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Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Scientists at the Icahn School of Medicine at Mount Sinai and research partners have developed an innovative antibody platform to tackle viruses like SARS-CoV-2 (the virus that causes COVID-19) that can rapidly evolve and render vaccines and treatments ineffective. The platform uses engineered nanobodies to simultaneously target multiple stable regions of the virus that are less likely to mutate, making it harder for resistance to develop. While most therapeutic antibodies target only a single viral site and can lose effectiveness within a year as viruses evolve, this platform has the potential to offer a more durable, resilient defense against these tricky viruses. It could also be potentially adapted to target other pathogens. In lab tests and experiments in mice, the platform was able to effectively target a range of variants of the SARS-CoV-2 virus and even the closely related SARS-CoV virus. A new research project led by researchers at the Barcelona Institute for Global Health and Columbia University aims to develop a lateral flow test for diagnosing malaria at the point of care that would also enable health care workers to determine the severity of the disease and decide whether a course of treatment is necessary. While some patients with uncomplicated malaria can be treated at home, malaria can also rapidly progress and require more complicated treatment in a health care setting. Lateral flow tests for malaria diagnosis exist, but parasite counting using microscopy is needed to determine severity and that cannot be done at the point of care. The researchers, who hope to have a validated prototype by the fall of 2026, are looking to develop a portable, paper-based assay that uses a smartphone and can deliver results within minutes.   Last Monday, Roche announced that its mpox assay, Cobas MPXV, has been listed under the World Health Organization’s (WHO’s) Emergency Use Listing procedure, a designation that aims to accelerate the availability of and access to the test during the current global mpox emergency. The automated real-time PCR-based test detects DNA from the virus that causes mpox using a dual-target approach and previously received Emergency Use Authorization from the US Food and Drug Administration in 2022. Earlier this month, Abbot’s mpox test was also listed on the Emergency Use Listing procedure following a call by WHO for manufacturers to submit expressions of interest back in August.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last week, scientists in Rwanda and partners from the World Health Organization launched the world’s first clinical trial testing a treatment for the deadly Marburg virus amid the ongoing outbreak in the country. There are currently no approved treatments or vaccines against Marburg virus, although a clinical trial of Sabin Vaccine Institute’s investigational vaccine is currently underway in Rwanda. The new trial will investigate the safety and efficacy of remdesivir and the monoclonal antibody MBP091, developed by Mapp Biopharmaceutical with support from the Biomedical Advanced Research and Development Authority.  At the recent G7 Joint Finance and Health Ministers’ Meeting, the Italian government announced a $21 million commitment over the next three years to the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to accelerate the development of innovative products to prevent, diagnose, and treat drug-resistant bacterial infections. AMR is a growing public health crisis, particularly in low- and middle-income countries, and there is an urgent need for international collaboration and investment to revitalize an inadequate clinical pipeline and ensure new antimicrobials, antimicrobial alternatives, and diagnostics are available for patients worldwide.Valneva and LimmaTech announced last week that their Shigella4V (S4V) vaccine has been awarded Fast Track designation by the US Food and Drug Administration. There are no approved vaccines for the Shigella bacteria, which causes shigellosis, the second leading cause of fatal diarrheal disease globally, particularly among children in low- and middle-income countries. S4V is the world’s most clinically advanced tetravalent bioconjugate vaccine for shigellosis. This designation will enable accelerated clinical development and review of the vaccine, which will be investigated in two Phase 2 trials that are expected to begin before the end of 2024.

October 16, 2024 The Honorable Tammy Baldwin Chair Subcommittee on Labor, Health and Human Services, Education, and Related Agencies U.S. Senate Committee on Appropriations Washington, DC 20510 The Honorable Robert Aderholt Chair Subcommittee on Labor, Health and Human Services, Education, and Related Agencies U.S. House Committee on Appropriations Washington, DC 20515 The Honorable Shelley Capito Ranking Member Subcommittee on Labor, Health and Human Services, Education, and Related Agencies U.S. Senate Committee on Appropriations Washington, DC 20510 The Honorable Rosa DeLauro Ranking Member Subcommittee on Labor, Health and Human Services, Education, and Related Agencies U.S. House Committee on Appropriations Washington, DC 20515 Dear Chairs Baldwin and Aderholt and Ranking Members Capito and DeLauro: As you work toward finalizing Fiscal Year 2025 spending, we, the undersigned, urge you to adopt the Senate’s proposal for funding the National Institute of Allergy and Infectious Diseases (NIAID). This funding is critical to ensuring that the nation can respond to public health challenges of today and disease threats of tomorrow. NIAID plays an essential role in addressing long-standing domestic and global health challenges like influenza, asthma, cancer, HIV/AIDS, Sepsis, valley fever, deadly allergic reactions, long COVID, autoimmune diseases, tuberculosis, malaria, neglected diseases, and so much more. With a unique mandate to better understand, treat, and prevent infectious, immunologic, and allergic diseases, NIAID is forging paths to discovery to improve health and save lives. NIAID’s cutting-edge research and network of scientists are eliminating some of the world’s most serious health threats, as well as addressing risks to national security and public health, including antimicrobial resistance (AMR). Because of this work, NIAID is the world’s leader in the global health research and development ecosystem. NIH and NIAID contributed to four-fifths of all U.S. government-supported global health technologies currently in the final stages of the R&D pipeline before they can reach the market and save lives. Thanks to longterm and sustained support from Congress for NIAID over the years, the U.S. has made groundbreaking progress in the fight against diseases at home and abroad. These achievements include but are not limited to: NIAID-funded research spurred the development of the first vaccine for respiratory syncytial virus (RSV). The vaccine will help to prevent an estimated 160,000 hospitalizations and 10,000 deaths of older adults in the United States and is projected to save up to $4 billion in healthcare costs. Decades of NIAID investment helped facilitate public-private partnerships that led to the transformative development of Teplizumab, the first FDA-approved drug for delaying Type 1 diabetes (T1D) onset. The drug can help delay the onset of T1D by two years following a single treatment, which could benefit nearly 200,000 U.S. children. NIAID-funded research led to the development of antiretroviral agents that suppress HIV to undetectable levels in the body—keeping people with HIV healthy and preventing HIV transmission. Further, Protease inhibitors used in HIV treatment contributed to the development of direct-acting antivirals that cure hepatitis C. NIAID-funded research enabled development of mRNA vaccines in the first 100 days of the COVID-19 pandemic, which saved millions of lives worldwide and allowed the global economy to recover. NIAID scientists developed new technologies to identify geographic hot spots for Aedes mosquitoes—a type of mosquito that can spread diseases such as dengue, Zika, and chikungunya. The tool is poised to deliver targeted interventions to fight dengue and other diseases in the U.S. and communities across the globe. Asthma affects one in 13 Americans, including 20 million adults and over 5 million children. A clinical trial funded through NIAID found that the monoclonal antibody mepolizumab reduced asthma attacks by 27% in children and adolescents with severe asthma. An estimated 50 million Americans suffer from one or more autoimmune diseases, including 1.3 million adults with rheumatoid arthritis (RA). NIAID researchers discovered a new species of bacteria in the gut that may trigger RA, offering new avenues for treatment and prevention. Tuberculosis (TB), particularly in its drug-resistant forms, is not only a lethal threat globally (killing 410,000 per year), but remains a threat to the American people. NIAID has provided significant funding for noncommercial translational research – ranging from early discovery-based efforts to late-stage preclinical development – to develop novel anti-TB medicines. This is of fundamental importance, as research in potentially promising compounds has often been challenged by the inability to attract predictable, long-term funding that NIAID has been able to provide. These investments have led to continued breakthroughs in developing new TB treatments. NIAID-supported research is a bridge from the bench to the bedside, bringing together the full spectrum of the biomedical research and healthcare communities in addressing antimicrobial resistance. Each year, drug-resistant infections impact more than 3 million Americans, killing at least 50,000 people in the U.S. It is projected that AMR could become the leading cause of death globally by 2050 and cost the global economy $100 trillion. NIAID is instrumental in the development and training of the next generation of biomedical researchers and sustaining the current biomedical workforce. Further investments in biomedical workforce development at NIAID will yield far-reaching dividends for global health, global health security, and scientific diplomacy. We urge you and your colleagues to work towards finalizing FY 2025 funding bills to avoid longterm continuing resolutions or a government shutdown and to ensure strong funding for the life-saving work of NIAID so that American ingenuity can continue to forge a healthier, safer, and more equitable world for all. Sincerely, American Society for Microbiology American Society for Virology American Society of Tropical Medicine and Hygiene AVAC Drugs for Neglected Diseases initiative Elizabeth Glaser Pediatric AIDS Foundation Global Health Council Global Health Technologies Coalition HIV Medicine Association HIV+Hepatitis Policy Institute IAVI Immune Deficiency Foundation Infectious Diseases Society of America Research!America TB Alliance Texas Biomedical Research Institute Treatment Action Group

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Recently published results from a Phase 3 clinical trial support Pfizer and Abbvie’s aztreonam-avibactam as a potential treatment for patients with serious gram-negative bacterial infections and limited treatment options. Aztreonam-avibactam is a combination of two antibiotic drugs that work together to effectively fight off tricky bacteria resistant to nearly all currently available antibiotics. The treatment was approved in April by the European Medicines Agency based on the results of two previous Phase 3 clinical trials that investigated the treatment's efficacy in treating several types of multidrug-resistant infections.Last week, TB Alliance announced the award of a $7.35 million four-year grant from the US Department of Defense’s Congressionally Directed Medical Research Programs for the research and development of host-directed approaches for treating tuberculosis (TB). Host-directed approaches, which target the immune response of the host (the infected person) rather than directly targeting the bacteria, could reduce the likelihood of the emergence of drug resistance and, in combination with new TB drugs, could offer shorter and less long and burdensome treatment regimens for those with drug-resistance and drug-sensitive TB. Specifically, the project will work toward preclinical proof-of-concept for at least one novel adjunct TB host-directed therapy and one therapeutic vaccine.At the HIV Research for Prevention Conference last week, the Population Council announced the results of a Phase 1 trial conducted in South Africa, which suggest that the three-month dapivirine vaginal ring for HIV prevention will be as effective as the one-month ring. The three-month dapivirine vaginal ring, a flexible silicon ring self-inserted into the vagina that slowly releases an antiretroviral drug to prevent HIV infection, was found to deliver the drug at higher levels than the one-month ring. If the longer-acting ring continues to demonstrate success in future trials, it could offer a more cost-effective and convenient option for women—it is expected to reduce the cost per user by 60 percent.