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.A combo flu and COVID-19 vaccine developed by Novavax elicits a strong immune response similar to stand-alone flu and COVID-19 shots, according to initial results of a phase 1/2 trial announced last week. The trial, conducted among 642 older adults between 50 to 70 years old in Australia, sought to identify an optimal dose of the vaccine using a modeling-based approach. The shot generated a similar immune response to both a stand-alone influenza vaccine as well as a stand-alone COVID-19 shot, and the modeling showed the combined formulation could reduce the total antigen amount by up to 50 percent, which could boost production and delivery. Novavax is launching a phase 3 study to continue evaluating the combination vaccine.BenevolentAI and the Drugs for Neglected Disease initiative (DNDi) have launched a joint research project to combat dengue, for which there is currently no effective treatment. The collaboration will use an AI-enhanced approach—using a data foundation developed from various independent data sources—to identify the underlying mechanisms involved in dengue infection and provide a host of potential biological targets and drug repurposing candidates that could help stop progression to severe dengue. Once the most promising drug candidates are identified, they will be evaluated in clinical trials in partnership with dengue-endemic countries. Applying cutting-edge AI technology to help neglected patients opens an exciting opportunity to rapidly identify and evaluate promising drug candidates, according to DNDi.The first open-air study of genetically engineered mosquitoes in the United States is now complete and shows promising results, according to biotechnology firm Oxitec, which is running the experiment. The experiment, launched in April 2021, involved releasing nearly 5 million engineered Aedes aegypti mosquitoes in the Florida Keys over the course of seven months. Oxitec’s engineered male mosquitoes carry a gene that is lethal to female offspring, causing the population to dwindle as each generation mates. While the experiment showed females did die as intended due to the gene, larger tests are still needed to determine whether the insects can achieve the ultimate goal of suppressing a wild population of potentially virus-carrying mosquitoes, and controlled clinical trials will be required to assess whether the method reduces transmission of dengue or other viruses carried by A. aegypti.

Malaria is one of the world’s oldest and deadliest diseases. Thanks to international efforts to develop and scale up prevention tools and treatments, significant gains have been made over the past few decades in fighting this dangerous disease. But challenges, such as growing drug and insecticide resistance and disruptions from COVID-19, have hampered control efforts. Unfortunately, in 2020, both malaria cases and deaths increased significantly from the prior year—indicating progress against the disease has stalled and underscoring the need for continued research and development of new tools.In recognition of #WorldMalariaDay, test your knowledge of this deadly disease and the innovations being advanced to #EndMalaria:

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. On Thursday, the US Food and Drug Administration (FDA) granted emergency use authorization to the first COVID-19 test to detect the disease through breath. The InspectIR COVID-19 Breathalyzer is able to identify five volatile organic compounds associated with COVID-19 infection in breath samples and delivers results in less than three minutes. In a study of 2,409 individuals both with and without symptoms, the test had a 99.3 percent specificity rate, which measures the percent of correctly identified negative test samples, and a 91.2 percent sensitivity rate, which measures the percent of correctly identified positive test samples. The breathalyzer device—about the size of a piece of carry-on luggage—will be used in mobile testing sites, hospitals, doctor’s offices, and other locations where samples are both collected and analyzed.An experimental drug halved the death rate among critically ill COVID-19 patients receiving supplemental oxygen and at high risk for serious lung disease and death, the drug’s developer announced last week. Sabizabulin, which works by disrupting the transport of the virus through microtubules in cells, is given in a capsule taken once a day and has no refrigeration requirements. A clinical trial of the drug, the results of which have not yet been published or peer reviewed, was halted early at the recommendation of independent safety monitors after the treatment was shown to drastically reduce deaths among hospitalized COVID-19 patients. Developers plan to meet with the FDA later this month and will be applying for emergency use authorization for sabizabulin.An anti-HIV strategy called vectored immunoprophylaxis—in which an adeno-associated viral (AAV) vector delivers instructions to muscle cells to pump out antibodies that block the virus—showed promising results in a phase 1 clinical trial conducted by the National Institutes of Health. The AAV therapy is able to block HIV’s ability to bind to an immune cell’s receptor that the virus targets before infecting the cell, therefore shutting down the virus’s entry. The phase 1 clinical trial enrolled eight adults with HIV who were on stable antiretroviral therapy for at least three months and found that intramuscular injection of the therapy was safe and well-tolerated. Researchers are continuing to develop this technology, which they say could have wide-ranging clinical implications for preventing or treating HIV and other infections.

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.On Thursday, the World Health Organization launched a new global initiative to combat arboviruses—fast-growing and poorly understood viral diseases carried by insects that have future pandemic potential. The Global Arbovirus Initiative aims to tackle diseases like dengue, yellow fever, chikungunya, and Zika, which currently have limited effective treatments and vaccines. The initiative will better link the various research, surveillance, and vector control efforts around the world in a more formal network of collaboration. Research innovation and partnerships are also key to the new strategy, which is the culmination of a series of consultations among a broad network of partners to enable efficient and successful collaboration across a range of pathogens and disciplines and ensure a more integrated approach to this family of viruses.The US Food and Drug Administration on Tuesday approved HIV treatment Cabenuva for adolescents, the first long-acting injectable regimen for the age group. The treatment, which includes shots of cabotegravir and rilpivirine, was approved for adults last year as a monthly regimen and more recently as a bimonthly regimen, meaning it can be administered as few as six times per year. Both timing options will now be available to virologically suppressed adolescents aged 12 years or older who weigh at least 35 kg, are on a stable antiretroviral therapy regimen, and have no history of treatment failure or resistance to either drug. The approval for adolescents is supported by evidence from studies conducted among adults as well as from interim analysis of an ongoing trial among adolescents.Ahead of a World Health Assembly (WHA) meeting in May, the United Kingdom is circulating a resolution to improve the quality of clinical trials by boosting funding, adding more trial sites, and fully reporting study results. The proposal, which comes amid increased concerns about meeting global health needs in the wake of COVID-19, promotes steps to generate “high-quality research” that can help develop medical products to provide routine care, especially in lower- and middle-income countries, for any global health priority. These steps include coordinating research, ensuring funding, and creating mechanisms to register trials and report results. If the resolution proceeds after member state debate, revisions are expected between now and the WHA session in early May.