• ELI-005, containing the Amphiphile vaccine adjuvant AMP-CpG, induced >25-fold higher antigen-specific T cells in the peripheral blood and exhibited potent killing of antigen-positive targets in vivo that were maintained for >5 months after vaccination
  • Vaccine responses were highly cross-reactive to SARS-CoV-2 variants of concern
  • Antibody responses favored TH1 isotypes with titers 265-fold higher than natural convalescent patient COVID-19 responses
  • Results suggest delivery of AMP-CpG to lymph nodes could be applied to rapid development of prophylactic or therapeutic vaccine candidates targeting a variety of disease-specific antigens

CAMBRIDGE MA, USA I September 22, 2021 I Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, today announced positive preclinical data demonstrating that ELI-005, a protein subunit vaccine containing the lymph node-targeted Amphiphile-CpG adjuvant (AMP-CpG), induces potent cellular and humoral immunity to SARS-CoV-2 at the 2021 Vaccines Summit, being held virtually on September 20-22, 2021.

“We are encouraged by these positive results for ELI-005 demonstrating that delivery of AMP-CpG adjuvant to the lymph nodes induces both cellular and humoral responses to SARS-CoV-2 antigens. This dual response is critical in developing broad protective immunity in patients,” said Peter DeMuth, Ph.D., vice president of research at Elicio Therapeutics. “The cross-reactivity to variants of concern and induction of potent potentially cross-reactive T cells are crucial benefits as the virus continues to evolve. Although we are still in the early stages of studying this adjuvant, this data shows AMP-CpG has the potential to enhance a broad spectrum of vaccines beyond SARS-CoV-2.”

Elicio assessed the ability of ELI-005, containing AMP-CpG, to promote immunity directed against an admixed SARS-CoV-2 Spike receptor binding domain (RBD) protein in mice and non-human primates. Comparator vaccination with alum and unmodified CpG were included to assess immune response induction of a lymph node targeted adjuvant relative to either a depot forming or systemically distributed adjuvant. The results suggest that efficient delivery of AMP-CpG to the lymph nodes enables cellular and humoral immunity and can be applied for rapid development of prophylactic or therapeutic vaccine candidates targeting a variety of disease specific antigens.

Several circulating SARS-CoV-2 strains have emerged underscoring the need for a vaccine that will protect against the variants of concern. The Spike RBD sequence is an important target for the immune response because it is the target for neutralizing antibody responses to SARS-CoV-2. These Spike antigens also contain T cell epitopes which generate cell mediated immunity. The strong T cell responses generated by ELI-005 suggest that it may enhance broad protection against these variants since most amino acid regions recognized by T cells have been conserved in variants of concern including the Beta (B.1.351) and Alpha (B.1.1.7) strains.

Christopher Haqq, M.D., Ph.D., Elicio’s executive vice president, Head of Research and Development, and chief medical officer, added, “This data on ELI-005 shows the potential of our AMP platform to address various diseases by delivering immune therapies and vaccines directly to the lymph nodes, the home of the immune system, activating a potent, functional and durable immune response. We hope to bring much-needed lymph node targeted therapies to patients soon.”

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.

SOURCE: Elicio Therapeutics