- ELI-005 administration safely promotes robust cellular and humoral immunity through potent and targeted engagement of the lymph nodes in mice and non-human primates
- Prime-boost administration of ELI-005 induced long-lived and highly potent RBD-specific effector cytokine-producing T cell responses in mouse and non-human primate peripheral blood with both showing cross-reactivity against variants of concern
- Administration of ELI-005 produced rapid seroconversion and subsequent boosting of serum IgG with specificity against numerous RBD variants. Cross-reactivity was observed against ancestral, Beta, Delta and Omicron RBDs in non-human primates
BOSTON, March 29, 2022 – 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 spike receptor-binding domain (RBD) protein of SARS-CoV-2, and Elicio’s lymph node-targeted CpG TLR-9 agonist, Amphiphile-CpG (AMP-CpG), induce potent cross-reactive antibody and T cell responses in mice and non-human primates. ELI-005 yielded robust and durable cross-reactive serum IgG responses specific to several SARS-CoV-2 variants of concern alongside potent and cross-reactive peripheral T cell responses. The data is being presented at the Vaccines Summit held in Boston, MA from March 28-31, 2022. The electronic presentation is accessible here.
Despite the success of currently authorized vaccines for the reduction of severe disease risk from COVID-19, rapidly emerging viral variants continue to drive substantial pandemic waves of infection, resulting in numerous global public health challenges. Resolution of these challenges will depend on future advances in prophylactic vaccine activity, including the advancement of candidates capable of generating more potent induction of cross-reactive T cells and durable cross-reactive antibody responses. 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 new variants of concern.
“We are excited to see such a robust and persistent response across a number of variants of concern in both mice and non-human primates after prime-boost administration of ELI-005. In this study, we see highly potent RBD-specific T cell responses in multiple tissues in mice that aren’t seen in conventional, soluble CpG comparators which are poorly accumulated into draining lymph nodes. Additionally, in non-human primates we observed, in concert with RBD-specific IgG responses, cross-reactive T cell responses in peripheral blood at levels significantly increased relative to baseline,” said Peter DeMuth, Ph.D., Chief Scientific Officer at Elicio Therapeutics. “This suggests that AMP-CpG can simultaneously induce balanced cellular and humoral immunity with significant potential for cross-reactive recognition of known variants of concern, which builds upon our previous ELI-005 preclinical data. These data further validate the capabilities of our lymph node-targeting AMP platform across indications.”
Title: A lymph node-targeted protein subunit vaccine induces potent and cross-reactive cellular and humoral immunity to COVID-19 in mice and non-human primates
Highlights from the Presentation:
- ELI-005 administration safely promotes robust cellular and humoral immunity through potent and targeted engagement of the lymph nodes in mice and non-human primates.
- Prime-boost administration of ELI-005 induced long-lived, highly potent RBD-specific T cell responses in mouse peripheral blood, lungs and spleen, with frequencies of effector cytokine-producing CD8+ T cells rising to >60% directly ex vivo. Durable serum antibody responses were observed with cross-reactivity against variants of concern.
- Administration of ELI-005 produced rapid seroconversion and subsequent boosting of serum IgG with specificity against numerous RBD variants. Cross-reactivity was observed against ancestral, Beta, Delta and Omicron RBDs in non-human primates.
- ELI-005 induced effector cytokine-producing CD4 and CD8 T cell responses in the peripheral blood of non-human primates following booster administration, with cross-reactivity detected against variants of concern.
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 is thought 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 the third 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.wpengine.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 interpretation that the strong T cell responses generated by ELI-005 could enhance broad protection against new variants of COVID-19 and the general ability and potential of our proprietary Amphiphile, or AMP, platform, to deliver investigational immunotherapeutics directly to the lymph nodes, including across indications. 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.