert Connelly, Chief Executive Officer of Elicio, commented, “We are extremely pleased to see that mKRAS-specific T cell responses are induced among patients with a diverse HLA background, suggesting that ELI-002 7P may be applicable to a broad range of PDAC patients potentially addressing a key unmet need and expanding the potential market opportunity. Our observations build on past data to show that the majority of patients express mKRAS-presenting HLAs, likely enabling T cell recognition in most patients. These encouraging findings highlight the potential for ELI-002 7P to benefit a broader spectrum of PDAC patients, which may extend the reach of immunotherapy to more individuals and address a critical unmet need.”

Diverse HLA Representation Present in ELI-002-7P Treated Patients in AMPLIFY-7P Phase 2

		Number of Unique HLA Types
HLA Class I	HLA-A	116
	HLA-B	158
	HLA-C	118
HLA-Class II	HLA-DR	292
	HLA-DP	180
	HLA-DQ	268
Total Unique HLA Types		1132
Total HLA Types		1398

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 suggestion that ELI-002 7P may have applicability in a broad range of PDAC patients due to the induction of mKRAS specific T cell responses among patients with a diverse HLA background; the potential transformational approach ELI-002 could represent in the treatment of mKRAS-driven tumors; the potential impact of ELI-002 in PDAC, including the potential to address a key unmet need and expand the potential market opportunity; the potential for future expansion of ELI-002 to other indications, including in combination regimens for PDAC and colorectal cancer; 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; 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 announce about ELI-002 7P in the AMPLIFY-7P Phase 2 trial (Oct 27, 2025)?

Elicio reported that ELI-002 7P induced mKRAS-specific T cell responses in 99% (88/89) of assessed patients across diverse HLA backgrounds.

How many unique HLA types were identified in Elicio's AMPLIFY-7P patients (ELTX)?

Patients represented 1,132 unique HLA types out of 1,398 total HLA types assessed in the study population.

Does the AMPLIFY-7P data indicate ELI-002 7P could work across diverse PDAC patients (ELTX)?

The company said the data suggest mKRAS antigens are presented across many HLA alleles, implying potential applicability to a broad PDAC population.

Is the AMPLIFY-7P result final and conclusive for ELTX investors?

No; the company described the findings as preliminary from an ongoing Phase 2 trial and did not provide final efficacy or long-term outcome data.

What sample size supports Elicio's HLA diversity claim in AMPLIFY-7P (ELTX)?

The claim is based on 89 patients treated with ELI-002 7P in the reported analysis.

How might the AMPLIFY-7P HLA findings affect ELTX's potential market for PDAC therapy?

Elicio suggested that broad HLA representation and high T cell induction could expand potential applicability of ELI-002 7P to more PDAC patients, though further data are needed.