Ansley Kahn

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 Friday, the World Health Organization (WHO) launched the findings of its malaria eradication report, a three-year long analysis of the global fight against the mosquito-borne disease, calling for “transformative tools and knowledge” to achieve eradication. A summary of the report noted that current tools are not sufficient to wipe out the disease and urged scientists and global health funders to invest in research and development (R&D) of new vector control technologies, vaccines, and medicines to prevent and treat the disease. Currently, less than one percent of investment in health R&D goes to developing tools to tackle malaria. The report calls attention to the funds, tools, and political will needed to control the disease considering WHO data which shows that progress against malaria is stalling after a decade of significant decline in malaria cases and deaths. A phase 3 study from GSK’s ViiV Healthcare showed an injection of its drug cabotegravir and Johnson & Johnson’s Edurant (rilpivirine) could work just as well when given every two months as it does as a monthly therapy. An application of this two-drug injectable regimen as a once-monthly injection has already been put under US Food and Drug Administration priority review with a decision expected by December 29. In two earlier phase 3 trials, the long-acting injectable therapy was found to be as effective as both an oral three-drug regimen of two nucleoside reverse transcriptase inhibitors plus a third agent and ViiV’s own triple drug therapy, Triumeq, in reducing viral load. These results demonstrate progress in efforts to reduce the number of medicines a person living with HIV must take as well as the frequency of treatments. British technology and energy company, Sure Chill, has developed a refrigerator to protect medical supplies, such as vaccines, from power outages. Vaccines are often temperature sensitive to both high and low temperatures, which presents a major challenge for health workers in low-resource settings with limited or unreliable electricity supplies. The refrigerator works by harnessing a natural phenomenon. The refrigerator has a cold compartment that is surrounded by water that cools when connected to power, forming a layer of ice above the chamber. When the electricity is shut off, the warm water rises as the ice melts, keeping the water at a consistent temperature for up to four weeks without power. The refrigerator has kept more than 20 million vaccinations cold and has been approved for use by the WHO.

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 first vaccine against chlamydia—one of the most common sexually transmitted infections—has proven to be safe and effective in a phase 1 clinical trial. The trial tested two different versions of the vaccine and though both elicited an immune response, one performed better than the other. Further testing will proceed with that version. Due to the complexity of the bacterium, researchers posit that a successful vaccine must provoke a strong immune response both with antibodies to fight bacteria outside of the cells, and immune system protein and cells to help clear the bacteria from infected cells. Approximately 131 million people are infected with chlamydia each year. If left untreated, it can cause chronic pelvic pain and infertility in women. Last Wednesday, the US Food and Drug Administration (FDA) approved a new drug, pretomanid, for treatment of highly drug-resistant tuberculosis (TB). Pretomanid, developed by TB Alliance, was approved as part of a three-drug, six-month, all-oral regimen, which also includes bedaquiline and linezolid—collectively known as BPaL. In a clinical trial, 95 out of 107 patients had a successful outcome after six months of treatment with the regimen. The historical treatment success rate is 34 percent. Pretomanid is only the third FDA-approved anti-TB drug in more than 40 years, though TB remains the world’s number one infectious disease killer. In what is being hailed as a landmark announcement, two antibody-based therapies have proven to dramatically improve the survival rate of people newly infected with Ebola in a clinical trial conducted in the Democratic Republic of the Congo (DRC)—raising hope that the yearlong epidemic in the DRC and future outbreaks of the virus can be more easily contained. The two treatments, REGN-EB3, developed by Regeneron Pharmaceuticals, and mAb114, developed by the National Institute of Allergy and Infectious Diseases, were among four therapies tested as part of a clinical trial that began in November. These two treatments will now be offered to all patients, with experts recommending that the other two therapies involved in the clinical trial be stopped. The yearlong Ebola outbreak in the DRC, which was declared a public health emergency by the World Health Organization last month, has infected 2,800 people and killed more than 1,800 people.

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. Researchers at Purdue University have created a device that can rapidly detect the bacterium which causes cholera in water. Unlike traditional tests, which require a well-equipped laboratory and three to five days to process results, this device acts as a portable “cholera detection lab” built around a smartphone. A water sample is placed in a single-use, disposable test kit which uses chemicals that make copies of the toxin gene in cholera bacteria in a process called amplification. If the water becomes more viscous, it signals that harmful bacteria has been identified and the imaging system on the smartphone will capture the results, which can be sent to researchers or charities who can address the water quality issue. The device is currently in early field testing. The nonprofit Sabin Vaccine Institute (Sabin) has acquired the rights from GSK to develop three experimental, single-dose vaccines for Marburg virus, Ebola Sudan, and Ebola Zaire—the strain of the Ebola virus responsible for the yearlong outbreak in the Democratic Republic of the Congo (DRC). Sabin will develop these vaccines in collaboration with the National Institutes of Health Vaccine Research Center, whose scientists originally designed the vaccines which all use the same approach to induce immunity. Though the vaccines have not been tested in phase 3 trials, which would show their efficacy in preventing infection, a phase 2 trial conducted at the end of the West African Ebola outbreak showed that the Ebola Zaire vaccine produced an antibody response in most recipients that lasted up to a year. The largest-ever trial of a preventive Ebola vaccine in Uganda began last week, amid fears of the virus spreading from neighboring DRC. The two-year trial, which will test a two-dose Ebola candidate vaccine developed by Janssen Pharmaceuticals of Johnson & Johnson, will involve 800 participants picked from core health workers and non-core personnel in the Mbarara district, located in the southwest of the country, and will assess the vaccine’s safety and efficacy in inducing an immune response to prevent the disease. The trial will be conducted by both Ugandan and international researchers and is sponsored by the London School of Hygiene and Tropical Medicine. Ebola has killed more than 1,800 people in the DRC during this latest outbreak, which began over a year ago.

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 National Institutes of Health (NIH) is hoping that an ambitious effort to create a “Google” for biomedical research could help researchers connect the dots between health data sets to unlock new scientific insights and discoveries. Launched by NIH in 2016, the Biomedical Data Translator program is attempting to create a tool that would integrate different data sources, ranging from electronic health records to clinical trial results, and apply machine learning techniques to reason through the information allowing researchers to make connections between not previously associated datasets and identify trends across them. So far, the program has awarded approximately US$17.5 million to 19 institutions across the country working to integrate and organize years of data. The initial feasibility phase of the project is set to end this year. Surveys conducted by the World Health Organization (WHO) in 18 countries from 2014 to 2018 reveal an alarming surge in resistance to critical HIV drugs. In the past four years, 12 countries in Africa, Asia, and the Americas have surpassed the acceptable levels of drug resistance against two key HIV drugs, efavirenz and nevirapine—showing more than ten percent of adults with HIV have developed resistance to these drugs in these nations. Though the causes of drug resistance are unclear, the co-author of a WHO report on the survey’s findings suggests drug-resistant HIV may develop when people interrupt treatment. In response to this evidence, WHO recommends that countries use dolutegravir as first-line treatment against HIV since the likelihood the virus will develop resistance is lower with dolutegravir than with other antiretrovirals. The Coalition for Epidemic Preparedness Innovations (CEPI) will provide biotech company, Valneva, with up to $23.4 million to fund the development of a single-dose, live-attenuated vaccine for Chikungunya—a mosquito-borne disease which causes fever, severe joint pain, muscle pain, and fatigue. The funding from CEPI will support vaccine manufacturing and late stage clinical development to help accelerate regulatory approval of the vaccine for use in regions where outbreaks occur. Valneva plans to maintain a stockpile of the vaccine and transfer its manufacturing to Chikungunya-endemic regions. Since Chikungunya re-emerged in 2004, approximately 3.4 million cases in 43 countries have been identified.

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 World Health Organization (WHO) has changed its guidelines to strongly recommend the antiretroviral medication dolutegravir (DTG) as the preferred first- and second-line treatment for all people living with HIV, including pregnant women. Last year, many countries advised pregnant women, or those who might become pregnant, to take efavirenz (EFV) instead of DTG after a study in Botswana found a possible link between DTG and serious birth defects in newborns. Presenting new research from the ongoing study at the International AIDS Society Conference on HIV Science, WHO stated that the potential risk for birth defects was significantly lower than previously estimated, with benefits for women outweighing drawbacks. Preliminary testing of an implant containing a new antiretroviral drug, islatravir, in a dozen patients over 12 weeks suggests that it may protect against HIV infection for a full year. The implant, a matchstick-sized plastic rod inserted just under the skin of the upper arm, slowly releases tiny doses of islatravir, which lingers in the body for a relatively long time so it can be given less than other medications. Unlike some other HIV drugs, islatravir is absorbed into the anal and genital tissues where most infections start and is less likely to give rise to drug-resistant strains since it attacks a different stage in the infection process. The implant could help those at risk of HIV infection, particularly women in Africa, who are looking for prevention methods that are easier to use and conceal. Large clinical testing is required to determine the safety and efficacy of this implant in protecting against HIV infection. Malaria drugs are failing at an alarming rate in Southeast Asia as drug-resistant strains of the disease emerge, according to two new reports released in The Lancet—prompting global concern that this drug resistance could spread around the world. One of the studies, performed in the greater Mekong region, compared a new three-drug malaria regimen against the conventional two-drug artemisinin combo—used to treat the majority of malaria cases—when researchers noticed the antimalarial drugs in the current regimen weren’t fully wiping out the deadly parasites. The overall failure rate was 50 percent, but in some parts of the region the drugs weren’t working nine times out of ten. If drug resistance to first-line malaria drugs continues to spread, it could mean major setbacks to the global effort to control the mosquito-borne disease.

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. An experiment on two islands near the southern Chinese province of Guangdong successfully reduced the female Asian Tiger Mosquito population—a highly invasive species that is the main source of bites and disease transmission—by up to 94 percent, reducing the number of reported human bites by 97 percent. In the study, female mosquitoes were sterilized with low level radiation and males infected with Wolbachia bacteria to inhibit reproduction. Both the female and male mosquitoes were then released during the peak breeding seasons in 2016 and 2017—resulting in a near-eradication of the entire female mosquito population on both islands. Given there are no effective vaccines or treatments for many mosquito-transmitted diseases, controlling the insect’s population is one of the most effective control methods, according to the International Journal of Science. A new project is being launched by Gavi, the Vaccine Alliance to test whether using biometric data as part of medical records can help boost vaccination rates among children. The trial in Bangladesh and Tanzania will fingerprint up to 20,000 children between the ages of one and five in existing health projects, using biometric data to track their vaccinations and link them to computer medical records that will replace paper-based records. Simprints, a UK-based nonprofit specializing in biotechnology in the field of international development, will manage the fingerprint collection effort. Simprints’ technology has already been fine-tuned to work with fingerprints from individuals in poor and rural communities, who are more likely to have worn, scarred, or burned fingertips. Japanese company NEC Technologies is also partnering on the project to provide image processing and matching algorithms to complement Simprints’ scanning hardware and apps. The US$3 million project is due to begin later this year and conclude in 2020. Johnson & Johnson will test an experimental HIV vaccine—a mosaic-based preventative immunization that targets multiple strains of the virus—in the United States and Europe sometime this year. The company is also conducting a phase 2 clinical trial for the vaccine in Africa involving 2,600 women in five southern African countries. Initial results from the African trial are expected in 2021. This trial comes amid other recent advancements in HIV and AIDS research. In April, Johnson & Johnson and GlaxoSmithKline majority-owned ViiV Healthcare filed a new drug application with the US Food and Drug Administration for its once-a-month injection treatment for HIV, which in late-stage trials was shown to be as effective in controlling HIV as daily pills.