CARB-X accelerates new products to address the global threat of antimicrobial resistance

(BOSTON: April 27, 2023) – CARB-X published its 2021-2022 annual report today. The report highlights achievements, including CARB-X projects in clinical development, new products on the market, renewed funding commitments, open funding rounds, and Portfolio Acceleration Tools, a series of research projects led by CARB-X to support multiple product developers.

CARB-X’s dedication to accelerating new preventatives, rapid diagnostics, and therapeutics, remains critical to help address the global health threat of antimicrobial resistance (AMR). In January 2022, a thorough analysis estimated 1.27 million people died in 2019 due to AMR bacterial infections, killing more people than HIV/AIDS and malaria in that same year. Yet AMR innovation is lagging. That is why CARB-X continues to forge ahead, and global leaders agree that its work is essential.

“CARB-X is playing a critical role in bringing together partners up and down the research pipeline, helping to ensure that more life-saving, antibacterial products succeed on the road from discovery science to clinics and patients,” said Timothy Jinks, Ph.D., Head of Infectious Disease Interventions, Wellcome.

In May 2022, G7 Health Ministers declared they “value and support initiatives like CARB-X” as key solutions for “urgently-needed antimicrobial drugs, vaccines alternative therapeutics and diagnostics.” In that same month, BARDA and Wellcome announced renewed funding to CARB-X, providing up to US$370 million over the next decade, while NIAID announced it would continue to provide in-kind support.

“CARB-X is a crucial accelerator, driving innovative AMR programs toward advanced development and regulatory approval,” said BARDA Director Gary Disbrow, Ph.D. “With our recently renewed commitment to this global partnership, we will continue to work together over the next decade to develop products that help save lives and address national health security concerns.”

Over the past year, CARB-X product developers made tremendous progress advancing their projects through the development pipeline:

• 8 prevention and therapeutic candidates began or progressed through Phase 1 and Phase 1b clinical trials. These represent a range of modalities, including broad-spectrum antibiotics by Bugworks and Peptilogics, biofilm-targeting monoclonal antibodies by Trellis Bioscience and Clarametyx Biosciences, a CRISPR-engineered bacteriophage by SNIPR Biome, a live biotherapeutic candidate by Seres Therapeutics, and both a vaccine and a small-molecule anti-virulence inhibitor by GlaxoSmithKline;
• Vedanta Biosciences entered Phase 3 clinical trials with a live biotherapeutic candidate;
• 2 diagnostics by HelixBind and Proteus entered the verification and validation stage; and
• 2 diagnostics by T2 Biosystems and Specific Diagnostics (acquired by bioMérieux in 2022) are now on the market.

“While CARB-X had a remarkable year, it is paramount that we continue collaborating with global partners to advance science, increase access to life-saving products, and promote good stewardship practices to address the global threat of antimicrobial resistance,” said Kevin Outterson, Executive Director of CARB-X and Austin B. Fletcher Professor of Law at Boston University.

In October 2022, CARB-X launched three new funding round cycles to support projects that address major gaps in the global pipeline. Applications can be submitted on CARB-X.org until May 1, 2023. The new funding rounds are focused on three themes: oral therapeutics, vaccines for neonatal sepsis, and gonorrhea products. CARB-X partners described the strategy for adopting these themes:

• Oral therapeutics enable patients to be treated at home which help to lower healthcare costs, reduce infection risks, and increase access to care. “The growing burden of antimicrobial resistance increases the urgency for the development of novel antibiotics, especially patient-friendly and cost-effective oral therapeutics. In this regard, CARB-X makes an extraordinary contribution and Germany is proud to support this international non-profit initiative,” said Professor Veronika von Messling, Ph.D., Head of Department, Life Sciences – Research for Health, Germany’s Federal Ministry of Education and Research.
• The BARNARDS study (2021) estimates that 2.5 million neonates or infants die annually of sepsis, with the greatest impact on low- and middle-income countries. The pipeline of products that target common bacteria that cause neonatal sepsis (such as Klebsiella pneumoniae, Escherichia coli, Acinetobacter baumannii and Staphylococcus aureus) is thin. “Premature infants in poor countries who survive long enough to reach hospital then need to endure exposure to multi-resistant bacteria in settings with limited infection control. Vaccines against multi-resistant bacteria such as Klebsiella may be life-saving,” said Dr. Keith Klugman, MD, Ph.D., Director, Pneumonia and Pandemic Preparedness, Bill & Melinda Gates Foundation.
• Only one antibiotic, ceftriaxone, remains effective against resistant strains of Neisseria gonorrhoeae, which is why CARB-X seeks new oral therapeutics, low-cost vaccines and point-of-care diagnostics that address both drug-sensitive and drug-resistant scenarios. “As England’s Chief Medical Officer, I raised the alarm of gonorrhoea becoming an untreatable disease,” said Professor Dame Sally Davies, GCB DBE FRS FMedSci. “As UK Special Envoy for AMR, I am thrilled that the UK is partnering with CARB-X to deliver crucial innovations towards combatting drug-resistant gonorrhoea. This will protect everyone, including the world’s most vulnerable.”

Since CARB-X is in a unique position to support a broad portfolio of antibacterial products, it sees common challenges facing many product developers. “We responded by developing a series of research projects, called Portfolio Acceleration Tools (PATs). The goal of PATs is to save time, energy and money across the entire ecosystem, and accelerate products more quickly to patients,” said Erin Duffy, Ph.D., Chief of Research and Development at CARB-X. In the annual report, CARB-X’s Chief Scientific Officer, Richard Alm, Ph.D., explained the genesis and evolution of PATs, including how a single project benefited product developers in every pillar–therapeutics, preventatives and diagnostics.

CARB-X is funded in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under Agreement number: 75A50122C00028. CARB-X is also funded by awards from Wellcome (WT224842), Germany’s Federal Ministry of Education and Research (BMBF), the UK Global Antimicrobial Resistance Innovation Fund (GAMRIF) funded by the UK Government Department of Health and Social Care (DHSC), and the Bill & Melinda Gates Foundation. 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: Robin Berghaus, carbxpr@bu.edu

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/ | Twitter @CARB_X

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. ASPR leads HHS in preparing the nation to respond to and recovery from the adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. Within ASPR, 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. NIH is the primary U.S. 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
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 Department for Health and Social Care (DHSC) is the U.K. Government department which is responsible for helping people to live more independent, healthier lives for longer. 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 is a U.K. 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 nearly 37,000 students, it is the third-largest independent university in the United States. BU consists of 17 schools and colleges and the interdisciplinary Faculty of Computing & Data Sciences, 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 65 leading research universities in the United States and Canada. For further information, please contact Kim Miragliuolo at kmira@bu.edu. www.bu.edu