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U.S. government and Wellcome commit up to an additional US$370 million to CARB-X

U.S. government and Wellcome commit up to an additional US$370 million to CARB-X

CARB-X continues its acceleration of innovative therapeutics, preventatives and diagnostics against antibiotic-resistant bacteria

(BOSTON: May 19, 2022) – After celebrating its five-year anniversary in 2021, CARB-X (part of Boston University) announces renewed support from the U.S. Department of Health and Human Services (HHS) and Wellcome, a global charitable foundation. The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within HHS, will provide US$20 million initially and up to US$300 million over 10 years to support the existing portfolio and launch new funding rounds. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, will provide support in the form of in-kind services through access to a suite of preclinical services for product development. Wellcome will provide up to US$70 million over three years as part of its continued commitment to address the escalating threat of drug-resistant infections. Initial funding of $355 million from both BARDA and Wellcome originally launched CARB-X in 2016, and the new funding announced today builds on the success of this international non-profit partnership.

“We are grateful for the leadership and commitment demonstrated by BARDA and Wellcome in addressing the global challenge of antimicrobial resistant bacteria,” said Kevin Outterson, Executive Director of CARB-X and Professor of Law at Boston University. “We now know that antimicrobial resistance (AMR) kills more people each year than HIV or malaria, and a similar number to TB. AMR is a top-tier global killer. With today’s funding announcements, CARB-X will continue to invest to support early-stage research and development (R&D) for new antibacterial therapies, preventatives, and diagnostics.”

In addition to BARDA, NIAID and Wellcome, other CARB-X funders and partners include the U.K. and German governments (the Global AMR Innovation Fund and the Federal Ministry of Education and Research), and the Bill & Melinda Gates Foundation. Their original agreements end in 2022 and 2023 and are not yet up for renewal.

“Antibiotic-resistant infections not only pose a growing public health crisis but also complicate the response to public health emergencies. We see a wealth of valuable basic AMR research and early discovery stemming from NIAID and other critical organizations around the globe. Alongside our CARB-X global partners, we are helping transform this research into preclinical and clinical candidates that, with potential support from BARDA and other late-stage funders, can be further developed into approved products that can help prevent and treat bacterial infections, and ultimately, save lives,” said Gary Disbrow, PhD, Director of BARDA.

Since its inception, CARB-X has received over US$500 million and invested US$361 million of this non-dilutive funding to support the advancement of 92 innovative projects in 12 countries.

Today, the program is made up of a scientifically diverse portfolio that is focused on detecting and eradicating bacterial infections where resistance is threatening the foundation of modern medicine. The hallmark of the portfolio is a spectrum of innovation that will deliver meaningful products that diagnose, prevent and treat infections caused by antibiotic-resistant bacteria.

All active treatment programs feature a novel class of antibiotics, binding a novel bacterial target, or acting on a new pathway, hence offering the ability to prevent cross-resistance with current anti-bacterial mechanisms.

The program already has accelerated products toward the clinic, with eleven candidates for treatment or prevention having progressed into first-in-human clinical trials and with more expected to begin trials later this year. Four diagnostics have progressed into the validation and verification stage, which primes them for pivotal clinical trials. Two companies formerly supported by CARB-X are now supported by BARDA for advanced R&D to bring their candidates closer to approval.

Erin Duffy, Chief of R&D at CARB-X, has prioritized strengthening and diversifying the pipeline by making strategic portfolio decisions. “We are exploring key questions that unblock the path for new products to emerge. An example is bacteriophage, where we are asking whether treatment or prevention is the best placement for this modality, what syndromes and pathogens are the best targets, what trial designs will best highlight medical value and what performance characteristics are essential. In diagnostics, we have sharpened our focus by asking what products would be most meaningful to our treatment and prevention products to open a path to clinical trial feasibility and to influence market uptake after approval.”

There have been no novel classes of antibiotics approved in the last 20 years (Blaskovich, M.A.T., 2019 The diminished antimicrobial pipeline, Micro. Aust.) The last one, linezolid, was approved in 2000 but its class, oxazolidinone, was discovered in 1978. An additional challenge specific to this area is that once approved, the products needed to treat antibiotic-resistant infections should be used only when necessary, otherwise bacteria develop further resistance. Because current commercial models do not reward antibiotic stewardship, developers often struggle to recoup R&D costs or see a return on investment. This has led many companies to withdraw from the antibacterial space, creating diminished investment in innovation and weak pipelines.

The non-dilutive funding and wrap-around technical, regulatory, and business support that CARB-X provides to companies in early-stage development help to overcome these challenges and ensure there is a pipeline of candidates poised for advanced R&D by late-stage development funders.

“Early-stage research and development for antibiotics was stalled in 2016. Since our first investment in CARB-X, the initiative has successfully fostered innovation in this essential stage of development for antibiotics, vaccines, and diagnostics. We are proud to have been part of CARB-X’s journey to ensure promising products can make it to patients who need them. This additional investment will help CARB-X continue to revitalise the world’s antibacterial pipeline and other interventions to control antimicrobial resistance,” said Dr. Timothy Jinks, Head, Infectious Disease Interventions, Wellcome.

Antibiotic resistance is a rapidly growing and deadly threat to the health of humanity and our global economy. Global Research on AntiMicrobial resistance (GRAM) Project released a report in The Lancet on 20 January 2022 estimating 1.27 million deaths occurred in 2019 due to antibiotic-resistant infections.

“CARB-X’s mission and global public-private partnership is filling a critical gap to help stem the AMR crisis,” said Dr. Robert A. Brown, President of Boston University. “We are grateful for the support of BARDA and Wellcome as researchers accelerate the discovery of new antibiotic classes around the world.”

A public webinar will be held on June 9, 2022 at 09:00am EDT with representatives from CARB-X, BARDA, Wellcome and NIAID to discuss the global health issues of AMR, and how CARB-X and its partners are working together to address them.

Register in advance to attend the public webinar.

The contents of this news release are solely the responsibility of the author and do not necessarily represent the official views of all CARB-X funders.

CARB-X Contact: Robin Berghaus, 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, Wellcome, a global charity working to improve health worldwide, 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 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, view a fact sheet on CARB-X’s first five years and 2020-2021 annual report. Visit carb-x.org and follow CARB-X 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 against 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 
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 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