Breakthroughs Blog: Medicines

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 US Department of Defense is providing US$71 million for increased production of Inovio Pharmaceutical’s Cellectra devices—small, hand-held tools that are used to deliver Inovio’s vaccine candidate, INO-4800, directly to the skin without the use of needles. The device works by using a small electrical pulse that enables the DNA-based virus to pass into the recipient’s skin. Cellectra operates on AA batteries, and it is designed to "function reliably in challenging environments and can be stockpiled in large quantities without maintenance.” The vaccine, INO-4800, is expected to remain effective for up to one year in room-temperature storage. These durable qualities could make this vaccine system effective for low-resource settings. Inovio expects to begin a phase 2/3 trial in July. On Wednesday, the University of Oxford launched the first clinical trial in Africa of a COVID-19 vaccine. The vaccine being evaluated, AZD1222, was invented at the University of Oxford and is being developed in partnership with AstraZeneca. The trial is being conducted in South Africa, which has 120,000 of the continent’s 340,000 total cases. It represents a key moment for a continent that has so far been elbowed out of the global competition for medical supplies during the pandemic. Africa Centers for Disease Control and Prevention Chief John Nkengasong said, “unless we act now, Africa is at risk of being left behind on the global vaccine.” Others noted that several African countries have clinical trial capacities to contribute to global research and development. The University of Oxford is also running trials of AZD1222 in Brazil and Britain.Remdesivir, the first drug to demonstrate a benefit for treating COVID-19, has so far been delivered intravenously but will now be evaluated in an inhalable form in clinical trials. The inhalable version will be delivered via a nebulizer, a tool commonly available in the United States. Scientists at Gilead, remdesivir’s sponsor, hope that the availability of nebulizers will make it easier to use remdesivir at earlier stages of infection, such as when a patient tests positive but is presymptomatic. While delivering remdesivir as an inhalant may help overcome some of the limitations of intravenous delivery, it may also present other issues. Some physicians are worried that using a nebulizer could enable the spread of viral particles, and at improper doses, remdesivir can be toxic.

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.Dexamethasone, an inexpensive, decades-old drug is showing promise for treating COVID-19, per unpublished, preliminary results from a study called Recovery that was funded by the United Kingdom. The preliminary results indicated that the drug reduced the risk of death for patients on ventilators by 35 percent, those receiving oxygen by 20 percent, and overall mortality by 17 percent. Immediately following the results, the United Kingdom granted approval for use of the drug to treat COVID-19. According to FiercePharma, UK officials have enough dexamethasone stockpiled to treat 200,000 patients.  A recent study lends support to anecdotal evidence that blood type and genetics may be linked to worse outcomes from COVID-19 illness. Last Wednesday, a team of European researchers published a study in The New England Journal of Medicine indicating that people with type A blood have a 45 percent higher risk of catching COVID-19 and sliding into respiratory failure and people with type O blood have a 35 percent lower risk of developing respiratory failure compared to people with other blood types. Scientists are still unsure why blood type might be correlated with COVID-19 outcomes, but a nascent hypothesis is that it could be linked to blood clotting risk. The researchers also found that a cluster of genes are associated with higher risk of developing severe COVID-19 by 77 percent.A project led by researchers from Scripps Research, GHTC member IAVI, and the University of California San Diego School of Medicine published research in Science detailing a set of antibodies discovered in recovered COVID-19 patients that provide powerful protection against SARS-CoV-2. In theory, the antibodies could be given to patients who are just developing the illness to prevent progression to severe disease and to protect people who are at higher risk for contracting COVID-19. To discover the antibodies, the scientists isolated more than 1,000 distinct antibody-producing immune cells, obtained genetic sequences from these cells to produce more antibodies, and then tested the antibodies’ effectiveness against blocking the virus in vitro. The researchers discovered several antibodies that, even in small quantities, could block the SARS-CoV-2 virus. The work was funded by the US National Institutes of Health, IAVI, and the Bill & Melinda Gates Foundation, among others.

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. As part of Operation Warp Speed, the Trump Administration has selected five top COVID-19 vaccine candidates to receive priority government support. The candidates include mRNA-1273 (Moderna and the National Institute of Allergy and Infectious Diseases), AZD-1222 (AstraZeneca and Oxford University), Ad26 SARS-Cov-2 (Johnson & Johnson), and candidates from Merck/IAVI and Pfizer. The Merck/IAVI and Pfizer candidates have not yet received federal funding, but as selected companies, they will receive access to government support to advance their programs. The mRNA-1273 and AZD-1222 candidates are already in phase 2 clinical trials and are expected to reach phase 3 in July. Officials anticipate that each vaccine will be tested on 30,000 individuals in phase 3 trials, some of which may take place outside the United States. An official announcement about the selection of these five companies is expected from Operation Warp Speed in the next few weeks.Convalescent plasma, sourced from patients who have recovered from COVID-19, did not demonstrate significant effectiveness as a treatment in the first randomized clinical trial evaluating its use. The Wuhan-based trial, however, fell short of its target recruitment because of containment of the outbreak and only enrolled 103 of the 200 patients needed to demonstrate a clinically meaningful result. In the same journal, Dr. Arturo Casadevall of the Johns Hopkins School of Public Health said that, though there was no significant improvement, the study gave “potentially hopeful signals” and that convalescent plasma should be tested in combination with antiviral drugs.The World Health Organization (WHO) launched at the end of May the COVID-19 Technology Access Pool, or C-TAP, a global project to share intellectual property and speed the research, development, and deployment of new vaccines, tests, treatments, and other health tools for COVID-19. The voluntary pool was initiated by Costa Rica and is supported mostly by low and middle-income countries and only a few high-income countries. Notably, many countries that are leading the research race for new tools, including the United States, the United Kingdom, France, Germany, and Switzerland, have not supported C-TAP. Meanwhile, some leaders from the pharmaceutical industry have dismissed the project while other groups, such as the Médecins Sans Frontières’ Access Campaign, have given praise.

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. In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. An HIV vaccine candidate has shown promising results in human trials. A study in the Lancet found that this “mosaic” vaccine—comprised of pieces of different HIV strains—produced an anti-HIV immune system response in tests on 393 people. Further testing is required to determine if the immune response produced can prevent the HIV infection in people. In the next phase of testing, 2,600 women from southern Africa who are at risk of contracting HIV will receive the vaccine. This is one of only five HIV vaccine candidates to ever make it to this stage of efficacy trials. Paraguay has eliminated malaria, becoming the first country in the Americas to achieve this milestone in approximately a half-century, according to the World Health Organization. Public health officials have credited the national health system’s ability to quickly detect cases and determine whether they had been transmitted locally or imported as critical to Paraguay’s success. Though Paraguay has thwarted the threat of malaria for the moment, nine countries in the Americas reported at least a 20 percent increase in malaria cases between 2015 and 2016. Complacency and lack of political will in other countries in the region threaten the fight against malaria. Scientists at the California Institute for Biomedical Research are testing a new approach to tackling malaria and other insect-borne diseases using a group of veterinary drugs called isoxazolines. When administered orally to animals, isoxazolines remain in the bloodstream for up to three months, killing blood-sucking insects by damaging their nervous systems. The researchers believe isoxazolines have the potential to dramatically reduce the transmission of malaria, as any mosquito who bites a person who has taken this drug would be killed before transmitting the disease to other people. The study published by the California Institute for Biomedical Research estimates that giving 30 percent of the population isoxazolines in countries affected by malaria could prevent more than 70 percent of malaria infections. Researchers believe that isoxazolines are safe for human consumption and plan to continue to evaluate their efficacy.