Elicio Therapeutics Announces Publication of Preclinical Data in Science Translational Medicine Demonstrating the AMP Platform Promotes Uptake of Intranasal Vaccine in the Mucosa Amplifying Immune Response

• AMP-protein-based vaccines administered intranasally to mice and nonhuman primates (NHPs) were transported across the epithelial lining to the nasal-associated lymphoid tissue (NALT) and persisted in the nasal mucosa eliciting immune responses at both local and distal mucosal sites
  
  
• Intranasal immunization with AMP-conjugated HIV Env gp120 or SARS-CoV-2 receptor binding domain (RBD) proteins elicited 100- to 1000-fold higher antigen-specific IgG and IgA titers in the serum, upper and lower respiratory mucosa, and distal genitourinary mucosae of mice, and about 10-fold higher antigen specific responses in serum and nasal mucosa of NHPs compared to unmodified protein
  
  
• Data support further development of AMP-protein-based intranasal vaccines for immunogens such as the SARS-CoV-2 receptor binding domain and the HIV envelop proteins, among others
  

BOSTON, Oct. 04, 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 the publication of preclinical data from the research laboratory of Dr. Darrell Irvine at the Massachusetts Institute of Technology (MIT), demonstrating Elicio’s Amphiphile (AMP) platform conjugated to protein antigens promotes uptake in the nasal mucosa and amplifies immune responses after intranasal immunization. Immunization through airway surfaces has proven challenging due to poor vaccine uptake across these linings. The data presented here represents a promising strategy to promote mucosal immunity against HIV, SARS-CoV-2, and other infectious diseases. The data was published in Science Translational Medicine and can be accessed here.

“Delivery of vaccine components across mucosal barriers has been a major challenge for mucosal vaccine development. This data demonstrates that AMP-modification can improve vaccine uptake across the nasal mucosa via interactions with albumin and the neonatal Fc receptor known as the “mucosal gateway.” This enables higher concentrations of antigen in nasal associated lymphoid tissue – a specialized structure which organizes the immune response adjacent to the nasal passages,” said Darrell J. Irvine, Ph.D. inventor of the AMP technology, a Howard Hughes Medical Institute investigator and professor at MIT. “The findings are encouraging for the translational potential of this approach to induce antibodies in a variety of mucosal sites after intranasal immunization.”

Peter DeMuth, Ph.D., Elicio’s Chief Scientific Officer, added, “This is a fantastic new application of the platform with a lot of promise for new infectious disease vaccines intended to generate immunity at mucosal surfaces. These mucosal responses are important for protection against pathogens that typically invade mucosal sites in the respiratory or genitourinary tract and could block infection completely or reduce the amount of pathogen in mucosal sites, decreasing the risk of spread to others. The study demonstrates a new mechanism for AMP vaccines whereby small proteins modified with AMP can be more effectively delivered to the nasal associated lymph tissues. AMP-vaccines delivered this way induced stronger, more durable mucosal and circulating antibody responses in mice and non-human primates.”

Dr. DeMuth added, “The addition of these novel AMP mucosal vaccine candidates to our portfolio could significantly enhance our capabilities of targeting and potentially treating a variety of mucosal pathogens.”

Many pathogens enter through and utilize mucosal surfaces to infect their host. Infection via this route requires a multisystemic response involving both systemic and mucosal immune systems to work in tandem to protect the host. In addition to the robust engagement of both immune-globulin G (IgG) and IgA antibody responses seen with this investigational vaccine, intranasal vaccination offers several distinct advantages over injectable vaccines by targeting one of the areas that encounter the viral exposure first – the nose. Intranasal vaccine administration is most notably, easier to administer and requires less specific administration training than intramuscular injections. This administration route can also offer broader availability and readily available manufacturing in situations requiring mass vaccination and the potential for a higher compliance rate prompting a wave of vaccine manufacturers to target airways rather than muscles.    

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 or expectations for our lymph node-targeted approach to treating cancer and infectious diseases, our interpretation that this new application of the platform intranasally shows a promise for new infectious disease vaccines intended to generate immunity at mucosal surfaces, our belief that the mucosal responses could protect against pathogens that typically invade the mucosal sites in the respiratory and genitourinary tract and could completely block infection or reduce the amount of pathogen at mucosal sites and decrease the risk of spread to others, our belief that adding these AMP mucosal vaccine candidates to our portfolio could significantly enhance our capabilities of targeting and potentially treating a variety of mucosal pathogens, and our expectation that this administration route could offer broader availability and readily available manufacturing in situations requiring mass vaccination and the potential for a higher compliance rate prompting a wave of vaccine manufacturers to target airways rather than muscles.

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; the results do not continue to support the ability of intranasal vaccination to be effective; 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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