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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. The International Vaccine Institute (IVI) has initiated a technology transfer, first announced last year, of the simplified Oral Cholera Vaccine (OCV-S) to Indian company Biological E. Limited. In the face of an unprecedented rise in cholera outbreaks around the world in recent years, the technology transfer aims to increase the volume of affordable cholera vaccines in the Indian and international markets. IVI is providing technical information, know-how, and materials to support clinical development and regulatory approvals of the vaccine. OCV-s is a simplified formulation of the Oral Cholera Vaccine that can lower production costs while increasing capacity for manufacturers.The Bill & Melinda Gates Medical Research Institute last week announced the launch of a Phase 3 trial evaluating a vaccine for tuberculosis (TB), which researchers hope could become the second licensed vaccine for TB in more than 100 years. The adjuvanted subunit vaccine M72/AS01E was originally developed by GSK, Aeras, and IAVI. The trial, funded by the Bill & Melinda Gates Foundation and the Wellcome Trust, is testing the vaccine’s ability to prevent latent TB from progressing to active pulmonary TB in adults and adolescents. If successful, the pivotal trial could lead to a new tool with the potential to transform TB control globally.A research team from the University of Pittsburgh School of Medicine has identified drug candidates that demonstrate the potential to eliminate the HIV viral reservoir that cannot be expelled completely by existing antiretroviral drugs, preventing people who have undetectable viral load from being completely cured of HIV. The drug candidates, which are called proteolysis targeting chimeras, or PROTACs, can trigger the degradation of the viral protein that prevents the immune system from destroying infected cells by hiding signs of the virus on the surface of the cell. Through this method, the drugs show promise in reversing the ability of HIV to evade detection by the immune system. The PROTAC approach still has significant hurdles to go before it can be used in humans, including preclinical testing in animal models and medical chemistry optimization.

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. A new study that tested Gilead’s antiviral drug, obeldesivir, in primates given a lethal dose of the Ebola Sudan virus found that the drug may be effective in curing infections from the Sudan strain, for which there are currently no approved vaccines or treatments. The study tested a regimen of once-daily pills for ten days. If proven effective in humans and approved, it would be the first oral treatment for any subspecies of Ebola. Moreover, the drug can be stored at room temperature and is relatively inexpensive to manufacture, especially compared to the monoclonal antibodies approved for Ebola Zaire. Previous work in cell culture also showed that obeldesivir seems to work against all known species of Ebola and the related Marburg virus. Further research could confirm the drug's use as a pan-ebolavirus therapy; however, running clinical trials will prove challenging as there are long stretches between outbreaks of Ebola Sudan, in particular.A new initiative led by Imperial College London and co-funded by the Coalition for Epidemic Preparedness Innovations (CEPI) aims to develop next-generation coronavirus vaccines that not only reduce disease severity but also stop viral transmission, reducing the spread of disease. The project will deliberately infect healthy human volunteers with betacoronaviruses, including the virus that causes COVID-19, to test the efficacy of vaccines that are administered via nasal spray. Experts believe this method could be more effective in triggering the highly specialized mucosal immunity that can stop transmission by directly acting at the cells lining the nose, throat, and lungs—where the viruses enter the body. The human challenge trial design of the project is also unique. Imperial College London last year announced that the world’s first COVID-19 human challenge trial was safe, paving the way for broader use of this approach.A research team has discovered an enzyme in the species of sandfly that is primarily responsible for the spread of leishmaniasis in South America that they hope will lead to the development and commercialization of targeted traps to control the insect population and reduce the spread of the disease. Leishmaniasis can be disfiguring, and the severe form, visceral leishmnasis, which mostly occurs in Brazil, can be lethal if left untreated. The researchers analyzed the genome of the Lutzomyia longipalpis, a species of sandfly native to Brazil and South America, and identified the enzyme, Terpene Synthase, which is responsible for making the pheromone used to attract mates, a discovery that could be leveraged for future control technologies.

The newly published report from GHTC and Policy Cures Research, Doing Well by Doing Good: Why Investing in Global Health R&D Benefits the United States and the World, which looks at the returns from US investment in global health R&D, was featured in articles from Research Professional News, CIDRAP, Infosalus, and Health Tech World.

Analysis reveals that over a 16-year period, $46 billion in U.S. public funding generated dozens of new tools for fighting HIV, TB and other global threats; boosted economic performance at home and abroad; and is likely to spur $102 billion in industry investments Over the last 16 years, U.S. government funding for research and development (R&D) targeting global health challenges supported dozens of breakthrough innovations while generating billions of dollars in economic benefits, both global and domestic, and spurring a surge of industry investments, according to a new analysis from the Global Health Technologies Coalition (GHTC) and Policy Cures Research (PCR). “Public funding for global health R&D is small, relative to the incredible returns it provides for fighting neglected and emerging diseases like malaria, HIV, tuberculosis, Ebola and COVID-19 — and for stocking the pipeline with many promising new technologies,” said Dr. Kristie Mikus, GHTC’s executive director. “The innovations emerging from this work are important for advancing health and opportunity globally and for addressing America’s increasing vulnerability to infectious diseases.” Dr. Nick Chapman, CEO of PCR, said, “Our analysis shows that the $46 billion invested by the U.S. government between 2007 and 2022 has not only delivered a steady stream of new drugs, vaccines and prevention tools, but has also supported basic research that is expected to attract an additional $102 billion investment from industry.” The report, Doing Well by Doing Good, looks at the return on investment from federal funding for global health R&D that flows through agencies such as the National Institutes of Health, Biomedical Advanced Research and Development Authority, the U.S. Agency for International Development, and the U.S. Centers for Disease Control and Prevention. This funding helps to support work targeting historically neglected diseases such as malaria, HIV and tuberculosis (TB); more recently emerging threats that include COVID-19, Ebola, chikungunya and mpox; and sexual and reproductive health issues. The report notes that new tools are urgently needed because these challenges cause a massive loss of life around the world, impede economic progress in low- and middle-income countries, and pose a growing threat to Americans — especially with climate change facilitating the spread of disease.  For example, in the fight against neglected and emerging infectious diseases (other than COVID-19), the report found the funding contributed to the development of 67 new health technologies that have been approved since 1999. This includes 12 new products for fighting Ebola, which continues to spark new outbreaks; 12 for TB, a resurgent disease fueled by an alarming spread of drug-resistant strains; and 11 for malaria, which is once again on the rise globally and recently caused a surprising spate of locally acquired cases in the U.S.The report found the investments also are supporting a product development pipeline for neglected and emerging diseases that now includes 261 promising innovations in late-stage development. Many carry the potential to deliver major benefits in reducing the human and economic toll of these threats.  New global health tools now available or close to fruition that benefited from recent U.S. government investments include: A new drug, pretomanid, whose addition to a treatment regimen for TB has dramatically improved outcomes and reduced costs for treating patients infected with drug-resistant strains of the disease. Switching all patients with drug-resistant TB to pretomanid-based regimens could generate global health care cost savings of $740 million annually.  Two new long-acting HIV prevention options have the potential to transform global HIV prevention efforts by offering an alternative to daily pills for at-risk groups. Long-acting cabotegravir, delivered via a single bi-monthly injection, could avert 45% of new infections in the U.S. and up to 28% of potential future HIV infections in low- and middle-income countries. The dapivirine vaginal ring, a monthly product offering discreet protection, is another breakthrough option for use by women at high risk of infection. The U.S. government’s multi-agency Operation Warp Speed supported development of four COVID-19 vaccines that have since been deployed around the world. These vaccines contributed to saving 14.4 million lives in the first year of the pandemic alone. Also, between December 2020 and March 2022, they played a prominent role in the estimated $895 billion in direct health care costs savings linked to vaccination.Powerful new monoclonal antibodies or mAbs have emerged for fighting Ebola and malaria. Two approved mAbs for treating Ebola were found to significantly decrease mortality, to 11% for one of the drugs and 6% for the other, compared to 54% in untreated patients. Meanwhile, three promising mAbs for preventing malaria are in clinical development. There is already evidence for one of these mAbs indicating a potential to reduce infections by 54%–75% in communities where malaria emerges as a seasonal threat. The report also notes that U.S. investments in global health R&D are delivering considerable economic benefits globally and domestically.  From 2007 to 2022, U.S. funding supported R&D capacity and product manufacturing capabilities in 43 low- and middle-income countries along with health innovations that can reduce the financial burden of neglected and emerging infectious diseases. For example, in countries where malaria is common, new drugs and vaccines can dramatically reduce the costs of managing the disease, which can consume up to 8% of a family’s budget and reduce national GDP by 1.3%. In the United States, the report estimates that from 2007 to 2022, the $46 billion in public spending on global health R&D created 600,000 new jobs, generated $104 billion in economic activity and supported basic research endeavors that are on track to catalyze $102 billion in additional industry investments. And it’s the gift that keeps on giving. By supporting basic research that will continue to inspire health innovations for years to come, the report finds that it’s likely the $46 billion in public funding ultimately will generate $255 billion for the American economy — a six-fold return on investment. (A companion analysis from GHTC available here explores the funding impact on a state-by-state level, which includes stimulating tens of thousands of jobs in top research states like Maryland, Massachusetts, California, Virginia, North Carolina, Washington state, New York, New Jersey, Pennsylvania and Georgia.)  The report points out that Americans also benefit because funding for global health R&D is delivering tools for threats that are increasingly viewed as potential domestic risks. For example, the report notes that climate change is facilitating the spread of insect-borne pathogens into the continental U.S., including Chagas disease, dengue, Zika, chikungunya and malaria.“The irony is that despite producing blockbuster returns, public funding for global health R&D is not keeping pace with growing needs and rising risks,” said Dr. Mikus. “R&D funding for emerging threats largely has been reactive — mainly focused on emergencies like Ebola, Zika and COVID-19 — and R&D budgets for neglected diseases actually dropped 11% in 2022. We encourage policymakers to look at global health R&D as one of the best investments a government can make, right up there with roads, schools and national defense.”  ### About the Global Health Technologies Coalition The Global Health Technologies Coalition (GHTC) works to save and improve lives by encouraging the research and development of essential health technologies. We bring together more than 45 nonprofit organizations, academic institutions, and aligned businesses to advance policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people. About Policy Cures Research Policy Cures Research is an independent, not-for-profit, research and policy organisation providing strategic analysis and decision-making tools for those involved in the creation of new health technologies for neglected diseases, emerging infectious diseases and sexual & reproductive health issues. Its focus is on providing governments, funders, researchers and civil society organisations with the insights they need to make optimal R&D policy and funding decisions for diseases affecting the world’s most vulnerable populations. For more information, please contact: Katy Lenard at klenard@burness.com or +1 301-280-5719