Clarametyx’s biologic therapy breaks down the biofilm shield that protects bacteria, allowing antibiotics and the body’s immune system to attack bacteria causing infection
(BOSTON) – CARB-X is awarding up to US$2.42 million to Clarametyx Biosciences, based in Columbus, Ohio, USA, to develop a new treatment for serious bacterial biofilm infections, including those such as pneumonia caused by antibiotic-resistant ESKAPE pathogens and polymicrobial biofilms. Clarametyx will be eligible for an additional $11.85 million in non-dilutive funding from CARB-X if project milestones are met, subject to available funds.
Clarametyx’s pioneering therapy, CMTX-101, is a monoclonal antibody designed to rapidly collapse bacterial biofilms – protective shields that coat bacterial pathogens and help make them resistant to the effects of antibiotics and immune response. CMTX-101 targets a region of DNABII binding proteins that are essentially identical across all pathogenic bacteria. Bacterial DNABII proteins stabilize and maintain the integrity of bacterial biofilms. Precisely targeting this region on the DNABII proteins rapidly collapses biofilms, rendering the bacteria more vulnerable to the effects of antibiotics and the immune system.
Bacterial biofilms are highly resistant to antibiotics and can grow on medical devices and human tissues. Biofilm bacterial infections are increasingly difficult to treat as conventional antibiotics cannot penetrate the protective shield. Bacterial biofilms are responsible for an estimated 80 percent of infections in the human body including most hospital-acquired infections, bacterial pneumonia, chronic lung infections, and chronic wound-related infections. A bloodstream infection can, for example, be caused by the biofilm initially formed on medical implants, such as heart valves or joint prostheses, or on medical devices such as catheters. These infections are associated with significant morbidity and mortality.
Targeting DNABII proteins has demonstrated effectiveness against a broad range of bacteria, including ESKAPE pathogens (six pathogens with growing multidrug resistance and virulence: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp. The World Health Organization (WHO) identifies these as priority bacterial threats.
“Bacterial biofilms are a serious global health concern due to their ability to resist both antibiotics and the host’s immune system,” said Erin Duffy, R&D Chief of CARB-X, a non-profit global partnership led by Boston University and dedicated to supporting the development of innovative products to address antibiotic-resistant bacterial infections. “We urgently need new therapeutics to address life-threatening bacterial infections. Clarametyx is developing an exciting new approach that could be effective against a broad range of serious drug-resistant pathogens and also numerous types of infections.”
“The CARB-X funding award recognizes the clinical potential of this important technology. With an entirely new approach to persistent bacterial infections, our technology could represent a disruptive innovation that is very well aligned to the CARB-X goals to combat drug resistance,” said Charles McOsker, Ph.D., co-founder and Chief Scientific Officer of Clarametyx. “The funding and technical expertise offered by CARB-X will fuel momentum in our pre-clinical development to pursue this powerful new solution for life-threatening infections that contribute considerable burden to the global community.”
Supporting global antibacterial innovation to address drug resistance
The WHO estimates that 700,000 people die each year from drug-resistant infections, including 35,000 in the US and 33,000 in Europe. CARB-X funds only projects that target drug-resistant bacteria highlighted on the Centers for Disease Control and Prevention (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.
The CARB-X portfolio is the world’s largest and most diverse antibacterial R&D portfolio with 47 active projects focused exclusively on drug-resistant bacteria. CARB-X is investing up to $480 million in non-dilutive funding between 2016-2022 to support the early development of new antibiotics, vaccines, rapid diagnostics and other life-saving products. The goal is to support therapeutics 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 73 awards worth $259.6 million, with the potential of additional funds 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 others fail for a variety of reasons.
This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from the Wellcome Trust and Germany’s Federal Ministry of Education and Research (BMBF). 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.
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, 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 investing up to $480 million from 2016-2022 to support innovative antibiotics and other therapeutics, vaccines, 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.
About Clarametyx Biosciences
Clarametyx Biosciences is combating the formidable challenge of persistent and recalcitrant infections through an innovative technology platform targeting the biofilm—a protective layer around bacteria—to enable a more effective immune response or antibiotic intervention. The Columbus, Ohio-based company is building a dynamic pipeline of immune-enabling therapies and vaccines for life-threatening bacterial infections associated with biofilms. Its lead candidate, CMTX-101, is a humanized monoclonal antibody in preclinical development for hospital-acquired pneumonia. For more information, visit us on the web or on LinkedIn.
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).
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.