Breakthroughs Blog: COVID-19

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 Wednesday, The New England Journal of Medicine published the full results of the PURPOSE 2 trial testing Gilead Science’s twice-yearly lenacapavir shot for HIV prevention, finding that it was extremely effective in a broad and geographically diverse range of cisgender men and gender-diverse people. These results follow those of the first PURPOSE trial published earlier this year, which found that the drug was 100 percent effective as a prevention option in a study of women and adolescent girls. Lenacapavir is already approved and available in several countries, including the United States, as an HIV treatment option. With additional approvals as an HIV prevention option, the shot could be a game-changer for many marginalized communities that face the highest risk of HIV infection.A recent study found that the investigational drug quabodepistat in combination with delamanid and bedaquiline demonstrated safety and efficacy as a treatment for pulmonary tuberculosis (TB). TB treatment has historically been months long and difficult to tolerate, leading to discontinued treatment courses that raise the risk of the emergence of drug resistance. This combination treatment could potentially help fill the gap for safer, shorter regimens that cause fewer side effects. Further large-scale and long-term trials will be needed to validate these findings before this treatment combination can be available to the communities that face the highest burden of TB.Last week, the US Department of Health and Human Services announced nearly $27 million to support the rapid development and scale-up of manufacturing capacity for diagnostic tests to address future biologic threats through the Biomedical Advanced Research and Development Authority consortium. The COVID-19 pandemic exposed the gap in the United States' capacity to quickly develop, validate, produce, and roll out diagnostic tests to curb the spread of an infectious disease outbreak. While the funding will specifically support the development of tests to detect Burkholderia pseudomallei, the bacterium that causes melioidosis, and Marburg virus, the aim is to advance diagnostics platforms that can be leveraged to quickly produce tests for other threats as they emerge.

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. Two recent studies found that the virus that causes COVID-19 is developing resistance to two antiviral drugs commonly used for treatment in patients with compromised immune systems: remdesivir and nirmatrelvir. The first study from Cornell University and US National Institutes of Health researchers, which specifically looked at immunocompromised patients, found that the virus developed a reduced sensitivity to the drugs, while the second study from University of Pittsburgh, Brigham and Women’s Hospital, Stanford University, and Harvard University researchers also found resistant mutations, with the effect more evident in the immunocompromised and those who had received nirmatrelvir. These results raise concerns as the threat of antimicrobial resistance globally grows.Researchers from the University of California, Riverside; the University of California, Irvine; and the Yale School of Medicine have designed a new synthetic compound, MED6-189, which is effective against drug-sensitive and drug-resistant Plasmodium falciparum malaria strains in vitro and in mice engineered to have human blood. MED6-189, inspired by a compound extracted from marine sponges, works by targeting and disrupting a specialized part of P. falciparum cells, as well as the pathways used to transport materials within the cells, thereby preventing the pathogen from developing resistance. The next steps include continued optimization of the MED6-189 and further confirmation of its mechanisms of action, but, if the compound continues to demonstrate success, this research could lead to the development of an important tool to address the rising challenge of antimalarial drug resistance.Last week, the US Department of Health and Human Services through the Advanced Research Projects Agency for Health announced funding for the Transforming Antibiotic R&D with Generative AI to stop Emerging Threats project that will use artificial intelligence (AI) to speed up the discovery and development of new classes of antibiotics to meet the urgent need for new drugs amid the growing threat of antibiotic resistance. While conventional antibiotic discovery methods require time-consuming manual screening and testing of potential molecular compounds, most of which do not advance into further development, this project will employ deep learning to develop new methods to identify biomolecules with potential and use generative AI to expand the number of potential antibiotic candidates.

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 Biomedical Advanced Research and Development Authority (BARDA) has awarded an agreement worth up to $268 million over 12 years to Swiss company Basilea Pharmaceutica to support the development of novel, first-in-class antifungals and antibacterials in its portfolio. The initial funding will specifically serve the further development of fosmanogepix, which is expected to enter soon a Phase 3 trial for invasive yeast infections, and BAL2062, which has the potential to target the common mold Aspergillus and has most recently completed a Phase 1 safety study. The news comes as investment in new antimicrobials continues to wane and the threat of antimicrobial resistance continues to rise globally.A recent study found that the protection offered by the Jynneos mpox vaccine greatly wanes 6 to 12 months after vaccination, raising concerns about the need for booster doses and the potential of breakthrough infections among vaccinated people amid the ongoing global mpox emergency fueled by the severe clade 1b of the virus. The Jynneos vaccine is meant to be given as two doses a month apart, but to offer protection to more people and to conserve a limited supply of doses, many were offered just one dose early on in the 2022 clade 2 mpox outbreak. The study found that after one year, the antibody levels in participants who had two doses were comparable or lower than the peak antibody responses in people who had received only one.The US National Institutes of Health (NIH) recently announced a new network that will research pathogens that currently lack effective treatments and vaccines to identify strategies to develop safe and effective medical countermeasures before a new pandemic threat arises. The network, which comes in the wake of the COVID-19 pandemic and the midst of ongoing emerging infectious disease outbreaks, will focus on developing tools that target viral families that are known to cause human disease, such as the families that include dengue and yellow fever, measles, polio, and chikungunya. The agency’s National Institute of Allergy and Infectious Diseases has committed up to $100 million annually to the network.