ELTX Elicio Therapeutics Inc

Elicio Therapeutics (NASDAQ:ELTX), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced the publication of preclinical data demonstrating its lymph node-targeting Amphiphile (AMP) adjuvant, AMP-CpG, combined with cell surface-associated viral protein EBV gp350 and EBVpoly protein, elicited a potent and durable immune response to Epstein-Barr virus (EBV) in Human Leukocyte Antigen expressing mice. The data was published in Nature Communications and can be accessed here.

EBV is the herpesvirus responsible for common mononucleosis infections (“mono”) and has also been implicated in multiple lymphoid and epithelial cancers, as well as development of the auto-immune disease multiple sclerosis. Prior EBV immunization efforts have not been able to generate robust immune responses sufficient to protect against EBV-infection or associated disease. Subunit vaccines are an attractive strategy but have been limited because of poor accumulation into lymph nodes where protective immunity is generated. By contrast, AMP-CpG directed the trafficking of the vaccine adjuvant into the lymph node to increase the potency of subunit vaccines for inducing T-cells and neutralizing antibodies.

“We are excited about this data as it demonstrates our AMP platform generated robust and persistent virus-specific cellular and humoral immunity in an infectious disease model. These data again show that the addition of AMP-CpG enhanced the delivery of a vaccine to the lymph node resulting in a significantly elevated T-cell response.   This will be beneficial in potentially providing protection against EBV-infection and the development of EBV-associated diseases.” said Peter DeMuth, Ph.D., Elicio’s Chief Scientific Officer. “We also demonstrated the elimination of EBV+ tumor cells by EBV-specific immune responses in mice and observed subcutaneous tumor growth delay or complete prevention in these animals. These data not only demonstrate an exciting opportunity for a potential EBV vaccine but also validate the utility of the AMP platform to improve lymph node immune activation resulting in potent immune responses against historically challenging pathogens.”

Dr. Rajiv Khanna, Professor, Senior Scientist and Coordinator of QIMR Berghofer’s Centre for Immunotherapy and Vaccine Development who leads the research on which the EBV vaccine is based, added, “There are currently no approved vaccines for EBV and its viral attributes driving B cell latency and its immune modulation properties which enable it to evade antibody targeting have made effective vaccine design for EBV difficult. We are encouraged by the results from this study that have shown the potential to overcome these limitations. The evidence supports co-administration of AMP-CpG with EBV protein subunit immunogens of relatively large molecular size as a viable option for concerted accumulation of antigen and adjuvant in draining lymph nodes to promote potent immunity.”

Robert Connelly, Chief Executive Officer of Elicio, added, “We are excited about the versatility of the AMP platform and the potential of lymph node targeting to improve immunity across indications in oncology and infectious disease. The first-in-human safety data presented in June at ASCO1, the data in this paper demonstrating utility in an infectious disease model and the Cell paper2 recently published by our scientific founder in cellular therapy support broad applicability of the AMP platform. Our near-term focus, however, remains progressing ELI-002, our cancer vaccine candidate for mutant KRAS-driven solid tumors, through the ongoing phase 1 trials and to a randomized trial in pancreatic cancer in 2024.”

About the Amphiphile Platform

Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. We believe 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, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based upon preclinical studies.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, 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 Amphiphile platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph node-specific engagement driving immune responses of increased magnitude, function and durability.

About Elicio Therapeutics

Elicio Therapeutics is a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer. By combining expertise in immunology and immunotherapy, Elicio is engineering investigational Amphiphile (AMP) immunotherapies intended to precisely target and fully engage the lymph nodes, the site in our bodies where the immune response is orchestrated. Elicio is engineering lymph node-targeted AMPlifiers, immunomodulators, adjuvants and vaccines for an array of aggressive cancers.

Elicio began dosing subjects in AMPLIFY-201, its Phase 1 clinical trial in solid tumor subjects for its lead AMP vaccine, ELI-002 2P, targeting mKRAS-driven cancers, in October 2021 and began dosing subjects with the new formulation, ELI-002 7P, in April 2023. The AMP platform emerged from the laboratories of Darrell Irvine, Howard Hughes Investigator and Professor of Biomedical Engineering in the Koch Institute of Integrative Cancer Research at MIT.

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 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; Elicio’s ability to successfully collaborate with existing collaborators or enter into new collaborations, and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of Elicio’s product candidates; Elicio’s commercialization, marketing and manufacturing capabilities and strategy; Elicio’s ability to identify additional products or product candidates with significant commercial potential; developments and projections relating to Elicio’s competitors and our industry; the impact of government laws and regulations; Elicio’s ability to protect its intellectual property position; 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 us to predict all such factors, nor can we 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 in the proxy statement/prospectus/information that is included in the registration statement on Form S-4 (File No. 333-269741) that was filed with the SEC and Elicio’s periodic 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.

Media Contact

Gloria Gasaatura

LifeSci Communications

ggasaatura@lifescicomms.com

646-970-4688

Investor Relations Contact

Heather DiVecchia

Elicio Therapeutics

IR@elicio.com

857-209-0153

1 Elicio Therapeutics. (2023, June 3). Elicio Therapeutics Announces Positive Interim Data from the Phase 1 Study of an Investigational Therapeutic Cancer Immunotherapy, ELI-002, in Patients with High Relapse Risk Pancreatic and Colorectal Cancer at the ASCO Annual Meeting [Press release]. https://ir.elicio.com/news-releases/news-release-details/elicio-therapeutics-announces-positive-interim-data-phase-1

2 Ma, L., Hostetler, A., Morgan, D. M., Maiorino, L., Sulkaj, I., Whittaker, C. A., Neeser, A., Susin Pires, I., Yousefpour, P., Gregory, J., Qureshi, K., Dye, J., Abraham, W., Suh, H., Li, N., Love, J. C. & Irvine, D. J. (2023). Vaccine-boosted CAR T crosstalk with host immunity to reject tumors with antigen heterogeneity. Cell, 186(15), 3148-3165. https://doi.org/10.1016/j.cell.2023.06.002