Multidrug-resistant K. pneumoniae is a leading cause of life-threatening infections, including hospital-acquired and ventilator-associated pneumonia
(BOSTON) – CARB-X announced today it is awarding up to US$2.5 million to GangaGen Biotechnologies, headquartered in Bangalore, India, to develop novel antibacterial proteins, called klebicins, to treat pneumonia caused by Klebsiella pneumoniae, a difficult-to-treat bacteria belonging to the Enterobacterales family of Gram-negative pathogens. GangaGen will be eligible for an additional $8.1 million in funding from CARB-X if project milestones are met, subject to available funds.
“GangaGen is researching a highly innovative approach to treat infections caused by multidrug-resistant K. pneumoniae, including the carbapenem-resistant and Extended-Spectrum β-Lactamase (ESBL)-expressing strains of particular clinical concern,” said Erin Duffy, R&D Chief of CARB-X, a global partnership led by Boston University dedicated to supporting the development of antibacterial products to diagnose, prevent and treat drug-resistant infections. “The project is in the early stages of development and if successful, it could represent progress in the treatment of multidrug-resistant bacterial infections.”
K. pneumoniae presents a serious health challenge around the world and is of increasing concern in low- and middle-income countries (LMICs), where it causes life-threatening infections such as pneumonia and neonatal sepsis. CARB-X funding for the project comes from the U.S. Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services; the Wellcome Trust in the UK; the UK Global Antimicrobial Resistance (AMR) Innovation Fund (GAMRIF), and Germany’s Federal Ministry of Education and Research (BMBF). In addition to supporting project development, funding will also support collaboration with academic institutions and hospital-based research institutions in India to address the susceptibility of people living on the Asian Subcontinent to K. pneumoniae.
Highlighting the UK government’s contribution, UK’s Acting High Commissioner to India, Jan Thompson, said: “This award is a great example of UK’s role in global collaboration in research and development. The CARB-X award to Indian clinical-stage biotechnology company, GangaGen, partially funded by the UK’s Global AMR Innovation Fund, will help to tackle some of the world’s most serious issues. We hope that this research will help to combat the ‘silent pandemic’ of AMR.”
Tanjore S Balganesh, President of GangaGen Biotechnologies, said: “We are delighted to receive CARB-X’s support to progress the klebicin programme. K. pneumoniae is a hard-to-treat pulmonary pathogen resistant to many of the current antibiotics. Additionally, hypervirulent strains of the pathogen are being isolated in many parts of the globe.”
GangaGen is developing klebicins, which are naturally occurring protein antibiotics, as precision agents to target K. pneumoniae. Klebicins’ novel mechanism of action enables specific killing of the target pathogen without impacting the microbiome. Klebicins have shown potent activity against K. pneumoniae in in vivo studies. The CARB-X award will support further discovery, protein engineering and development of potent klebicins for the treatment of hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) caused by K. pneumoniae.
Vivek Daniel Paul, GangaGen’s Principal Investigator said: “The klebicin molecules have a novel mode of action and represent a unique opportunity to discover, design and develop novel antibacterials. We look forward to progressing these molecules.”
New approaches urgently needed to address drug-resistant bacteria
The World Health Organization (WHO) estimates that 700,000 people die each year from drug-resistant infections. CARB-X funds only projects that target drug-resistant bacteria highlighted on the CDC’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list.
CARB-X currently funds and supports 43 active projects. CARB-X is investing up to $480 million in non-dilutive funding between 2016-2022 to support the early development of new therapeutics, preventatives and rapid diagnostics. 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 regulatory approval for use in patients.
Since its launch in 2016, CARB-X has announced 69 awards worth $252 million, with the potential of additional funding if project milestones are met. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and graduate, and others fail for a variety of reasons.
The research referenced in this news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from Wellcome Trust, Germany’s Federal Ministry of Education and Research (BMBF) and the UK Global Antimicrobial Resistance (AMR) Innovation Fund (GAMRIF). The contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Office of the Assistant Secretary for Preparedness and Response, or other CARB-X funders.
Tanjore S Balganesh, President
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global non-profit partnership dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for 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, 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 investing up to $480 million from 2016-2022 to support innovative antibiotics and other therapeutics, vaccines and other prevention approaches, and rapid diagnostics. CARB-X supports the world’s largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X is headquartered at Boston University School of Law. carb-x.org/. Follow us on Twitter @CARB_X.
GangaGen Biotechnologies (GBPL) is a wholly owned subsidiary of Bactoclear Holdings, Singapore. The company is designing and developing novel Protein Antibiotics for the treatment of bacterial infections in the high unmet medical need area of antimicrobial resistance (AMR). The current programmes focus on Methicillin Resistant Staphylococcus aureus (MRSA), Klebsiella pneumoniae and Acinetobacter baumannii, all of which are included in the WHO priority list of pathogens. Using a proprietary bioinformatics driven platform technology, novel protein antibacterials, Ectolysins® and Bacteriocins have been designed and tested. These are recombinantly expressed precision antibacterial proteins with novel mechanisms of action that rapidly kill targeted pathogens without altering the microbiome. The GangaGen portfolio includes a variety of such molecules targeting both Gram-positive and Gram-negative bacteria. More information can be found at www.gangagen.com and LinkedIn. https://www.linkedin.com/company/gangagen.
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. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 55 BARDA-supported products have achieved FDA approval, licensure or clearance. 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 the German 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.
This research is co-funded by DHSC’s Global AMR 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 antimicrobial resistance (AMR). GAMRIF supports 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 firstname.lastname@example.org. www.bu.edu.