Combating Antibiotic Resistant Bacteria Accelerator

Scout aims to expand access to STI testing by providing affordable, accurate, and convenient STI testing BOSTON, April 18, 2024 /PRNewswire/ -- Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award up to US$1 million to diagnostics and health tech company Scout to demonstrate proof-of-concept and feasibility ahead of development of a new point-of-care test – STI Scout. The test will detect and differentiate between Neisseria gonorrhoeae (Ng) and Chlamydia trachomatis (Ct). STI Scout is quick and inexpensive, with a turnaround time of 30 minutes and costs anticipated to be less than half of other options. Continue Reading Cam Ball, PhD, Scout CTO and Co-Founder Additionally, STI Scout can use either first void urine or vaginal swabs, and future tests will be able to guide therapy for gonorrhea treatment based on antibiotic susceptibility. STI Scout uses the Scout Hub to run and the Scout Connect mobile app, which provides instructions, tracks results, and eventually will allow patients to connect digitally to a healthcare provider. Scout is leveraging their patented Loop-de-Loop chemistry, a proven isothermal technology that was validated for highly accurate SARS-CoV-2 detection with Scout's system, which has an FDA Emergency Use Authorization for point-of-care settings and an authorization for use in over-the-counter (OTC) settings pending. The CARB-X award will help Scout expand its test menu to offer simple and efficient point-of-care testing at STI clinics and urgent care centers and as a potential future option, an at-home test for STIs. Gonorrhea is the second most reported bacterial STI. Approximately 82 million people were infected globally in 2020. Patients with gonorrhea can face serious health effects, including pelvic inflammatory disease, chronic pelvic pain, and infertility. Since patients do not always exhibit symptoms, reported cases may only capture a fraction of the true burden. Decentralizing testing could greatly benefit patients, as clinics and urgent care centers could have fast, accurate, and affordable tests enabling same-day results which would expedite appropriate treatment. Notably, the low-cost design of the consumables and simple-to-use interface could enable Scout's test to be used globally, expanding access to Ng testing to the lowest levels of the healthcare system in resource-limited settings. With further development, the Scout system tests also could be used at home, which is especially valuable among patient populations that are testing routinely. "There is a need for affordable, accurate, and easy-to-use tests that expand access to testing for and proper treatment of Neisseria gonorrhoeae to urgent care centers, STI clinics, and the like", said Erin Duffy, PhD, R&D Chief of CARB-X. "Given the prevalence of gonorrhea globally, and the growing prevalence of drug-resistant gonorrhea, to diagnose quickly and affordably would allow physicians at all levels of the healthcare system to treat rapidly with the most appropriate therapy. The impact of a test like Scout's could be vast." "Our goal is to improve access to accurate diagnostics for everyone. Scout's approach benefits clinicians and patients by providing timely, accurate results which can lead to earlier diagnosis and treatment of patients. Importantly, Scout also could assist healthcare providers in determining which treatments are appropriate for the patient and can assist combating the spread of antibiotic resistance bacteria" said Cam Ball, PhD, Scout CTO and Co-Founder. An estimated 1.27 million people died due to drug-resistant bacterial infections in 2019, a death toll that exceeded HIV/AIDS (864,000) and malaria (643,000) in that same year. CARB-X is building a pipeline of high-value products to prevent, diagnose and treat bacterial infections, including those that have become resistant to antibiotics. CARB-X emphasizes performance characteristics that will allow the broadest use of these products against infections driving the greatest global morbidity and mortality. When CARB-X was founded in 2016, the early-stage antibiotic pipeline was stalled. Since then, CARB-X has supported 101 R&D projects in 13 countries, and CARB-X product developers have made tremendous progress: 18 projects have advanced into or completed clinical trials; 12 remain active in clinical development, including late-stage clinical trials; and two diagnostic products have reached the market. Additionally, at least nine product developers with active R&D projects already have secured advanced development partnerships which can help support their clinical development after leaving the CARB-X portfolio. In 2022, CARB-X launched new funding rounds to support R&D projects and fill critical gaps in the antibacterial pipeline. These include oral therapeutics to replace the workhorse antibiotics that are failing; vaccines for neonatal sepsis, which kills 2.5 million infants annually; and oral therapeutics, vaccines and rapid diagnostics for gonorrhea. Scout's diagnostic is the second diagnostic and ninth project to receive a CARB-X award as part of the 2022-2023 funding call. Additional projects are under review, and new product developers will be announced this year. Register for the CARB-X newsletter to learn more about upcoming funding calls that will be announced this year. CARB-X funding for this research is supported by federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number 75A50122C00028, and by awards from Wellcome (WT224842), Germany's Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care as part of the Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Public Health Agency of Canada (PHAC), the Bill & Melinda Gates Foundation, and the Novo Nordisk Foundation. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. 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: Marissa Novel, [email protected] Scout Contact: Jared Hsu, [email protected] 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. | X (formerly Twitter) @CARB_X About Scout Scout is a US-based health technology and diagnostics company focused on the development of innovative diagnostic solutions for at-home and point-of-care use. The company's platform technology facilitates the rapid development of molecular diagnostic tests that are both accurate and cost-effective. Scout's integrated system includes the Scout Hub, the Scout Connect mobile application, and single-use Scout Test Kits. Currently, Scout's product pipeline targets respiratory health, sexual health, and women's health, among other areas. Previously known as Uh-Oh Labs, Scout received FDA Emergency Use Authorization for its COVID-19 test in clinical settings, with its over-the-counter version presently under FDA review. The company has garnered support and funding from several prestigious institutions, including the NIH's Rapid Acceleration of Diagnostics (RADx) initiative, the NIH's Point-of-Care Technologies Research Network (POCTRN), the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), and Y Combinator. For additional information, visit scouthealth.com or follow Scout on X (formerly Twitter) and Instagram @tryoutscout 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. The Administration for Strategic Preparedness and Response (ASPR) leads the nation's medical and public health preparedness for, response to and recovery from disaster and other public health emergencies. Within ASPR, the Biomedical Advanced Research and Development Authority (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 and is one of the leading public sector funders of advanced development of antimicrobial therapeutics and diagnostics. As part of HHS, 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. News releases, fact sheets and other NIAID-related materials are available on the NIAID website. 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 Global AMR Innovation Fund (GAMRIF) is a One Health UK aid fund that supports research and development around the world to reduce the threat of antimicrobial resistance (AMR) in humans, animals and the environment for the benefit of people in low- and middle-income countries (LMICs). GAMRIF core objectives are to develop innovative One Health solutions to tackle AMR; increase availability of context-specific, accessible, and affordable innovations for LMICs; establish international research partnerships with industry, academia, and governments; and collaborate with and leverage additional funding from other global donors. About the Public Health Agency of Canada The Public Health Agency of Canada is an agency of the Government of Canada that is responsible for public health, emergency preparedness and response, and infectious and chronic disease control and prevention. Created in 2004 with a mission to promote and protect the health of Canadians through leadership, partnership, innovation and action in public health, the Agency's activities focus on preventing disease and injuries, responding to public health threats, promoting good physical and mental health, and providing information to support informed decision making. The Agency has a long history of working with domestic and international partners on combatting health threats, including AMR. Most recently, the Agency released the Pan-Canadian Action Plan on AMR, a multijurisdictional effort that emphasizes One Health collaboration to make progress on AMR. About the Novo Nordisk Foundation Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people's health and the sustainability of society and the planet. The Foundation's mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society. 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 71 leading research universities in the United States and Canada. For further information, please contact Kim Miragliuolo at [email protected]. SOURCE Scout

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has been awarded a grant from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global non-profit partnership dedicated to supporting the early development of antibacterial products. The grant award is to support initial preclinical activities on the antibiotics program recently acquired from Spexis. The initial funding of up to USD 0.9 million will support the work until candidate nomination in the second half of 2024. Basilea could receive additional funding from CARB-X, to continue preclinical and early clinical development of the antibiotics program, if the project achieves certain milestones. Dr. Laurenz Kellenberger, Chief Scientific Officer of Basilea, said: "We are delighted by CARB-X’s commitment to fund the development of these promising, first-in-class antibiotics, which have the potential to address an unmet medical need in the hospital-based treatment of severe infections, caused by Gram-negative bacteria. We look forward to working with CARB-X to bring our new antibiotics to patients." The program comprises antibiotics targeting LptA, which is part of the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria. The molecules belong to one of the very few novel classes of antibiotics in development. Potent and rapid bactericidal activity has been shown in vitro and in vivo against Gram-negative bacteria of the Enterobacteriaceae family, such as E. coli and K. pneumoniae, including strains resistant to beta-lactams and colistin, an antibiotic regarded as last-resort therapy.1 Enterobacteriaceae have been highlighted by the World Health Organization as priority pathogens, against which new antibiotics are urgently needed.2 CARB-X’s funding for this project is provided in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; Antibacterials branch; under agreement number 75A50122C00028; and by awards from Wellcome (WT224842) and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. 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. | X (formerly Twitter) @CARB_X About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor Relations Basilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b 4123 Allschwil Switzerland Phone +41 61 606 1102 E-mail media_relations@basilea.com investor_relations@basilea.com This press release can be downloaded from . References M. Schuster, E. Brabet, K. K. Oi et al. Peptidomimetic antibiotics disrupt the lipopolysaccharide transport bridge of drug-resistant Enterobacteriaceae. Science Advances 2023 (9), eadg3683 (Accessed: April 08, 2024) Press release (PDF)

COPENHAGEN, Denmark, Jan. 9, 2024 /PRNewswire/ -- The Novo Nordisk Foundation is committing up to USD 25 million to support the early-stage development of innovative tools to prevent, diagnose and treat the most dangerous drug-resistant bacterial infections. The three-year grant will go to the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), the leading global non-profit public-private partnership in this space. Antimicrobials, including antibiotics, are the world's primary defence against infections. But when the bacteria, viruses, fungi or parasites that cause those infections mutate and become resistant to existing treatments, simple infections can lead to severe illness or death. Antimicrobial resistance (AMR) threatens to unravel societies and the global economic system by increasing the risks of performing routine medical procedures such as caesarean sections, hip replacements and chemotherapy, impairing our food chain, and diminishing productivity. The most comprehensive assessment of the burden of AMR to date found that drug-resistant bacterial infections alone caused an estimated 3,500 deaths every day in 2019, a number on the rise and already higher than both HIV/AIDS and malaria. According to the World Bank, in a high AMR-impact scenario, the world would lose 3.8 percent of its annual GDP by 2050, with an annual shortfall of $3.4 trillion by 2030. A key part of the solution is the development of new vaccines, diagnostic tools, antibiotics, and other innovative interventions that can help prevent these infections, diagnose them quickly and accurately, and treat them effectively. Yet, most major pharmaceutical companies have exited the market and those left in the early development space tend to be academic spinouts and small companies in need of grants and guidance. CARB-X, a global non-profit partnership funded by four G7 governments and three of the world's biggest foundations, is a leading provider of support to these product developers. The partnership, therefore, plays a crucial role in moving promising ideas for cutting-edge antibacterial products from basic research to clinical development and through Phase 1 clinical trials. Since 2016, CARB-X has funded 93 projects in 12 countries. Nineteen projects have advanced into or completed clinical trials; 12 remain active in clinical development, including late-stage clinical trials; and two diagnostic products have reached the market. "Like CARB-X, the Novo Nordisk Foundation is committed to driving innovation in the fight against drug-resistant infections," says Peter Lawætz Andersen, Senior Vice President, Infectious Diseases at the Foundation. "By partnering, we can help ensure that the best research gets translated into effective, scalable and affordable medical interventions that can help end this growing pandemic." "CARB-X is grateful for this generous contribution from the Novo Nordisk Foundation, a key ally in CARB-X's mission," says Kevin Outterson, Executive Director of CARB-X and Austin B. Fletcher Professor of Law at Boston University. "This new funding is a testament to our shared commitment to supporting the pioneering efforts of antibacterial product developers, mainly university spinoffs and small biotech companies, in advancing much-needed innovation to prevent, diagnose and treat the most dangerous drug-resistant bacterial infections." Battling a broken market Despite the importance of antibiotics in modern medicine, only two new classes (types) have reached the market since 1962 and there are very few in clinical development. According to the World Health Organization, "the clinical pipeline and the recently approved antibacterial agents are insufficient to tackle the challenge of increasing emergence and the spread of AMR." Private investments in innovative antibiotics are poor partly because doctors use them only when older and cheaper drugs fail. This is important to prolong their effectiveness, but it also limits their sales. This broken market has created a huge funding gap in antibacterial product development. A report for the European Commission has recently estimated that an additional global investment of USD 250 to 400 million from public and philanthropic sources is needed every year for the R&D of products that counter drug resistance, and that this investment should focus in the early phase of development, which is where CARB-X operates. Novo Holdings – the Foundation's wholly owned subsidiary – established the REPAIR (Replenishing and Enabling the Pipeline for Anti-Infective Resistance) Impact Fund in 2018 to address this early-stage funding gap. While continuing to support the existing portfolio, REPAIR has paused new investments due to the challenging market conditions, with the Foundation now supporting the critical early-stage pipeline via the philanthropic grant to CARB-X. Developing cutting-edge products The grant is also part of a broader commitment from the Foundation and Novo Holdings to fight drug resistance through the development of innovative products. The organisations are engaged in a range of activities from early development to advocating for payment models that can help rejuvenate the market for antimicrobials. The Foundation is also funding a major new initiative – the Novo Nordisk Foundation Initiative for Vaccines and Immunity – that will reduce the use of antibiotics and thus the spread of AMR by developing vaccines against respiratory infections. With this grant, the Novo Nordisk Foundation joins major governments and foundations in supporting the work of CARB-X. Efforts are focused on the most dangerous bacteria which have been prioritized by the World Health Organization and the United States Centers for Disease Control and Prevention (CDC), the syndromes with the greatest morbidity and mortality across the world, and the performance characteristics that clinicians and patients need the most. Beyond non-dilutive funding, CARB-X provides grantees with scientific, clinical, regulatory, and business development guidance and access to tools that aim to accelerate product development. About the Novo Nordisk Foundation Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people's health and the sustainability of society and the planet. The Foundation's mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society. 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. | X (formerly Twitter) @CARB_X CARB-X is supported by federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number 75A50122C00028, and by awards from Wellcome (WT224842) and 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), the Bill & Melinda Gates Foundation, and the Novo Nordisk Foundation. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. 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. 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. The Administration for Strategic Preparedness and Response (ASPR) leads the nation's medical and public health preparedness for, response to and recovery from disasters and other public health emergencies. Within ASPR, the Biomedical Advanced Research and Development Authority (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 and is one of the leading public sector funders of advanced development of antimicrobial therapeutics and diagnostics. As part of HHS, the National Institutes of Health (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. Within NIH, the National Institute of Allergy and Infectious Diseases conducts and supports research — 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. News releases, fact sheets and other NIAID-related materials are available on the NIAID website. 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 Global AMR Innovation Fund (GAMRIF) is a One Health UK aid fund that supports research and development around the world to reduce the threat of antimicrobial resistance (AMR) in humans, animals and the environment for the benefit of people in low- and middle-income countries (LMICs). GAMRIF core objectives are to develop innovative One Health solutions to tackle AMR; increase availability of context-specific, accessible, and affordable innovations for LMICs; establish international research partnerships with industry, academia, and governments; and collaborate with and leverage additional funding from other global donors. 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 [email protected]. SOURCE Novo Nordisk Foundation