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The CARBX Portfolio of Nontraditional Antibacterial Products

Erin M. Duffy,* Ed T. Buurman, Su L. Chiang, Nadia R. Cohen, Maria Uria-Nickelsen, and Richard A. Alm

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Cite This: ACS Infect. Dis. 2021, 7, 2043-2049

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ABSTRACT: The growing prevalence of antibiotic-resistant bacterial pathogens and the lack of new medicines to treat the infections they cause remain a significant global threat. In recent years, this ongoing unmet need has encouraged more research groups to focus on the discovery and development of nontraditional antibacterial agents, ranging from anti-virulence strategies to bacteriophage and ways to modulate the microbiome. The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global nonprofit public-private partnership dedicated to accelerating antibacterial-related research. Importantly, the CARB-X portfolio supports a wide variety of novel and innovative nontraditional programs to help the global antibacterial research ecosystem understand the potential that these modalities can play in the management or prevention of serious infections. We describe here the breadth of the CARB-X pipeline of novel nontraditional products.

KEYWORDS: antibacterial, nontraditional, CARB-X, research and development, therapeutics, preventatives

A s the world struggles with the constant rise in the level of antibacterial resistance, a limited pipeline of new agents remain that can be used to treat or prevent these life-threatening infections.1,2 Of further concern is the fact that many of the products in clinical development represent incremental improvement of existing drug classes. In 2016, in response to this crisis, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X; carb-) was formed to provide financial and scientific support to groups developing novel therapeutic, preventative, and diagnostic products to address the largely drug-resistant bacterial pathogens listed on the WHO Global Priority Pathogens List and the CDC Threat Assessments list.3,4 CARB-X is headquartered at Boston University and is funded by three governments and two philanthropic organizations: (1) 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; (2) the Wellcome Trust, a global charity based in the UK working to improve health globally; (3) Germany's Federal Ministry of Education and Research (BMBF); (4) the UK Department of Health and Social Care's Global Antimicrobial Resistance Innovation Fund (GAMRIF); (5) the Bill & Melinda Gates Foundation. In addition, CARB-X receives in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).5

In 2019, CARB-X held a specific funding call that was aimed at nontraditional modalities and innovative ways to address the growing threat of antibiotic resistance.6,7 The past decade or so of scientific innovation and understanding has seen the maturation of technologies in multiple areas of drug discovery, including CRISPR, immunotherapy and harnessing of the innate immune system, and the link between the microbiome and a range of diseases. These approaches are also being explored in the field of antibacterial drug discovery, and CARB-X supports these novel approaches through the development stages of Hitto-Lead to First-in-Human testing (Phase 1) with the mandate to progress forward a diverse group of medicines with the potential to transform patient care. This Perspective summarizes the wide range of nontraditional products that are currently supported by CARB-X funding.

NONTRADITIONAL ANTIBACTERIAL AGENTS SUPPORTED BY CARB-X

Nontraditional antibacterial agents cover a range of products with different modalities, including anti-virulence approaches,

Special Issue: Antibiotic Alternatives

Received: June 18, 2021 Published: August 4, 2021

? 2021 American Chemical Society

2043

ACS Infect. Dis. 2021, 7, 2043-2049

ACS Infectious Diseases

pubs.journal/aidcbc

Perspective

bacteriophage, and live biotherapeutic products.8,9 Indeed, approximately 34% of the active CARB-X portfolio is composed of nontraditional products (Table 1) for both the treatment and

Table 1. Categorization of the CARB-X Pipeline

product class

traditional direct-acting agents nontraditional agents peptides vaccines diagnostics (identification and/or

susceptibility) total programs

number 15 22 7 8 12

64

percentage of portfolio 23 34 11 13 19

100

prevention of serious bacterial infections. Although it is difficult to classify the 22 nontraditional products without knowing precisely how they would ultimately bring the most clinical benefit to patients, broadly speaking, we envisage our nontraditional portfolio as containing 8 therapeutic products that could be used as stand-alone therapy, 8 "adjunctive" products that would likely require the coadministration of another directacting antibacterial agent, and 6 preventative products that would be used to reduce the likelihood of developing a serious infection. In addition, the CARB-X portfolio contains seven programs that can be classified as direct-acting peptides, all of which are ................
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