Elicio Therapeutics Stock Price, News & Analysis

Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company focused on developing novel immunotherapies for the treatment of cancer. According to company disclosures, Elicio is advancing a pipeline of investigational therapies for high-prevalence cancers, with a particular emphasis on tumors driven by mutations in the KRAS gene. The company’s work centers on off-the-shelf immunotherapies designed for patients with limited treatment options and a high risk of relapse.

Elicio is classified in the pharmaceutical preparation manufacturing industry within the broader manufacturing sector. As a clinical-stage company, its programs are in human trials and have not received marketing approval. Elicio’s strategy, as described in its public communications, is to build on clinical experience in personalized cancer immunotherapy to create off-the-shelf approaches that may be manufactured at scale and made rapidly available to patients.

Amphiphile (AMP) Platform and Lymph Node Targeting

A core element of Elicio’s approach is its proprietary Amphiphile (AMP) platform. Company materials describe this platform as a method for delivering investigational immunotherapeutics directly to the lymph nodes, which Elicio refers to as the “brain center” of the immune system. By binding to albumin at the injection site and trafficking through lymphatic vessels, AMP-modified agents are designed to concentrate in lymph nodes, where critical immune cells reside.

Elicio states that this lymph node–targeted delivery is intended to enhance the education, activation and amplification of cancer-specific T cells compared with conventional immunotherapy or vaccination strategies that do not specifically engage lymph nodes. In preclinical models described by the company, AMP-based delivery has been associated with immune responses of increased magnitude, function and durability. Elicio believes this lymph node–targeted approach may support induction and persistence of adaptive immunity that is required to treat many diseases, including solid tumors.

Lead Program: ELI-002 for mKRAS-Driven Cancers

The company’s lead product candidate is ELI-002,> an investigational AMP-based cancer immunotherapy that targets cancers driven by mutations in the KRAS gene. KRAS mutations are described by Elicio as a prevalent driver of many human cancers and as driving approximately 25% of all solid tumors. ELI-002 is designed as an off-the-shelf therapy rather than a patient-specific product.

According to Elicio, ELI-002 consists of two AMP-based components: AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant. ELI-004 is characterized by the company as an immune-stimulatory CpG oligonucleotide that activates TLR-9 and promotes innate immune activation and production of inflammatory mediators that support T cell responses. In its subcutaneous formulation, ELI-004 is intended to travel with albumin from the injection site to lymph nodes, where it can act on immune cells. ELI-002 is administered as an off-the-shelf subcutaneous regimen.

Elicio has developed two formulations of ELI-002. ELI-002 2P (2-peptide formulation) was evaluated in the Phase 1 AMPLIFY-201 trial in patients with high relapse risk mKRAS-driven solid tumors following surgery and chemotherapy. ELI-002 7P (7-peptide formulation) is being studied in a Phase 1/2 trial, AMPLIFY-7P, in patients with mKRAS-driven pancreatic ductal adenocarcinoma (PDAC). The 7-peptide formulation is designed to provide immune response coverage against seven of the most common KRAS mutations, which Elicio notes are present in roughly a quarter of all solid tumors. This design is intended to increase the potential patient population that could be addressed by ELI-002.

Clinical Focus: High-Risk Pancreatic and Colorectal Cancers

Elicio’s public statements emphasize a focus on mKRAS-positive pancreatic and colorectal cancers, which the company describes as high-prevalence cancers with significant unmet need. ELI-002 is being studied in an ongoing randomized clinical trial in patients with mKRAS-positive pancreatic cancer who have completed standard therapy but remain at high risk of relapse. ELI-002 has also been studied in patients with mKRAS-positive colorectal cancer (CRC) in Phase 1 studies.

Updated AMPLIFY-201 Phase 1 data for PDAC and CRC, as reported by the company, showed median recurrence-free survival and overall survival values for the study population; these data are used by Elicio to support further development of ELI-002. The company has also reported that in its Phase 1 trials, mKRAS-specific T cell responses above a certain fold-increase over baseline correlated with clinical activity in minimal residual disease–positive patients, and that combined CD4 and CD8 T cell responses were associated with clinical outcomes.

Phase 2 AMPLIFY-7P Trial and Immunogenicity Findings

In its ongoing Phase 2 AMPLIFY-7P trial of ELI-002 7P in mKRAS PDAC, Elicio has disclosed extensive immunogenicity data. Company communications report that approximately 99% of evaluable patients treated with ELI-002 7P generated mKRAS-specific T cell responses, with large fold increases over baseline. Elicio has also noted that a high proportion of patients developed both CD4 and CD8 mKRAS-specific T cell responses and that many patients responded to all seven mKRAS epitopes included in the vaccine, as well as to their own tumor-specific mKRAS mutation.

Further analyses described by Elicio indicate that these responses were observed across a highly diverse set of human leukocyte antigen (HLA) types. In a subset of patients, the company reports that 1,132 unique HLA types were represented, and that no meaningful association was observed between specific HLA alleles and the magnitude of mKRAS-specific T cell responses. Elicio interprets these findings as supporting the potential applicability of ELI-002 7P across a broad and genetically varied patient population.

In addition, Elicio has reported antigen spreading (epitope spreading) in a subset of Phase 2 patients, where treatment with ELI-002 7P was associated with T cell responses to tumor neoantigens beyond mKRAS that were not present in the targeted immunotherapy. The company notes that this expansion of immune responses to additional tumor-specific antigens may contribute to broader and potentially more durable anti-tumor immunity.

Pipeline Beyond ELI-002: ELI-004, ELI-007 and ELI-008

Beyond its lead program, Elicio describes a pipeline of additional off-the-shelf therapeutic cancer immunotherapy candidates built on the AMP platform. These include:

• ELI-004: an AMP-modified CpG oligonucleotide adjuvant and investigational immunomodulator. In addition to its role within ELI-002, ELI-004 is being studied preclinically as an intratumoral therapy for solid tumors. Elicio has reported that intratumoral administration of ELI-004 in preclinical models controlled growth and eradicated established solid tumors in a high proportion of cases and was associated with long-term protection against recurrence, dependent on CD8 T cells and lymphocyte trafficking from lymph nodes.
• ELI-007: an off-the-shelf therapeutic cancer immunotherapy candidate targeting BRAF-driven cancers, as described in company materials.
• ELI-008: an off-the-shelf therapeutic cancer immunotherapy candidate targeting p53 hotspot mutations.

Elicio positions these programs as extensions of its AMP platform into additional oncogenic drivers and tumor types, while maintaining an off-the-shelf, lymph node–targeted immunotherapy approach.

Off-the-Shelf Immunotherapy Strategy

In its public descriptions, Elicio contrasts its approach with personalized immunotherapy or vaccine strategies. The company states that off-the-shelf immunotherapy approaches may offer potential benefits such as lower cost, rapid commercial-scale manufacturing and rapid availability of drug to patients. Elicio highlights potential relevance for neo-adjuvant settings and for prophylaxis in high-risk patients, where timely access to therapy is important.

By targeting common driver mutations such as KRAS, BRAF and p53 hotspot mutations, and by using shared peptide antigens, Elicio aims to develop therapies that can be used across groups of patients without the need to custom-manufacture products for each individual. This strategy is presented by the company as a way to combine some of the conceptual advantages of personalized immunotherapy (such as targeting tumor-specific antigens) with the logistical advantages of standardized, off-the-shelf products.

Industry Classification and Exchange Listing

Elicio Therapeutics is categorized under pharmaceutical preparation manufacturing within the manufacturing sector. The company’s common stock trades on The Nasdaq Capital Market under the ticker symbol ELTX, as confirmed in its SEC filings. Elicio has identified itself as an emerging growth company under applicable U.S. securities regulations.

Use of Clinical and Preclinical Data

The company regularly reports clinical and preclinical data through press releases and SEC filings. These communications include immunogenicity metrics, T cell response rates, antigen spreading observations, and preclinical tumor eradication data. Elicio often links these findings to its broader development plans, including randomized trials in high-risk PDAC, Phase 1 studies in CRC, and potential expansion to other mKRAS-positive cancers such as lung cancer, as well as combination regimens with chemotherapy and checkpoint inhibitors in investigator-initiated studies.

While the company has described correlations between T cell responses and clinical activity in earlier-phase studies, it also notes in its disclosures that it remains blinded to certain ongoing Phase 2 efficacy outcomes and that forward-looking statements are subject to risks and uncertainties.

Research Collaborations and Academic Origins

Elicio reports that its AMP platform was originally developed at the Massachusetts Institute of Technology. The company also references the potential for advancing its platform through internal development, in-licensing arrangements, and collaborations or partnerships. In addition, Elicio has highlighted an investigator-initiated neoadjuvant trial of ELI-002 7P in PDAC led by Memorial Sloan Kettering Cancer Center and funded by the Lustgarten Foundation, which will evaluate ELI-002 7P in combination with chemotherapy and an anti–PD-1 antibody in resectable and borderline resectable PDAC.

Summary

According to its public disclosures, Elicio Therapeutics is a clinical-stage biotechnology company listed on Nasdaq that is focused on AMP-based, lymph node–targeted, off-the-shelf cancer immunotherapies. Its lead program, ELI-002, targets mKRAS-driven tumors and is being evaluated in PDAC and CRC, with extensive immunogenicity data reported from Phase 1 and Phase 2 studies. Additional candidates ELI-004, ELI-007 and ELI-008 extend the AMP platform to other tumor drivers and immunomodulatory strategies. The company positions its off-the-shelf, lymph node–targeted approach as a way to enhance cancer-specific T cell responses in high-prevalence, high-risk cancers.