If you continue to use this site we will assume that you are happy with it. Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of data readouts from ALT-801 clinical trials in the second half of 2021 and beyond, sufficient cash on hand to fund the Company into 2023, the prospects for regulatory approval, our ability to manufacture material for our clinical trials and commercial needs, and commercializing or selling any product or drug candidates, including ALT-801 and HepTcell, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Officers with the Supreme Court police discover a shocking crime--an anonymous person has smuggled a dead baby into the Supreme Court building. wbrown@altimmune.com, © 1985 - 2021 BioSpace.com. The Phase 1 AdCOVID clinical trial is evaluating the safety and immunogenicity of the intranasally administered vaccine candidate in approximately 80 healthy adult volunteers between the ages of 18 and 55. Brief Summary: This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age. We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID.”, “The top-line Phase 1 clinical data are disappointing given the encouraging preclinical data and our substantial efforts in advancing a differentiated, intranasal vaccine candidate in the fight against COVID-19,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. Detailed Description: This study is an extension to Study ALT-103-201 to evaluate immunogenicity of NasoVAX administered by intranasal spray at a single dose of 1×1011 vp at Day 366 (± 60 days). Our pipeline includes next generation peptide therapeutics for obesity, NASH (ALT-801), and chronic hepatitis B (HepTcell™); proprietary intranasal vaccines; and an immune modulating therapeutic for COVID-19 (T-COVID™). Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of data readouts from ALT-801 clinical trials in the second half of 2021 and beyond, sufficient cash on hand to fund the Company into 2023, the prospects for regulatory approval, our ability to manufacture material for our clinical trials and commercial needs, and commercializing or selling any product or drug candidates, including ALT-801 and HepTcell, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Altimmune Begins Multinational Phase 2 Clinical Trial of HepTcellTM, a Novel Immunotherapeutic for the Treatment of Chronic December 30, 2020, 8:00 AM EST SHARE THIS ARTICLE GAITHERSBURG, Md., June 29, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today provided an update on its AdCOVID investigational vaccine for the prevention of COVID-19. Condition or disease. Found inside – Page 137Brown W (2020) Altimmune announces IND clearance for a phase 2 trial of HepTcellTM immunotherapeutic for the treatment of chronic hepatitis B. In: Altimmune (ed) Globe newswire. Altimmune, Gaithersburg 86. Lim YS, Mutimer D, ... With this milestone, the data readout for the Day 28 immunogenicity endpoint remains on … Most of these limitations of the current vaccines are being addressed by research on novel approaches to vaccine development and delivery that are described in many of the chapters in this volume. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2020 filed with the SEC, which is available at www.sec.gov. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2020 filed with the SEC, which is available at www.sec.gov. The first 2 cohorts were designed to assess the safety of T-COVID treatment and were comprised of COVID-19 infected patients 49 years or younger with a low risk of progression to serious disease. Altimmune chief scientific officer Scot Roberts said: “These data suggest that a single intranasal vaccination with AdCOVID may provide sterilising immunity that neutralises infectious virus, which is believed to be the best way to block viral transmission. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. However, the effective rollout in the United States of authorized COVID-19 vaccines and decreasing incidence of disease significantly reduced the number of patients meeting these criteria, and Altimmune has been unable to enroll subjects in the final cohort. AdCOVID can potentially induce a wide immune response including systemic and local immunity in the nasal cavity and respiratory tract, the company said. Altimmune also provides an update on its T-COVID™Phase 1/2 Clinical Trial GAITHERSBURG, Md., June 29, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today provided an update on its AdCOVID investigational vaccine for the prevention of COVID-19. “The immune response to AdCOVID was inferior to that seen in our NasoVAX influenza vaccine trial,” commented Scot Roberts, PhD, Chief Scientific Officer at Altimmune. Choosing to participate in a study is an important personal decision. GAITHERSBURG, Md., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced … As a result of these enrollment challenges, the Company has decided to terminate further enrollment and evaluate options for future T-COVID development following an assessment of the available data and discussions with its partners, the U.S. Army Medical Research & Development Command (USAMRDC) and the Medical Technology Enterprise Consortium (MTEC). Taking stock of advances in clinical recognition, laboratory testing, and pharmacologic therapy as well as basic aspects of pathogenesis, the Third Edition of Heparin-Induced Thrombocytopenia reinforces its standing as the leading guide to ... In these cohorts, T-COVID was well tolerated without any serious adverse events observed. Altimmune’s candidate, administered through the nose, uses the same technology as the company’s influenza vaccine candidate, NasoVax, which recently completed phase 2 clinical trials. The immunogenicity data demonstrated lower than expected immune responses for each of the immune parameters tested. Currently, AdCOVID is being evaluated in a Phase I clinical trial for safety and immunogenicity of one or two intranasal doses given a month apart. Mucosal Vaccines is organized in a unique format in which basic, clinical, and practical aspects of the mucosal immune system for vaccine development are described and discussed. “The immune response to AdCOVID was inferior to that seen in our NasoVAX influenza vaccine trial,” commented Scot Roberts, PhD, Chief Scientific Officer at Altimmune. There are many principles and applications of recombinant antibodies for infectious diseases. The preferred technology associated to recombinant antibody generation is mainly phage display. Found inside – Page 395DensigenTM platform The DensigenTM platform (available from Altimmune) is based on rationally designed long, ... A Phase I clinical study with a densigen-based influenza vaccine demonstrated good immunogenicity to all six peptides ... “However, we are fortunate to have a strong pipeline with highly differentiated product candidates targeting indications of significant unmet need. “The commencement of our Phase 1 clinical trial of AdCOVID is an important milestone for our company and the global healthcare community in our fight against the SARS-CoV-2 virus,” said Dr. Scott Harris, Chief Medical Officer of Altimmune. Part 2 involves 12 doses of ALT-801, once a week for 12 weeks, as a SC injection and will be approximately 116 days in duration. In previous preclinical studies, the vaccine candidate demonstrated a 29-fold stimulation of spike-specific IgA and resident memory T-cell responses in the lungs of the animals tested. It is now widely acknowledged that at the beginning of this century Claude von Pirquet first pointed out that a viral disease, i. e. , measles, resulted in an anergy or depression of preexisting immune response, namely, delayed continuous ... Found insideThis book is intended to present current concepts in molecular biology with the emphasis on the application to animal, plant and human pathology, in various aspects such as etiology, diagnosis, prognosis, treatment and prevention of ... Altimmune anticipates having a full data readout from this Phase 1 study in Q2 2021. The first 2 cohorts were designed to assess the safety of T-COVID treatment and were comprised of COVID-19 infected patients 49 years or younger with a low risk of progression to serious disease. Altimmune also provides an update on its T-COVID™ Phase 1/2 Clinical Trial GAITHERSBURG, Md. Our pipeline includes next generation peptide therapeutics for obesity, NASH (ALT-801), and chronic hepatitis B (HepTcell™); proprietary intranasal vaccines; and an immune modulating therapeutic for COVID-19 (T-COVID™). Maryland-based clinical-stage biopharmaceutical firm Altimmune has announced that it will be discontinuing research into its intranasal COVID-19 vaccine following “disappointing” results.. This book provides a comprehensive overview of recent novel coronavirus (SARS-CoV-2) infection, their biology and associated challenges for their treatment and prevention of novel Coronavirus Disease 2019 (COVID-19). Part 1 involves a single dose of ALT-801 taken as a subcutaneous (SC) injection and will be approximately 36 days in duration. As a result of these enrollment challenges, the Company has decided to terminate further enrollment and evaluate options for future T-COVID development following an assessment of the available data and discussions with its partners, the U.S. Army Medical Research & Development Command (USAMRDC) and the Medical Technology Enterprise Consortium (MTEC). AdCOVID appeared to be well tolerated with an overall adverse event profile similar to intranasal saline placebo. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. AdCOVID appeared to be well tolerated with an overall adverse event profile similar to intranasal saline placebo. The 3rd cohort was intended to evaluate the efficacy of treatment and enroll patients over the age of 65 or with increased risk of serious sequelae by virtue of pre-existing comorbidities. Follow @Altimmune, Inc. on LinkedIn Subjects received either 1 or 2 doses of AdCOVID as a nasal spray at 3 dose levels. Follow @AltimmuneInc on Twitter. Found inside – Page 19814th Apr 2020 PM Narendra Modi extended nationwide lockdown till 3 May 22th Apr 2020 India stops rapid tests over ... Pre-clinical Johnson & Johnson Ad5-nCoV CanSino Biologics Phase 1 Tongji Hospital; Wuhan, China AdCOVID Altimmune ... Preclinical Development Services for the Pharmaceutical Industry, Customised Clinical Supply and Biological Sample Services, Software Solutions for Clinical Trial and Medical Research Project Management, The leading site for news and procurement in the clinical research industry, 11 May 2021 (Last Updated May 11th, 2021 11:56), I consent to Verdict Media Limited (publisher of Clinical Trials Arena) collecting my details provided via this form in accordance with the. The second edition of this book is virtually a new book. The company develops AdCOVID, a single-dose intranasal vaccine that is in Phase I clinical trial to protect against COVID … This book presents an integrated approach for sustained innovation in various areas of biotechnology. Based on these data, and in view of the highly competitive COVID-19 vaccine landscape, Altimmune is discontinuing further development of AdCOVID beyond the completion of this Phase 1 trial. Autoimmune diseases. Altimmune, Inc. announced Wednesday that it was approved by the FDA to begin Phase 1 clinical trials for AdCOVID, its single-dose nasal spray COVID-19 vaccine candidate. The FDA has put a planned phase 1 clinical trial of Altimmune’s intranasal COVID-19 vaccine on clinical hold. Whether we want to devise rational prophylactic or therapeutic vaccines or treatments to either prevent or treat mucosal infections we must acquire such knowledge. This is the rationale behind putting this book together. In these cohorts, T-COVID was well tolerated without any serious adverse events observed. Yesterday, Altimmune also announced it was awarded funding by the U.S. Army Medical Research & Development Command (USAMRDC) to fully support its T-COVID Phase 1/2 clinical trial in outpatients with early COVID-19 disease, making the COVID-19 therapeutic candidate the … GAITHERSBURG, Md., April 01, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported clinical data today on its NasoShield intranasal anthrax vaccine candidate. Displaying 11 studies . However, the effective rollout in the United States of authorized COVID-19 vaccines and decreasing incidence of disease significantly reduced the number of patients meeting these criteria, and Altimmune has been unable to enroll subjects in the final cohort. Tackling a complex topic in clear language, the book reveals the impressive scale of patenting, licensing, and spin-out company creation while demonstrating that university technology transfer is a commercial activity with benefits that go ... This volume, though, represents one of the first that specifically analyzes the relationship of new technologies to the teaching of languages for specific purposes (LSP), and, in doing so, makes an important contribution. Thinking about buying stock in Nabriva Therapeutics, WiMi Hologram Cloud, Xos Inc, Altimmune, or Penn National Gaming? Found insideCompany/Organization Gilead Sciences Clinical Research Organization, Dhaka, Bangladesh Inovio Altimmune Institut National de la Santé Et de la Recherche Médicale, France French National Agency for Research on AIDS and Viral Hepatitis ... The Ultimate Guide to Eating for Longevity is not a diet fad but based on the world’s long-standing civilizations that have changed very little over time and make it clear that it is possible to live a long healthy life. The Company is also filing clinical trial applications in Canada, Spain, Germany and the United Kingdom. Separately, Novavax reported that a combination of its Covid-19 vaccine candidate NVX-CoV2373 with quadrivalent seasonal flu vaccine NanoFlu led to immune responses against SARS-CoV-2 and influenza in a preclinical study. In a SARS-CoV-2 challenge model, a single dose of the vaccine delivered sterilising immunity in the lungs of mice, while non-vaccinated mice went on to develop dense lung infection and disease. Found inside – Page 2STATUS: Altimmune said February 28 that it completed the design and synthesis of the vaccine, and was advancing it toward animal testing and manufacturing. Clinical testing of the vaccine could start as early as August. The Phase 1b trial evaluated the safety and immunogenicity of one and two-dose regimens of NasoShield in healthy volunteers. Found insideIntegrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014â€"2015 epidemic and makes recommendations about how the conduct of trials could be improved in the ... The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. News provided by. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Talk with your doctor and family members or friends about deciding to join a study. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: potential impacts due to the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to obtain potential regulatory approvals on the timelines anticipated; the success of future product advancements, including the success of future clinical trials; and funding delays, reductions in or elimination of U.S. government funding with USAMRDC. Altimmune is a clinical stage biopharmaceutical company focused on developing treatments for obesity and liver disease and intranasal vaccines. This detailed new edition provides a comprehensive collection of protocols applicable to all members of the Coronavirinae sub-family currently and that are also transferrable to other fields of virology. Each participant will enroll in only one part. Is it possible to double or triple your money on buying stocks? Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has completed enrollment in its Phase 1b clinical trial of NasoShield, a single dose intranasal anthrax vaccine candidate. Altimmune also provides an update on its T-COVID™ Phase 1/2 Clinical Trial. InvestorsObserver Sep 08, 2021, 09:31 ET. In addition to the primary study endpoint of safety and tolerability, the immunogenicity evaluation of AdCOVID included serum binding and neutralizing antibody titers and mucosal IgA antibody from nasopharyngeal swabs post-vaccination. Talk with your doctor and family members or friends about deciding to join a study. No. In The Great American Drug Deal, Peter Kolchinsky offers clear-eyed analysis, compelling stories, and vital ideas for closing loopholes, dealing with bad actors, supporting patients, and fueling discoveries that ease suffering now and ... When health crises strike—measles, MERS, Zika, dengue, Ebola, pandemic flu—and the American people grow alarmed, the U.S. government springs into action. Follow @Altimmune, Inc. on LinkedInFollow @AltimmuneInc on Twitter. Browse Clinical Trials. Powered by Madgex Job Board Software. Altimmune will discontinue further development of AdCOVID and focus its resources on its ongoing obesity and liver programs. All rights reserved. Found inside – Page 239... VLPs Pre-clinical (human trial to begin by end of 2020) Pre-clinical Pre-clinical Pre-clinical Pre-clinical Pre-clinical ... Developer/Researcher Geovax/ Bravovax Altimmune / Alabama University Non-replicating viral vector (AdCOVID) ... The Company also provided an update on its T-COVID Phase 1/2 clinical trial to evaluate the potential of T-COVID to prevent clinical worsening in patients with early COVID-19. For general information, Learn About Clinical … GAITHERSBURG, Md., June 29, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today provided an update on its AdCOVID investigational vaccine for the prevention of COVID-19. We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID.”, “The top-line Phase 1 clinical data are disappointing given the encouraging preclinical data and our substantial efforts in advancing a differentiated, intranasal vaccine candidate in the fight against COVID-19,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. Although antibodies were detected that bound the SARS-CoV-2 Spike protein and neutralized the virus in a subset of subjects, the magnitude of the response and the percent of subjects responding to AdCOVID were substantially lower than what had been demonstrated for other vaccines already authorized for emergency use. Chief Financial Officer                                                  Will Brown                                                         Found insideThis book presents topics ranging from the basic biology of adenoviruses, through the construction and purification of adenoviral vectors, cutting-edge vectorology, and the use of adenoviral vectors in preclinical animal models, with final ... Altimmune also provides an update on its T-COVID™ Phase 1/2 Clinical Trial GAITHERSBURG, Md., June 29, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today provided an update on its AdCOVID investigational vaccine for the prevention of COVID-19. Altimmune anticipates reporting data from this trial next month. The next chapter of clinical trial services, Keen Eye introduces AI-powered platform to support clinical trials, Horizon begins subject recruitment in thyroid eye disease medicine trial, BerGenBio concludes subject enrolment in Phase II AML drug trial, Southern Cross University initiates trial of CBD for sleep disturbances. Suite 201-S For each possible adverse event, the report reviews peer-reviewed primary studies, summarizes their findings, and evaluates the epidemiological, clinical, and biological evidence. , June 29, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today provided an update on its AdCOVID investigational vaccine for the prevention of COVID-19. The Phase 1 AdCOVID clinical trial is evaluating the safety and immunogenicity of the intranasally administered vaccine candidate in approximately 80 healthy adult volunteers between the ages of 18 and 55. Immunopotentiators in Modern Vaccines provides an in-depth insight and overview of a number of most promising immunopotentiators in modern vaccines. This comprehensive volume compiles the concepts essential for the understanding of the pharmaceutical science and technology associated with the delivery of subunit vaccines. Altimmune anticipates reporting data from this trial next month. The 3rd cohort was intended to evaluate the efficacy of treatment and enroll patients over the age of 65 or with increased risk of serious sequelae by virtue of pre-existing comorbidities. Altimmune is a clinical stage biopharmaceutical company focused on developing treatments for obesity and liver disease and intranasal vaccines. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. Who killed United States Senator Frank Boudreau with an ice pick? The company's cash burn rate will probably rise a great deal in 2021 as more clinical trials with ALT-801 as a treatment for different patient groups begin. The sterilising immunity showed by AdCOVID in this study is comparable to the vaccine candidate’s induction of local and systemic immunity in earlier animal studies, Altimmune noted. For general information, Learn About Clinical … Although antibodies were detected that bound the SARS-CoV-2 Spike protein and neutralized the virus in a subset of subjects, the magnitude of the response and the percent of subjects responding to AdCOVID were substantially lower than what had been demonstrated for other vaccines already authorized for emergency use. In the study, carried out in partnership with the University of Alabama at Birmingham, K18-hACE2 transgenic mice were given a single intranasal dose of AdCOVID and challenged with live SARS-CoV-2 after a month. “Unlike the NasoVAX study, the AdCOVID study population lacked immunity from prior infection or vaccination. Phone: 240-654-1450                                                         The Company also provided an update on its T-COVID Phase 1/2 clinical trial to evaluate the potential of T-COVID to prevent clinical worsening in patients with early COVID-19. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. Or vaccination one and two-dose regimens of NasoShield in healthy volunteers integrated approach for sustained innovation in various of! Doctor may contact the study altimmune clinical trials staff using the contacts provided below these forward-looking statements subject... Treatments for obesity and liver programs generation of plants as production platforms for biopharmaceuticals, book! Population lacked immunity from prior infection or vaccination the understanding of the manner in which American presidents to... These forward-looking statements are subject to numerous assumptions, risks, and,! 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