Elicio Therapeutics Presents Preclinical Data on the

• Data shows that AMP-vaccination significantly enhanced TCR-T cell anti-tumor response while also inducing epitope spread among the endogenous T cell population, leading to durable cures of solid tumors in an established, syngeneic tumor model
• AMP-vaccination delivers cognate peptides and adjuvant to lymph nodes which induces dendritic cell activation and provides in vivo activation of tumor-specific TCR-T cells to amplify anti-tumor potency of adoptively transferred cells
• AMP-vaccination functionally expands tumor-specific TCR-T cells in vivo up to 46-fold
• These studies provide direct rationale and evidence for the combination of AMP-vaccination with TCR-T cell therapies to augment clinical responses

BOSTON, April 29, 2022 (GLOBE NEWSWIRE) — Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, today announced that it is presenting preclinical data demonstrating robust and durable anti-tumor responses by combining its Amphiphile (AMP) platform vaccine, carrying cognate peptide and adjuvant cargos, with T cell receptor T cell therapies (TCR-Ts). AMP cognate peptides traffic to the lymph nodes and are presented by activated antigen-presenting cells to improve TCR-T cell persistence and anti-tumor function. The data is being presented at the 2022 Keystone Symposia on Emerging Cellular Therapies virtually and in-person in Keystone, CO from April 27-May 1, 2022. The electronic presentation is accessible here.

“The efficacy of TCR-Ts in solid tumors has been promising but limited by challenges related to suboptimal T cell expansion, persistence and function as well as poor tumor infiltration and antigen escape. These data are particularly exciting because we have shown that TCR-Ts in combination with our AMP-vaccination platform can address each of these issues,” said Peter DeMuth, Ph.D., Chief Scientific Officer at Elicio Therapeutics. “By targeting AMP-peptide vaccination directly to the lymph nodes, we can promote antigen presentation alongside numerous complementary mechanisms critical for potent TCR-T cell enhancement and broad immune activation. We’ve seen that this potent activation in the lymph nodes results in TCR-T cell persistence and robust anti-tumor function.”

Robert Connelly, Elicio’s Chief Executive Officer, added, “The ability to enhance TCR-T clinical responses in solid tumors using the AMP platform supports our existing data across other immunotherapy platforms and indications, reinforcing the untapped potential of our lymph node-targeting strategy.”

TCR-T therapies are similar to CAR-T therapies but differ in the types of receptors they use to recognize antigens. TCR-Ts utilize the intrinsic antigen recognition mechanisms of the T cell and can even recognize intracellular antigens which makes them a powerful tool to target solid tumors. While this unique mechanism has shown clinical anti-tumor efficacy, TCR-T cells still face challenges that Elicio hopes to address by boosting TCR-T cell therapy in the lymph nodes, the “brain center” of the immune system, with its AMP platform.

Presentation Details

Highlights from the Presentation:

• AMP vaccination delivers cognate peptides and adjuvant to lymph nodes which induces dendritic cell activation and provides in vivo activation of tumor-specific TCR-T cells to amplify, both in quantity and function, the anti-tumor potency of adoptively transferred cells.
• AMP vaccination significantly enhanced TCR-T cell anti-tumor response while also inducing epitope spread among endogenous T cell population, leading to durable cures of solid tumors in an established, syngeneic tumor model.
• Vaccination with AMP-mKRAS peptides in mice expressing human leukocyte antigen A*11:01 (HLA A*11:01) significantly enhanced the activation, persistence and specific target lysis of murine mKRAS-specific TCR-T cells.
• AMP-peptide pulsed autologous human dendritic cells enhanced the function of several clinically relevant tumor-targeted human TCR-modified T cells in vitro including those targeting mKRAS, HPV16 E7 and NY-ESO-1.
• These studies provide direct rationale and evidence for the combination of AMP vaccination with TCR-T cell therapies to augment clinical responses.

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.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases and other disease indications 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 therapeutic 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 and other diseases. By combining expertise in immunology and immunotherapy, Elicio is engineering investigational Amphiphile immunotherapies that are 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 and infectious diseases.

Elicio began dosing subjects in AMPLIFY-201, its Phase 1/2 clinical trial in solid tumor subjects for its lead Amphiphile vaccine, ELI-002, targeting KRAS-driven cancers in October 2021. The Amphiphile 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. For more information, please visit https://elicio.com/.

Cautionary Note on Forward-Looking Statements

This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties, assumptions and other important factors that could cause our actual results, performance or achievements to differ materially from historical results or any future results, performance or achievements expressed, suggested or implied by such forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding or expectations for our lymph node targeted approach to treating cancer and infectious diseases, our expectation that the AMP platform can boost TCR-T cell therapy in the lymph nodes, the ability of our proprietary AMP platform to deliver ELI-002 directly to the lymph nodes and our belief that it may stimulate an enhanced immune response and the general ability and potential of our proprietary Amphiphile, or AMP, platform, to deliver investigational immunotherapeutics directly to the lymph nodes. Applicable risks and uncertainties that could cause our actual results, performance or achievements to differ materially from historical results or any future results, performance or achievements expressed, suggested or implied by our forward-looking statements include, among others: the potential that we experience slower than expected enrollment in our clinical trials, we identify serious side effects or other safety issues, we do not have clinical supply of our product candidate that is adequate in amount and quality and supplied in a timely fashion, and the inherent risks of clinical development; the results of our clinical trials do not continue to support our approach and expectation of lymph node targeting for the treatment enhance of cancer and infectious diseases or that the results do not continue to support that the AMP platform enhances TCR-T clinical responses in solid tumors; our limited operating history and historical losses; our need to raise capital to fund our research and development programs; the early stage nature of the development of our product candidates; our ability to obtain orphan drug designation from the FDA; competition from various competitors in the markets targeted by our product candidates, including from competitors with substantially greater resources than us; our general dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; the potential complexity of the manufacturing process for our product candidates; our ability to protect our intellectual property; our dependence on the patents we license from the Massachusetts Institute of Technology, or MIT; our compliance with healthcare laws and regulations; and risks relating to the impact on of COVID-19 or other infectious diseases on our business. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we do not undertake and specifically disclaim any obligation to update any forward-looking statements, except as required by law.

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