New alternative-to-antibiotic treatment in development to fight infections associated with E. coli superbug
(BOSTON: July 31, 2019) – CARB-X, a global partnership led by Boston University, is awarding BB100 LLC, a subsidiary of Bravos Biosciences of Schenectady, New York, USA, up to $3.0 million in non-dilutive funding with the possibility of up to $6.2 million more if certain project milestones are met, to develop a novel monoclonal antibody to prevent or treat serious life-threatening infections caused by a particularly virulent strain of Gram-negative multi-drug-resistant Escherichia coli (E. coli) called ST131-025b, which is often associated with complicated urinary tract, bloodstream, and prostate infections.
“CARB-X continues to increase the number of innovative R&D approaches we support to combat drug-resistant bacteria,” said Kevin Outterson, Executive Director of CARB-X and Professor of Law at Boston University. “Patients urgently need new life-saving products and the BB100 approach represents a potential alternative to antibiotics to treat serious infections.”
“We are very excited and appreciative of the CARB-X award.” says Christopher Rubino, PharmD, President of Bravos. “CARB-X support greatly enhances our ability to advance BB100, which holds the promise to be both life-saving and decrease our societal reliance on antibiotics prone to resistance.”
CARB-X funding will support Investigational New Drug (IND) enabling studies, drug manufacturing and the conduct of a Phase 1 clinical study. While still in preclinical development, if approved by regulatory authorities for use in patients, BB100 has the potential to transform the treatment of E. coli infections as it side-steps antibiotic resistance mechanisms.
E. coli bacteria are a frequent cause of cholecystitis, cholangitis, bacteremia, urinary tract and intra-abdominal infections, traveler’s diarrhea, pneumonia and neonatal meningitis. E. coli can be difficult to treat because of emerging antibiotic resistance. Multi-drug resistant E. coli is the world’s most prevalent superbug and is associated with significant morbidity and mortality. Hospitalized patients whose care requires devices like urinary catheters or intravenous catheters are particularly vulnerable.
Driving innovation to address the growing global superbug crisis
According to the World Health Organization, an estimated 700,000 people die each year worldwide from bacterial infections. In the United States alone, an estimated 23,000 people die each year from drug-resistant bacterial infections. In Europe, the number of deaths yearly is estimated at 33,000.
The CARB-X portfolio, the world’s largest antibacterial development portfolio with 30 projects in five countries, is expected to grow significantly this year. Since its inception in 2016, CARB-X has announced awards exceeding $130.5 million, with the potential of additional funds if project milestones are met, to accelerate the development of antibacterial products. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and graduate from CARB-X and others fail for a variety of reasons. In total since it was established, CARB-X has announced awards for 45 projects.
Partnership driving antibacterial innovation
CARB-X is investing more than $500 million in antibacterial R&D between 2016-2021. The goal is to support projects through the early phases of development through Phase 1, so that they will attract additional private or public support for further clinical development and approval for use in patients. CARB-X funding is restricted to projects that target drug-resistant bacteria highlighted on the Centers for Disease Control and Prevention (CDC)’s 2013 Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO in 2017 – with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list.
Part of CARB-X’s award for BB100 will come from funds provided by the UK Government’s Global AMR Innovation Fund (GAMRIF). GAMRIF is an Official Development Assistance (ODA) fund which allocates support for projects that promote the welfare and economic development of low- and middle-income countries (LMICs). BB100’s antibody acts against E. coli ST131-025b, a pathogen identified in LMICs which causes resistant infections across Asia, South America and Africa. BB100 has the potential to side-step resistance mechanisms, and as a single dose, could be relatively easy and inexpensive to administer. This is particularly relevant to fighting infection in low-resourced settings.
CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the US Department of Health and Human Services , the Wellcome Trust, a global charity based in the UK working to improve health globally, Germany’s Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). CARB-X is headquartered at the Boston University School of Law.
This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and awards from Wellcome Trust, the German Federal Ministry of Education and Research, and the Global AMR Innovation Fund (GAMRIF) funded by the UK Government Department of Health and Social Care (DHSC), as administrated by CARB-X. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Department of Health and Human Services Administration for Strategic Preparedness and Response, other funders, or CARB-X.
CARB-X is a global non-profit partnership led by Boston University and dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the US Department of Health and Human Services , the Wellcome Trust, a global charity based in the UK working to improve health globally, Germany’s Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (UK GAMRIF), the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). A non-profit partnership, CARB-X is investing more than $500 million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, rapid diagnostics and devices. CARB-X supports the world’s largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X focuses exclusively on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X is headquartered at Boston University School of Law. https://carb-x.org/. Follow us on Twitter @CARB_X.
About Bravos Biosciences
Bravos Biosciences, through its subsidiary, BB100, LLC is currently advancing its novel monoclonal antibody, BB100, into IND enabling studies. Bravos is an emerging biotechnology company focused on developing novel, transformational anti-infective therapies for the prevention and treatment of multi-drug resistant infections. Bravos is led by an experienced team of anti-infectives experts seeking to improve outcomes for patients with multi-drug resistant and other difficult-to-treat infections. Bravos is located in Schenectady, NY.
About BARDA and NIAID
The US Department of Health and Human Services works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. Within HHS, ASPR’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. BARDA provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases. NIH is the primary US federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.
About Wellcome Trust
Wellcome exists to improve health for everyone by helping great ideas to thrive. We’re a global charitable foundation, both politically and financially independent. We support scientists and researchers, take on big problems, fuel imaginations and spark debate. The Wellcome Trust is a charity registered in England and Wales, no. 210183. Its sole trustee is The Wellcome Trust Limited, a company registered in England and Wales, no. 2711000 (whose registered office is at 215 Euston Road, London NW1 2BE, UK).
Education and research are the foundations for our future. The promotion of education, science and research by Germany’s Federal Ministry of Education and Research (BMBF) represents an important contribution to securing Germany’s prosperity. Education and research are a Federal Government policy priority, which is reflected in the development of the funding it is making available to these fields.
About the Global AMR Innovation Fund (GAMRIF)
The Department for Health and Social Care (DHSC) is the UK Government department which is responsible for helping people to live more independent, healthier lives for longer.
The partnership with CARB-X is part of DHSC’s Global Antimicrobial Resistance Innovation Fund (GAMRIF). GAMRIF was established to provide seed funding for innovative research and development, specifically in neglected and underinvested areas, in the field of AMR. GAMRIF is a £50m UK Aid investment, which means all projects funded must support research primarily and directly for the benefit of people in low- and middle-income countries (LMICs). The Fund takes a ‘One Health’ approach, seeking to invest in potential solutions to reduce the threat of AMR in humans, animals, fish and the environment. The Fund seeks to leverage additional global funding through interaction with international government bodies, public-private partnerships, product development partnerships, global funding mechanisms and global fora.
About Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With more than 33,000 students, it is the fourth-largest independent university in the United States. BU consists of 17 schools and colleges, along with a number of multi-disciplinary centers and institutes integral to the University’s research and teaching mission. In 2012, BU joined the Association of American Universities (AAU), a consortium of 62 leading research universities in the United States and Canada. For further information, please contact Jeremy Thompson at email@example.com. www.bu.edu.