Clarametyx vaccine aims to prevent biofilm-associated infections that are highly resistant to antibiotics
(BOSTON: January 7, 2025) – Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award Clarametyx Biosciences US$2.6 million to develop a Lead Optimization workplan to support its novel broad-spectrum, anti-biofilm vaccine program. Preclinical and Phase 1 clinical evaluation work plans may be considered for future awards with successful completion of milestones and continued programmatic interests.
Clarametyx is developing CMTX-301, a pathogen-agnostic anti-biofilm vaccine candidate designed to prevent bacterial biofilm formation and allow the body’s natural immune response to clear infections. The CARB-X award will advance CMTX-301 from Lead Optimization stage to Preclinical (IND) evaluation. If successful, immunization with CMTX-301 to prevent the occurrence of biofilm-associated infections may decrease the need for antibiotic therapy and thus decrease the threat of resistance development.
Bacterial biofilms are the bacteria’s greatest defense mechanism against host immune effectors and antibiotics, responsible for 80% of bacterial infections, and a known contributor to antimicrobial resistance. Biofilms represent a significant challenge to delivering safe effective medical procedures for patientsincreasing bacteria tolerance to antibiotics up to 1000-fold.
Biofilms enable bacteria to infect medical devices and human tissues shielding bacteria from natural clearance mechanisms. Bacterial biofilms are increasingly recognized to be involved in clinical infections in many body systems including the auditory, the cardiovascular, the digestive, the integumentary, the reproductive, the respiratory, and the urinary system. Biofilms initially formed on medical implants, such as heart valves or joint prostheses, or on medical devices such as catheters, can lead to bloodstream infections which are associated with significant morbidity and mortality. Immunization with CMTX-301 targets the critical structural lattice of the biofilm, preventing the formation of the biofilm and thereby reduces and clears bacterial infections without the use of antibiotics.
“CARB-X is proud to continue supporting Clarametyx Biosciences in work to combat biofilm-associated infections, a major challenge in the fight against antibiotic resistance,” said Erin Duffy, PhD, R&D Chief of CARB-X. “With their novel anti-biofilm vaccine, CMTX-301, Clarametyx is taking an innovative approach that could transform how we prevent and treat these difficult-to-address infections. We look forward to seeing the impact of this program as it advances through clinical development.”
This is the second award CARB-X has provided to support Clarametyx’s work on novel anti-biofilm technologies. In 2020, CARB-X funded Clarametyx to advance CMTX-101 to clinical evaluation. CMTX-101 targets the scaffolding protein in biofilms and is intended to be used in combination with antibiotics to effectively treat bacterial infections. The new award will support advancement of CMTX-301. This candidate targets the same scaffolding machinery of the biofilm, however, is designed to prevent biofilm formation to reduce and clear bacterial infection and reduce the need for antibiotic intervention.
“We are extremely grateful for the opportunity to collaborate with CARB-X, a world leader in R&D efforts to address antimicrobial resistance,” said David V. Richards, CEO of Clarametyx Biosciences. “Together we aim to pursue a novel vaccine strategy to undermine bacterial defenses and enable natural clearance of bacteria, reducing the need for anti-bacterial therapies.”
In March 2024, CARB-X launched a new funding solicitation to fill major R&D gaps in the global antibiotic development pipeline. More than 300 Expressions of Interest were accepted in four distinct product themes: therapeutics for infections caused by Gram-negative pathogens, prevention of invasive disease, diagnostics for neonatal sepsis, and proof-of-concept for novel sample types for diagnosing lower-respiratory tract infections. Additional projects are under review, and new awards will be announced later this year. Register for the CARB-X newsletter to learn about upcoming funding calls that will be announced in 2025.
When CARB-X was founded in 2016, the early-stage antibiotic pipeline was stalled. Since its inception, CARB-X has supported 105 R&D projects in 13 countries, and CARB-X product developers have made significant progress: 18 projects have advanced into or completed clinical trials; 12 remain active in clinical development, including late-stage clinical trials; and two diagnostic products have reached the market. Additionally, at least 9 product developers with active R&D projects have already secured advanced development partnerships to support their clinical development after leaving the CARB-X portfolio. All CARB-X-funded product developers are contractually obligated to develop a Stewardship and Access Plan for their product, outlining strategies to ensure responsible stewardship and appropriate access in low- and middle-income countries.
CARB-X is funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under agreement number 75A50122C00028 and by awards from Wellcome (WT224842), 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 Public Health Agency of Canada (PHAC), the Bill & Melinda Gates Foundation, and the Novo Nordisk Foundation. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of any CARB-X funders.
CARB-X Contact: Marissa Novel, carbxpr@bu.edu
Clarametyx Contact: Kellie Hotz, khotz@clarametyx.com
About CARB-X
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventatives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. 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. https://carb-x.org/ | X (formerly Twitter) @CARB_X
About Clarametyx
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 and antibiotic intervention. The Columbus, Ohio-based company is building a pipeline of immune-enabling therapies and vaccines for serious bacterial infections associated with biofilms, with a near-term focus on chronic respiratory diseases. For more information, visit us on the web or on LinkedIn.
About BARDA and NIAID
The U.S. 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. The Administration for Strategic Preparedness and Response (ASPR) leads the nation’s medical and public health preparedness for, response to and recovery from disaster and other public health emergencies. Within ASPR, the Biomedical Advanced Research and Development Authority (BARDA) invests in 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. BARDA is one of the leading public sector funders of advanced development of antimicrobial therapeutics and diagnostics worldwide, having invested more than $2.4 billion in antimicrobial products since 2010. This investment has supported the development of over 160 antimicrobial products and led to the U.S. Food and Drug Administration (FDA) approval of four new antibiotics and FDA 510(k) clearance of eight diagnostics.
About Wellcome
Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, infectious disease and climate and health.
About the German Federal Ministry of Education and Research (BMBF)
Education and research are crucial foundations for our future. Thus, the promotion of education, science and research is a policy priority of the German Federal Government. The German Federal Ministry of Education and Research (BMBF) strengthens education at all stages of life and provides support for scientific research and innovation.
About the Global AMR Innovation Fund (GAMRIF)
The Global AMR Innovation Fund (GAMRIF) is a One Health aid fund that supports research and development around the world to reduce the threat of antimicrobial resistance (AMR) in humans, animals and the environment for the benefit of people in low- and middle-income countries (LMICs). GAMRIF core objectives are to develop innovative One Health solutions to tackle AMR; increase availability of context-specific, accessible, and affordable innovations for LMICs; establish international research partnerships with industry, academia, and governments; and collaborate with and leverage additional funding from other global donors.
About the Public Health Agency of Canada
The Public Health Agency of Canada is an agency of the Government of Canada that is responsible for public health, emergency preparedness and response, and infectious and chronic disease control and prevention. Created in 2004 with a mission to promote and protect the health of Canadians through leadership, partnership, innovation and action in public health, the Agency’s activities focus on preventing disease and injuries, responding to public health threats, promoting good physical and mental health, and providing information to support informed decision making. The Agency has a long history of working with domestic and international partners on combatting health threats, including AMR. Most recently, the Agency released the Pan-Canadian Action Plan on AMR, a multijurisdictional effort that emphasizes One Health collaboration to make progress on AMR.
About the Novo Nordisk Foundation
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.
About Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With nearly 37,000 students, it is one of the largest private residential universities in the United States. BU consists of 17 schools and colleges, along with the Faculty of Computing & Data Sciences and 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 leading research universities in the United States and Canada. For further information, please contact Kim Miragliuolo at kmira@bu.edu. www.bu.edu