Data published in bioRxiv shows 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 (NHPs)
Prime-boost administration of ELI-005 induced potent Spike receptor binding domain (RBD)-specific effector cytokine-producing T cell responses in mouse and NHP peripheral blood showing cross-reactivity against variants of concern
Antibody neutralizing activity from vaccinated NHPs was specific for multiple viral variants of concern, including Omicron, at levels ~10-fold increased relative to levels in convalescent human patients
In mice, AMP-CpG induced increased numbers of innate immune cells expressing co-stimulatory molecules and producing key cytokines, correlated with significant increases in lymph node inflammatory proteomic and transcriptomic signatures
BOSTON, September 7, 2022 – Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, today announced the publication of data from a preclinical study evaluating ELI-005, Elicio’s Amphiphile (AMP) adjuvant, AMP-CpG, admixed with the SARS-CoV-2 Spike receptor binding domain (RBD) immunogen, as a lymph node-targeted protein subunit vaccine. The results show ELI-005 administration safely promotes robust cellular and humoral immunity through potent, targeted engagement of the lymph nodes in both mice and non-human primates (NHPs). Additionally, these data demonstrate the promise of lymph node adjuvant-targeting to coordinate innate immunity and the generation of robust adaptive responses that are critical for vaccine efficacy. These results were published in the preprint server, bioRxiv, and can be accessed here.
“We are thrilled to see robust and persistent responses across several SARS-CoV-2 variants of concern with our lymph node-targeted protein subunit vaccine, ELI-005, in preclinical models predictive of human immunity,” said Robert Connelly, Chief Executive Officer at Elicio. “These data build on what we are seeing in all of our ongoing preclinical and clinical programs in oncology and infectious diseases, demonstrating the ability of our AMP platform to efficiently deliver immunotherapeutics directly to the lymph node eliciting potent immune responses.”
Although currently authorized vaccines have shown success in 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. Future advances in prophylactic vaccine activity will play a critical role in the resolution of these challenges as will the advancement of candidates capable of generating more potent induction of cross-reactive T cells and durable cross-reactive antibody responses. In the absence of sterilizing immunity, robust memory B and cross-reactive T cell responses that are capable of rapid re-activation could provide effective long-term protection against the worst outcomes of disease. The spike RBD domain plays an important role in promoting neutralizing antibody responses to SARS-CoV-2 in the immune system. The robust immune responses generated by ELI-005 suggest that it may enhance broad protection against new variants of concern.
Peter DeMuth, Ph.D., Chief Scientific Officer, added, “We’ve seen that AMP-directed biodistribution of vaccine components to the draining lymph node can significantly improve delivery to important immune cells. This improved delivery can engage mechanisms of the immune response that enhance the magnitude and quality of the response while mitigating exposure to immunologically irrelevant or tolerizing sites. We feel that this is a huge step forward in potential prophylactic vaccine development because of the resulting strong memory B cell and durable cross-reactive T cell responses we have seen. Vaccines, like ELI-005, capable of promoting responses with these immunological features may provide improved patient outcomes while also preventing the emergence of future coronavirus pathogens resulting from increasing exposure to these pathogens in our everyday lives.”
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.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 or expectations for our lymph node-targeted approach to treating cancer and infectious diseases, 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, our expectation that advances in prophylactic vaccine activity and the advancement of candidates capable of generating more potent induction of cross-reactive T cells and durable cross-reactive antibody responses will play a critical role in the resolution of the current pandemic and preparation for future pandemics driven by similar coronavirus pathogens.
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; the results of our clinical trials do not continue to support our approach and expectation of lymph node targeting for the enhanced treatment of cancer and infectious diseases or that the results do not continue to support that the AMP platform enhances TCR-T clinical responses in solid tumors; 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.