Elicio Therapeutics Announces Initiation of Its Phase 1/2 Dose-Escalation Study of ELI-002 (AMPLIFY-201) in KRAS-Driven Cancers

• Study will evaluate the safety and preliminary efficacy of ELI-002, an investigational lymph node-targeted therapeutic vaccine in patients with KRAS-driven tumors, and minimal residual disease following surgical resection
• Study will assess circulating tumor DNA (ctDNA) to obtain a preliminary indication of anti-tumor activity
• Study expected to enroll approximately 150 patients

CAMBRIDGE, Mass., June 29, 2021 (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 the initiation of AMPLIFY-201, a Phase 1/2 dose-escalation study evaluating the safety and preliminary efficacy of ELI-002, the Company’s therapeutic vaccine that is being investigated as a potential treatment for patients with KRAS-driven tumors who have minimal residual disease following surgical tumor resection. The trial will enroll patients with RAS-mutated pancreatic ductal adenocarcinoma (PDAC), colorectal cancer and other solid tumors with KRAS and NRAS mutations. ELI-002 is an investigational, subcutaneous, Amphiphile (AMP) KRAS therapeutic vaccine that targets the lymph node by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. It contains AMP mKRAS peptides and a proprietary AMP CpG adjuvant.

“RAS mutations, particularly KRAS mutations, are found in approximately 25% of tumors and have been considered difficult to target due to the number of mutations that can cause disease. In this study, our lymph node-targeted therapeutic vaccine ELI-002 is designed to target all seven common KRAS mutations, including G12C,” said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. “We believe that the ability of our proprietary AMP platform to deliver ELI-002 directly to the lymph nodes, the control center of the immune system, may stimulate an enhanced immune response.”

About AMPLIFY-201

AMPLIFY-201 is a Phase 1/2 clinical trial of ELI-002 in patients with solid tumors, including colorectal cancer, or CRC, or pancreatic ductal adenocarcinoma, or PDAC. The AMPLIFY-201 trial is being conducted at multiple sites, including U.S. cancer treatment institutions such as MD Anderson, Memorial Sloan Kettering, Sarah Cannon Research Institute, Massachusetts General Hospital, City of Hope, Washington University St. Louis, and Henry Ford Health System. Following an initial dose escalation phase, we intend to evaluate the potential of ELI-002 as a treatment for a number of KRAS-mutated cancers. AMPLIFY-201 is strategically constructed to target patients with minimal residual disease, or MRD, a stage where tumor burden and immunosuppressive effects within the tumor are lower. The Phase 1/2 trial employs an investigational in vitro diagnostic device, or IVD, that is intended to detect circulating tumor DNA, or ctDNA, and identify patients who show signs of minimal residual disease in their blood before relapse is detected in traditional radiographic scans.

Endpoints including safety, determination of maximum tolerated dose, ctDNA change from baseline, relapse free survival and immunological responses including lymph node enlargement, cytokine activity and immune response will be assessed. We anticipate initial safety, dose escalation, and correlative biomarker data from the Phase 1 portion of the trial to be available by the first half of 2022. Please refer to clinicaltrials.gov [NCT04853017] for additional clinical trial information.

The purpose of the Phase 1/2 multi-center, dose-escalation study is to evaluate the safety and preliminary efficacy of ELI-002 in patients with KRAS-driven cancers with minimal residual disease following surgery to remove the tumor. Patients will receive escalating doses of ELI-002 to determine safety and tolerability and to assess preliminary antitumor activity. The primary endpoints are, to define the maximum tolerable dose (MTD), recommended Phase 2 dose (RP2D), and incidence of adverse events (AE) for Phase 1 and relapse-free survival (RFS) for Phase 2. The secondary endpoints are, ctDNA clearance rate for Phase 1, and incidence of AEs, 1-year RFS, overall survival (OS) and the objective response rate (ORR) for Phase 2, among other endpoints. The trial is expected to enroll approximately 150 patients. Please refer to clinicaltrials.gov [NCT04853017] for additional clinical trial information.

About ELI-002

ELI-002 is a structurally novel investigational AMP therapeutic vaccine targeting KRAS-driven cancers. KRAS mutations are among the most prevalent human cancers. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified immune-stimulatory oligonucleotide adjuvant. The AMP mKRAS peptides and AMP CpG are targeted to the lymph node where they potentially enhance action on key immune cells.

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. Elicio began recruiting 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 the second quarter of 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 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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