Napa9-SPG

LOS ANGELES, March 06, 2024 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today made the oral presentation “HepB-CpG Vaccine is Superior to HepB-alum in People with HIV and Prior Vaccine Non-Response (A5379)” at the Conference on Retroviruses and Opportunistic Infections (CROI 2024) in Denver, Colorado. These data demonstrated that the HepB-CpG vaccine achieved up to 99 percent protection among people living with HIV who had previously not responded to conventional hepatitis B vaccines, a noteworthy increase compared to the protection achieved by conventional vaccines. People living with HIV, especially those with lower CD4 counts, often do not develop protective antibodies after receiving conventional hepatitis B vaccines. The HepB-CpG (HEPLISAV-B®) vaccine includes a TLR-9 agonist adjuvant (CpG 1018® adjuvant) and is known to achieve high protection against hepatitis B among people living with HIV, but until now there have been limited data about its protection among people living with HIV who have not responded to conventional hepatitis B vaccines. “Hepatitis B remains a significant issue for people living with HIV, as having both viruses increases the likelihood of liver complications,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California Los Angeles. “Today’s presentation demonstrated extremely high rates of protection among those receiving the HepB-CpG vaccine and are likely to change clinical practice.” A5379 is an ongoing, open-label study that compares protection of the HepB-CpG vaccine to the conventional hepatitis B vaccine among people living with HIV who had not responded to prior hepatitis B vaccination and are on antiretroviral therapy (ART). Of the 561 eligible participants enrolled at 41 sites in 10 countries, 64 percent were male, 42 percent were Black, 35 percent were White, 17 percent were Asian, 22 percent were Hispanic, and the median age was 46 years old. They were equally randomized to one of three groups, receiving either: Two doses of HepB-CpG intramuscularly at week 0 and week 4Three doses of HepB-CpG intramuscularly at week 0, week 4, and week 24Three doses of HepB-alum (conventional hepatitis B vaccine) intramuscularly at week 0, week 4, and week 24 Today’s analysis showed that 93 percent of participants receiving two doses of the HepB-CpG vaccine and 99 percent receiving three doses of the HepB-CpG vaccine achieved protection against hepatitis B, compared to 81 percent receiving three doses of the conventional hepatitis B vaccine. The most frequently reported adverse events were vaccination site pain, fatigue, headache, malaise, and myalgia. No unexpected safety issues were observed. “In all of our HIV clinics, we see large numbers of people living with HIV who have been vaccinated against hepatitis B but show no evidence of a vaccine response,” said Lead Author and Protocol Co-Chair Kristen Marks, M.D., Weill Cornell Medicine. “Today’s remarkable findings are game changing for those individuals and offer them a potential path toward protection against hepatitis B.” A5379 is led by Kenneth Sherman, M.D., Ph.D., University of Cincinnati and Massachusetts General Hospital (Protocol Chair) and Dr. Marks. ACTG is led by Dr. Currier and Joseph J. Eron, M.D., University of North Carolina (ACTG Vice-Chair). It is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (which also funds ACTG) under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. HEPLISAV-B® was provided by Dynavax Technologies Corporation. About ACTGACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact:Rachel Reiss, ACTGRLReiss@mednet.ucla.edu

The presented data show ELI-005 elicits strong and long-lasting cellular and humoral immune responses that were maintained at significantly higher levels than comparator vaccines over 32 weeks in mice. ELI-005, containing the lymph node-targeted Amphiphile vaccine adjuvant AMP-CpG, induced potent, comprehensive and persistent innate immune responses in draining lymph nodes in mice. Animals treated with AMP-CpG showed a significantly higher percentage of CD8+ T cells with central memory phenotype, which resulted in more robust recall responses one week after antigen challenge in mice. ELI-005 rapidly induced potent cellular and antibody responses in non-human primates up to 5,000-fold over baseline which exhibited cross-reactive neutralization activity specific to Beta, Delta and Omicron SARS-CoV-2 variants of concern. BOSTON, July 06, 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 presentation of preclinical data on 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), demonstrating they 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 were presented in three posters at the 2022 Keystone Symposia on Viral Immunity: Basic Mechanisms and Therapeutic Applications virtually and in-person at the Keystone Resort in Keystone, CO from June 29-July 2, 2022. The electronic presentations are accessible here. While 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 the current pandemic and preparation for future pandemics driven by similar coronavirus pathogens. The robust immune responses generated by ELI-005 suggest that it may enhance broad protection against new variants of concern. “We are pleased to present updated data from ongoing preclinical work in mice and non-human primates with ELI-005, our lymph node-targeting AMP-vaccine against SARS-CoV-2. The truly exciting component of the data is that we are seeing an immune response that is very broad in its ability to recognize variants of concern that did not exist at the point when we were developing the approach. This potential to address many variants is critically important for any future coronavirus outbreaks,” said Peter DeMuth, Ph.D., Chief Scientific Officer at Elicio. “Overall, ELI-005 generated robust and durable responses from the two arms of adaptive immunity—cellular and humoral. These parallel responses are critical to providing optimal immune protection against pathogens like SARS-CoV-2 and support the differentiation of ELI-005 from existing COVID-19 vaccines.” Christopher Haqq, MD, Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer added, “These data sets validate our ability to deliver therapeutic payloads with the Amphiphile platform, driven by our Amphiphile modified TLR-9 agonist ELI-004, directly into the lymph nodes, the ‘schoolhouse of the immune system.’ This approach allows us to educate the T cells in the lymph nodes to recognize the antigen and develop persistent, broad immune specificity for a pathogen.” Poster Presentation Highlights Title: A lymph node targeted protein subunit vaccine induces robust cellular and humoral immunity to SARS-CoV-2 in non-human primates Highlights from the Presentation: ELI-005, containing the Amphiphile vaccine adjuvant AMP-CpG and WH-01 Spike receptor binding domain (RBD), induced polyfunctional antigen-specific CD8+ and CD4+ T cells in the peripheral blood of non-human primates.ELI-005 rapidly induced potent antibody responses in non-human primates up to 5,000-fold over baseline (reaching 104 binding antibody units/mL) which were cross-reactive to Beta, Delta and Omicron SARS-CoV-2 variants of concern.ELI-005 vaccination with AMP-CpG was safe and well tolerated with no observation of local reactogenicity, or abnormal changes in blood chemistry, hematocrit, body weight, body temperature or serum cytokine levels following each immunization. Title: A lymph node targeted protein subunit vaccine generates strong cellular and cross-reactive humoral immunity against SARS-CoV-2 with potent long-term recall responses Highlights from the Presentation: ELI-005 elicits strong and long-lasting cellular and humoral immune responses. Acute immune responses to ELI-005, one week after boost immunization, resulted in >60% of circulating and lung-resident CD8+ T cells, as well as nearly 10% of lung-resident CD4+ T cells to be reactive to RBD.Over 32 weeks, these responses were maintained at significantly higher levels than comparator vaccines, with 6% of circulating CD8+ T cells having maintained a cytokine+ status at 32 weeks.Animals treated with ELI-005 showed a significantly higher percentage of CD8+ T cells with central memory phenotype, which resulted in more robust recall responses one week after antigen challenge.Strong antibody responses, that were cross-reactive towards RBD variants, were generated and maintained throughout the course of the study. Title: A lymph node targeted CpG, TLR-9 agonist induces potent and persistent activation of lymphatic innate immune responses resulting in robust cellular and humoral immunity to SARS-CoV-2 Highlights from the Presentation: ELI-005, containing the lymph node-targeted Amphiphile vaccine adjuvant AMP-CpG, induced potent, comprehensive and persistent innate immune responses in draining lymph nodes.AMP-CpG induced increased numbers of all innate cell lineages in the lymph nodes, as well as increased numbers of innate cells expressing co-stimulatory molecules and producing key cytokines.In the lymph nodes, AMP-CpG upregulated numerous pro-inflammatory immune mediators associated with multiple axes of immune activation, including hematopoietic growth factors, cytokines and chemokines. About ELI-004 ELI-004 (AMP-CpG) is an Amphiphile modified TLR-9 agonist that is included in ELI-005. ELI-004 “hitchhikes” on endogenous albumin until it reaches antigen presenting cells in the draining lymph nodes to potently stimulate immune activation and support expansion of adaptive immune responses. ELI-004 has previously demonstrated at least 10-fold improved lymph node delivery, leading to substantially enhanced immune cell delivery and immune responses versus conventional CpG and other benchmark adjuvants. ELI-004 has demonstrated eradication and cures in multiple preclinical cancer models and activity against infectious diseases and, in this study, COVID-19. When the IND was approved for ELI-002 last year, IND approval for ELI-004 was automatically gained as well as it is 1 of 8 components in the asset. 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 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 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. Media Contact Gloria Gasaatura LifeSci Communications +1 646-970-4688 ggasaatura@lifescicomms.com