Elicio Therapeutics Receives $2.8 Million Grant from the Gastro-Intestinal Research Foundation (GIRF) to Fund Research for Two Therapeutic Cancer Vaccines

• Funds will advance research into ELI-007 as a mutant BRAF-peptide vaccine and ELI-008 as a p53 hotspot mutation-peptide vaccine, with the aim of developing multivalent cancer vaccines targeting several mutations

BOSTON, Sept. 20, 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 has been awarded a $2.8 million grant from the Gastro-Intestinal Research Foundation (GIRF) in Chicago to fund research for two therapeutic cancer vaccines. Both vaccines have been designed with Elicio’s proprietary lymph node-targeting Amphiphile (AMP) platform that “educates” T cells on how to target particular antigens, such as mutated proteins in cancer. ELI-007 is being developed to target the BRAF gene mutation, and ELI-008 is being developed to target hotspot mutations in p53 in solid tumors including colorectal cancer, melanoma and non-small cell lung cancer (NSCLC). BRAF V600E mutations are present in 40% of melanoma, 10% of colon cancer and 2% of lung cancer while mutations in p53 are found in approximately 60% of patients with solid tumors.

“We are excited to receive the grant from GIRF and look forward to broadening our pipeline by developing ELI-007 and ELI-008 to target these key cancer mutations. p53 hotspot mutants and mutant BRAF are examples of public cancer neoantigens shared across many patients and tumor types with limited therapeutic options for providing durable therapeutic benefit,” said Peter DeMuth, Ph.D., Chief Scientific Officer at Elicio. “By targeting vaccine components to the lymph nodes, the AMP strategy is ideally suited to enhance tumor-specific immunity with the potential to eradicate tumors and promote durable patient responses.”

Previous research has shown that T cells can respond to the driver mutation V600E in BRAF and that transfer of tumor-infiltrating lymphocytes that recognize mutated BRAF resulted in a durable complete response in a case study. In addition, small molecule inhibitors generate initial responses in BRAF V600E-mutated melanoma, but these are not sustained because of resistance due to alternative growth signaling pathways, and few initial responses occur in BRAF-mutated colon cancer. The protein expression of BRAF V600E is maintained at high levels in these tumors suggesting that they would be susceptible to T cells specific for the mutated BRAF.

Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer, added, “These mutations are recognized by some patients’ T cells at low levels, and when T cells recognizing tumor-associated antigens like p53 were present, progression-free survival in NSCLC was prolonged. The development of ELI-007 and ELI-008 represents the next level for our current pipeline of lymph node-targeted assets that includes ELI-002, a therapeutic cancer vaccine, which is currently in Cohort 3 of a Phase 1/2 trial in patients with mKRAS tumors. We have prioritized application of our AMP platform to promote immunity against validated cancer targets like BRAF and p53, so the support from GIRF, which is at the forefront of research in the gastrointestinal space including within oncology, is a great opportunity to work together to improve patient outcomes.”

Jackie Casey, J.D., Executive Director, Gastro-Intestinal Research Foundation, added, “Patients have been at the center of our work at GIRF from the very beginning, and this grant is reflective of our mission to transform lives through groundbreaking research. Elicio’s AMP platform has demonstrated the potential to amplify the number of T cells and expand their function with promising data. With directed funds from a generous donor, we are proud to support this innovative biotech company as it pushes boundaries in therapeutic cancer vaccine development.”

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 our expectation to broaden our pipeline by developing ELI-007 and ELI-008 to target BRAF V600E mutations and mutations in p53, our belief that the AMP strategy is ideally suited to enhance tumor-specific immunity with the potential to eradicate tumors and promote durable patient responses, our expectation that the support from GIRF presents a great opportunity to work together to improve patient outcomes, our belief that Elicio’s AMP platform has potential to amplify the number of T cells and expand their function and the expectation that we are pushing boundaries in therapeutic cancer vaccine development. 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: that our research does not yield our expected results, 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; 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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