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Elicio Therapeutics Presents Preclinical Data on AMP TCR-T Combination Therapy in Solid Tumors at the CAR-TCR Annual Summit 2021

Data showed AMP combination with TCR-T cell therapy promotes durable responses against aggressive solid tumors in a mouse model where TCR-T cells alone have no effect

AMP combination with TCR-T cell therapy induces marked T cell expansion, solid tumor infiltration, and optimal phenotype/function correlated to durable responses

Improved durable responses in mice were associated with coordinated upregulation of inflammatory genes in lymphatics and tumor microenvironment which correlated to antigen spreading and enhanced endogenous T cell responses against diverse tumor antigens

CAMBRIDGE MA., September 10 2021 – 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 presented preclinical data on its Amphiphile (AMP) platform in combination with TCR-T therapy in solid tumors at the 6th Annual CAR-TCR summit, that was held virtually from August 30 – September 2, 2021. The data was presented in a session co-chaired by industry leaders Adrian Bot, MD, PhD, Vice President of Translational Medicine at Kite, and member of Elicio’s Scientific Advisory Board, and Christopher Heery, MD, Chief Medical Officer of Arcellx Inc., as part of the “Understanding and Managing Toxicity to Enhance Patient Outcomes” workshop.

“The preclinical data showed that AMP-boosting transformed an ineffective TCR-T cell monotherapy regimen into a combination which induced long-term non-progression in a fraction animals. It also showed that the AMP combination therapy not only enhanced the expansion and functionality of transferred TCR-T cells but also induced a T-cell response to additional tumor antigens from the original therapy, called antigen spreading, to more broadly attack the tumor.” said Peter DeMuth, Ph.D., Elicio Vice President of Research. “We are encouraged by these results because they demonstrate the AMP platform’s ability to enhance multiple axes of immune activation, both systemically as well as in the tumor microenvironment, which may help overcome known challenges to T cell therapy for solid tumors in the clinic.”

Adrian Bot, MD, PhD, co-chair of that session, added, “Elicio’s AMP technology is showing promising results in terms of enhancing T cell therapy, through effectively restimulating in vivo the T cells, via deployment of professional antigen presenting cells and co-delivery of biological response modifiers.”

This effort expands on the previous work reported in Science from studies conducted at MIT and exclusively licensed to Elicio combining AMP and CAR-T.  As observed in the TCR-T combination setting, AMP-boosting of CAR-T cells can promote CAR-T expansion and solid tumor infiltration, contributing to durable responses and resistance to relapse due to loss of CAR-target loss in recurring tumors.  Elicio is currently applying this strategy in collaboration with Moffitt Cancer Center to improve CAR-T cell therapies for patients with hematological cancers.  This effort is focused on evaluating the combination of CD19 CAR-T AMPlifier, referred to as ELI-011, together with CD19-targeted CAR-T therapy, in mouse models of B cell lymphoma. Positive results in these preclinical assessments may support the advancement of the program into clinical trials.

Presentation will be available on the Elicio Therapeutics website following the Summit via link.

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.

Amphiphile platform is thought to deliver immunotherapeutics to target the lymph node 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. 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 our plans with respect to our Phase 1/2 Dose-Escalation Study of ELI-002 (AMPLIFY-201), the ability of ELI-002 to target all seven common KRAS mutations, including G12C, 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, the timing of the availability of initial safety, dose escalation, and correlative biomarker data from the Phase 1 portion of AMPLIFY-201, 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; 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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