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CARB-X 2020-21 Annual Report: CARB-X surpasses all goals in first five years in combatting antibiotic resistant-bacteria

CARB-X 2020-21 Annual Report: CARB-X surpasses all goals in first five years in combatting antibiotic resistant-bacteria

CARB-X continues to prepare the world against antibiotic-resistant bacteria

(BOSTON: October 12, 2021) – CARB-X closed its fifth fiscal year on July 31, 2021 with US$361 million awarded to 92 projects funding since inception. In its latest fiscal year, CARB-X invested in 25 new projects across all three pillars – preventatives, diagnostics, and therapeutics. This year saw two more successful graduations from the portfolio, four more First-in Human programs launch, and several strategic augmentations of the portfolio including in the areas of: gonorrhea, bacteriophage, vaccines, peptides and polymyxins, and anti-virulence factors.

“In our fifth year, we augmented our portfolio along many themes, including non-traditional therapeutics, where we can simultaneously drive individual projects towards meaningful products and answer key questions that unlock value more generally for these new modalities,” said Erin Duffy, PhD, Chief of Research and Development at CARB-X, a non-profit global partnership supported by Boston University.

These achievements and more are highlighted in CARB-X’s 2020-2021 Annual Report published today. CARB-X continued to fulfill its mission to accelerate a diverse portfolio of innovative antibacterial products towards clinical development and regulatory approval with funding, expert support and cross-project initiatives.

Kicked-off towards the end of the prior fiscal year, CARB-X advanced ecosystem understanding of AMR product development through new cross-project initiatives in year five. These include early evaluation of pre-existing resistance risk for therapeutics or antigenic variability for preventatives, consistent assessment of key safety risks and improved animal models of infection.

In year five, CARB-X introduced product developers from two new countries into the portfolio: Italy and Denmark, raising the collective number of countries to 12. Together with partners, CARB-X also launched the world’s first practical guidance on strategies and activities to support Stewardship and Access for companies bringing new antibacterial products to market.

At year end, CARB-X had 60 active projects in portfolio, including 19 antibiotics with novel classes, 16 non-traditional therapeutics, 12 vaccines and preventatives, 12 rapid diagnostics, and one unique enhancement to an existing antibiotic class.

Over the course of five years, over 1,160 applications were submitted and reviewed from all eight funding rounds. These applications represented innovation from 39 countries on five continents. Furthermore, of the 92 projects that entered the CARB-X portfolio since 2016, 54 invention disclosures were filed – 36 for therapeutics, 6 for preventatives and 12 for diagnostics. This is yet another indicator of the sheer breadth of innovation accelerating at CARB-X. Since inception, CARB-X’s portfolio has supported nine projects through Investigational New Drug/IND-equivalent approvals, ten projects in Phase 1 development, of which eight included First-in-Human activities. In total, nine projects have graduated from the portfolio.

“We’ve accomplished so much in just five years and the work continues,” said Kevin Outterson, Executive Director of CARB-X. “As we forge ahead to rapidly and accurately diagnose patients with antibiotic-resistant infections, strengthen our antibiotic arsenal, and prevent infection altogether, it is paramount that we continue to engage with global partnerships to advance the science, and increase access, and promote good stewardship practices.”

This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from Wellcome Trust and Germany’s Federal Ministry of Education and Research (BMBF), UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), and the Bill & Melinda Gates Foundation. The contents are solely the responsibility of the author and do not necessarily represent the official views of any CARB-X funders.

CARB-X contact: Genevieve Holmes, carbxpr@bu.edu

About CARB-X

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 U.S. Department of Health and Human Services, the Wellcome Trust, a global charity based in the U.K. working to improve health globally, Germany’s Federal Ministry of Education and Research (BMBF), the U.K. 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 U.S. 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 and early stage development products against antibiotic resistant infections. CARB-X is headquartered at Boston University School of Law. For more information on CARB-X’s first five years, visit this fact sheet. Follow us at carb-x.org and on 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. 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 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 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, U.K.)

About the German Federal Ministry of Education and Research (BMBF)

Education and research are the foundations for our future. The promotion of education, science and research by the 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 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 c.£50m 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 the Bill & Melinda Gates Foundation

Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people’s health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Mark Suzman and Co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.

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 jeremy22@bu.edu. www.bu.edu.