Study is expected to provide insights into mechanisms of protection against staph infection. IBT and its subsidiary Integrated BioTherapeutic Vaccines (IBV) are developing IBT-V02, a novel vaccine for S. aureus infections with support from CARB-X and Novo Holdings. IBT-V02 will enter Phase 1 clinical trial this year.
ROCKVILLE, Md., March 24, 2022 /PRNewswire-PRWeb/ -- Integrated BioTherapeutics Inc. (IBT), a Maryland biotechnology company specializing in emerging infectious diseases, announced today the receipt of a research grant of $3.55 million over 5 years from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The primary objective of the grant is to conduct a prospective clinical study of patients infected with Staphylococcus aureus (S. aureus or "staph"), including methicillin-resistant S. aureus (MRSA), to determine risks of recurrent infection, and immunological correlates of protection. The clinical study will be performed at the Olive View-UCLA emergency department, an affiliate of The David Geffen School of Medicine at UCLA. There are millions of cases of staphylococcal infections in the United States and around the world, which cause a significant disease burden in terms of morbidity and mortality. To date, efforts to develop a vaccine against staph have been unsuccessful in large part due to a lack of understanding of the mechanisms of protection against this dangerous pathogen.
"Staph skin infections, particularly those caused by the drug-resistant MRSA strains, lead to widespread suffering and disability, and in their most serious form, exact a deadly toll when they lead to bloodstream infections and sepsis. Unfortunately, we know very little about the nature of a protective immune response in humans," said Dr. M. Javad Aman, Chief Scientific Officer of IBT and the study's Principal Investigator. "The award of this grant is a crucial step toward understanding the mechanisms of protection that can guide us toward successful development of an effective vaccine."
IBT and its subsidiary Integrated BioTherapeutic Vaccines (IBV) are working to develop a novel vaccine for S. aureus (IBT-V02) with support from CARB-X and Novo Holdings. The vaccine is scheduled to enter Phase 1 clinical trial this year. The NIAID grant will help the company generate data to inform future clinical trials to assess vaccine efficacy.
"Following the discovery of the emergence of the invasive MRSA strains as the predominant cause of skin infections in the US, and later trials in which we identified the most effective antibiotic treatments, our group's final goal is to determine how these infections can be prevented altogether," said Dr. David Talan, the study's clinical Principal Investigator and Professor Emeritus of Medicine/Infectious Diseases and Emergency Medicine and emergency physician at Ronald Reagan UCLA Medical Center.
The prospective clinical study is funded by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under award number R01AI111205. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About Integrated BioTherapeutics:
IBT develops vaccines and immunotherapies for bacterial and viral infectious diseases. The Company's lead vaccine product, IBT-V02 is a first-in-class multi-component vaccine against Staphylococcus aureus.
Supported by CARB-X and by Novo Holding's Repair Impact Fund, IBT-V02 is currently undergoing cGMP manufacturing and IND-enabling studies, with initiation of clinical trials anticipated in late 2022. IBT and its subsidiary IBV (http://www.integratedbiotherapeuticvaccines.com) immunotherapeutic pipeline includes monoclonal antibodies for the treatment of the array of viruses that cause hemorrhagic fever. IBT also is developing product candidates for the treatment of S. aureus, anthrax, and Clostridium difficile, based on its proprietary Infection Site Targeted Antitoxin Antibody (ISTAb) technology. Learn more about IBT's pipeline at https://www.integratedbiotherapeutics.com/our-science/.
Media Contact
Haimi Shiferaw, Integrated Biotherapeutics Inc., +1 240-778-6513, [email protected]
SOURCE Integrated Biotherapeutics Inc.
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