Seeking preventatives, diagnostics and therapeutics that address neonatal sepsis, gonorrhea and the most threatening antimicrobial-resistant bacterial infections

(BOSTON: October 3, 2022) – CARB-X, part of Boston University, announced today an omnibus solicitation, with three distinct product themes:

• ORAL THERAPEUTICS

  The scope is restricted to oral products with several syndromes and causative agents possible, including respiratory tract infections, urinary tract infections and syndromes caused primarily by Gram-positive pathogens. In all cases, activity against multidrug-resistant organisms on the WHO and CDC bacterial threat lists is essential.

• VACCINES FOR NEONATAL SEPSIS

  The scope is restricted to vaccines focused on the prevention of neonatal sepsis, targeting several possible bacterial species, including Klebsiella pneumoniae, Escherichia coli (ETEC or urinary), Acinetobacter baumannii and Staphylococcus aureus. While a maternal vaccine is sought, it is expected that a commercial indication could be proposed.

• GONORRHEA PRODUCTS

  The scope is open to products that address Neisseria gonorrhoeae, including, for example, oral therapeutics, low-cost vaccines and rapid, point-of-care diagnostics. Products must address both drug-sensitive and drug-resistant scenarios.

Target product profiles and minimal acceptable criteria will be defined.

• October 31, 2022 at 23:59 ET
• January 30, 2023 at 23:59 ET
• May 1, 2023 at 23:59 ET

“For our 2022-23 funding calls, we seek to fill major gaps in the global pipeline,” said Erin Duffy, Ph.D., R&D Chief of CARB-X. “For example, the 2021 publication of the BARNARDS study estimates that 2.5 million neonates or infants in the first month of life die annually of sepsis, with the greatest burden in low- and middle-income countries where treatment strategies are empirical and difficult to monitor. A maternal vaccine targeting the pathogens accounting for the highest number of deaths would have a major impact on preventing neonatal sepsis. The WHO clinical and preclinical pipelines are thin where most of these pathogens are concerned.”

To apply, applicants must be a legal entity. When the sub-award contract is executed, applicants must provide at least 30% of the product development cost through the contract performance period. Applicants must also own or have secured the rights to intellectual property and have a reasonable expectation of freedom to operate. Academic centers and non-commercial developers are encouraged to apply, if they can demonstrate similar capabilities expected of a drug development industry partner. Applicants must adhere to the highest ethical research standards, and they will be reviewed by experts. Final funding decisions are made by CARB-X. For complete details on the scope of the funding rounds and how to apply, visit CARB-X.org.

“Our new awards from BARDA and Wellcome have allowed us to plan for and target the most critical global health needs,” said Kevin Outterson, Executive Director of CARB-X and Professor of Law at Boston University. “These new calls are consistent with CARB-X’s focus on accelerating a diverse portfolio of innovative antibacterial products towards clinical development and regulatory approval with the support of funding, expertise and Portfolio Acceleration Tools.”

In 2019, an estimated 1.27 million people died due to antimicrobial-resistant bacterial infections. Since its founding in 2016, CARB-X has provided US$396M to 92 preclinical candidates to address bacterial infections. These projects include vaccines, rapid diagnostics, antibiotics, and non-traditional therapeutics and preventatives. CARB-X provides funding to projects in the early stages of development, and offers business, clinical and regulatory expertise from its in-house R&D team and worldwide network of subject matter experts. To inform its new funding calls, CARB-X reviewed the global product pipeline, the CARB-X portfolio, and research on unmet medical needs (most notably, The Lancet’s 2022 publication, Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis).

A pre-recorded video with application details will be available on October 11 at CARB-X.org. Two public webinars will be held on October 19, 2022 at 7PM ET and October 20, 2022 at 8AM ET to discuss the scope of the funding rounds, application process, and to answer questions. Register for the webinars at CARB-X.org.

CARB-X is funded in part with federal funds from the 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), 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 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.