(BOSTON, MA) –– CARB-X, a global partnership led by Boston University, is awarding Integrated Biotherapeutics (IBT) of Rockville, Maryland, USA, $1.6 million to expand the development of its vaccine against Staphylococcus aureus, including Methicillin-resistant Staphylococcus aureus (MRSA) superbugs, so that the vaccine can be used to prevent infections in developing nations, as well as in the developed world. Under this initiative, IBT will expand its R&D to evaluate the efficacy of its vaccine, IBT-V02, against strains of the bacteria found in developing nations, and will also explore development of a freeze-dried version of the vaccine so that it can be used where cold storage systems are not available.
IDWeek 2019 Annual Conference
October 2 – October 6
Attendees include Richard Alm, CARB-X Alliance Director.
IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medical Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS).
IBT in collaboration with the laboratory of Dr. Yuxing Li, at the University of Maryland, and Dr. Tom Geisbert laboratory and University of Texas Medical Branch (UTMB) receive a collaborative SBIR grant from NIH, entitled Monoclonal antibodies targeting novel sites of vulnerability in marburg virus glycoprotein.
Marburg virus has caused highly lethal outbreaks in the last few decades. Currently there is only a single class of antibodies known to neutralize marburgviruses. Under this grant IBT investigator Dr. M. Javad Aman with work with Dr. Li’s team to develop novel monoclonal antibodies from B cells of macaques immunized with IBT’s proprietary vaccine candidates. These antibodies will be tested in rodents and nonhuman primates at UTMB to select lead therapeutic candidates.
IBT in collaboration with Dr. Daniel Nelson’s lab at Institute for Bioscience and Biotechnology Research, University of Maryland received a collaborative Phase II STTR grant from NIH, entitled Infection Site Targeted Antitoxin Antibody (ISTAb) against Bacillus anthracis
This Phase II Project builds upon successfully completed Phase I studies that showed proof of concept for a highly promising therapeutic strategy. This strategy is based on a novel technology that uses Infection Site Targeted neutralizing anti-toxin Antibodies (ISTAb) that are directed to the site of B. anthracis infection. In this Phase II project, Dr. Adhikari of IBT and collaborators will select a final product candidate based on the efficacy studies in mouse and NHP, as well as extended PK and stability studies. Work under this project further includes computer-aided optimization of the lead ISTAb candidates and selection based on efficacy in rodents and nonhuman primates, as well as analytical development.
IBT in collaboration with the laboratory of Dr. Brandon Dekosky, at the University of Kansas, and Dr. Tom Geisbert laboratory and University of Texas Medical Branch (UTMB) receive a collaborative SBIR grant from NIH, entitled Mining natively paired macaque antibodies for Marburg virus protective antibodies.
Marburg virus has caused highly lethal outbreaks in the last few decades. Currently there is a paucity of immunotherapeutic options in the pipeline for treatment of this deadly diseases. Under this grant IBT investigator Dr. Shweta Kailasan with work with Dr. Dekosky’s team to develop novel monoclonal antibodies using a new method for identification of natively paired heavy and light chains from B cells of macaques immunized with IBT’s proprietary vaccine candidates. These antibodies will be tested in rodents at UTMB to select lead therapeutic candidates.
IBT in collaboration with Abviro, LLC (Bethesda, MD) received a collaborative SBIR grant from NIH, entitled Development of a Universal Immunotherapeutic for Influenza Viruses.
Influenza virus (INFV) results in global seasonal and pandemic outbreaks estimated to cause severe illness in 3 to 5 million people annually causing significant morbidity and economic impact. Vaccination is currently the most effective disease control intervention, but constant annual surveillance of circulating viruses is necessary to predict effective vaccine composition. Currently available influenza drugs only result in modest clinical efficacy with limited effectiveness due to viral resistance.
In this fast track SBIR IBT and Abviro will perform advanced development activity for the lead product 3I14 as broad-spectrum antibody therapeutic against multiple influenza A strains. In phase I, we will establish a highly productive stable CHO Research Cell Bank and generate a characterized stable lot of 3I14 to support phase II objectives. Phase II will characterize the 3I14 dose response in INFV A mouse models and therapeutic window, establish the pharmacokinetics and tolerability of 3I14 in mice, and confirm 3I14 does not lose potency as a result of viral resistance. Completion of these studies will position the product for IND-enabling manufacturing, efficacy and toxicology studies necessary to advance 3I14 to clinical studies.
IBT in collaboration with Dr. Jean Lee lab at Brigham and Women Hospital, Harvard University, received a collaborative SBIR grant from NIH, entitled ISTAb: A novel therapy to target staphylococcal toxins at the site of infection.
Staphylococcus aureus (SA) is a Gram-positive human pathogen that causes a wide range of diseases from skin and soft tissue infections (SSTI) to life threatening sepsis and pneumonia. Numerous virulence factors, including cell surface proteins and polysaccharides, as well as secreted toxins are involved in SA pathogenesis. The cytolytic toxins kill key immune cells, allowing the pathogen to evade the immune response, induce tissue damage, and promote bacterial dissemination and metastatic growth in distant organs. There are currently no vaccine or immunotherapeutics against S. aureus.
In this Phase I SBIR, led by Dr. Rajan P. Adhikari, we will target neutralizing anti-toxin antibodies to the site of SA infection by taking advantage of the cell wall targeting (CWT) domain of lysostaphin (lyso) that specifically binds to the SA cell wall. The isolated CWT domain will be fused to specific anti-toxin monoclonal antibodies (mAbs) to generate Infection Site Targeted anti-toxin Antibodies (ISTAbs). A number of engineered candidates will be produced and tested in animal models of S. aureus invasive disease to select a preclinical candidate therapeutic.