Breakthroughs Blog: Mpox

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 Friday, the World Health Organization (WHO) announced the prequalification of Bavarian Nordic’s MVA-BN vaccine for mpox, the first-ever vaccine for the virus on the prequalification list. Prequalification status is anticipated to facilitate timely and increased access to the vaccine, helping to contain the current outbreak on the African continent by accelerating procurement by governments and international agencies and enabling national regulatory authorities to fast-track additional approvals. The vaccine has been licensed for use in people 18 years and older with a two-dose schedule given a month apart. However, the WHO Strategic Advisory Group of Experts has specifically recommended the use of the vaccine for people at a high risk of exposure in the context of an outbreak; thus, the vaccine has been used in infants, children, adolescents, and pregnant and immunocompromised people. It has also recommended single-dose use to stretch limited supplies while also urging the need to collect additional data about the vaccine’s safety and efficacy in these circumstances.Last week, Gilead published new results from the highly anticipated PURPOSE 2 trial, the second Phase 3 study of its twice-yearly, long-acting drug for HIV pre-exposure prophylaxis (PrEP), lenacapavir. The trial showed that the drug was able to reduce HIV infections by 96 percent compared with background HIV incidence and was 89 percent more effective than Gilead’s already available PrEP drug, Truvada. The study, which included more than 3,000 cisgender men, transgender men and women, and gender non-binary individuals aged 16 and older across seven countries, was unblinded early to offer lenacapavir to all patients in the study. This news follows the exciting results from the PURPOSE 1 trial of the drug in cisgender women and adolescent girls, which demonstrated 100 percent efficacy and was also unblinded early. Lenacapavir is currently available for use alongside other agents in patients with multidrug-resistant HIV, which make up only 2 percent of adults living with HIV, but, if approved for additional populations, the drug could be available as soon as 2025 and could be a game-changer for the HIV epidemic. Emergent BioSolutions last week announced that the Biomedical Advanced Research and Development Authority (BARDA) awarded the company a $41.9 million research and development option to its existing ten-year contract to further the development, validation, commercialization, and scale-up of the company’s monoclonal antibody treatment for Ebola virus infection. The treatment, Ebanga, was initially developed by Ridgeback Biotherapeutics with support from BARDA and was approved by the US Food and Drug Administration as a single infusion for the treatment of Ebola Zaire virus infection in 2022. The award is part of BARDA’s broader strategy to support treatments that can be deployed during virus outbreaks.

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 research team from Brazil has identified a potential target for a novel therapeutic to combat infections caused by Aspergillus fumigatus, a fungal species that, alongside other Aspergillus fungi, can cause potentially fatal complications in patients with weakened immune systems and is listed by the World Health Organization as a priority fungal pathogen. The researchers are now working to find a molecule that can inactivate the target identified by the research and potentially serve as the basis for a novel drug to target the fungus. This discovery comes in the face of rising resistance to existing antifungals, an absence of newly approved ones in recent years, and often unpleasant side effects that can accompany those that are currently available. A recently published study found that Moderna’s mRNA vaccine candidate was better than the currently available Jynneos vaccine at preventing severe mpox and reducing virus levels in monkeys. Moderna started advancing preclinical development for an mpox vaccine candidate during the last declared public health emergency of international concern for the virus in 2022. The candidate, mRNA-1769, contains mRNA molecules that code for four proteins on the surface of the mpox virus that are vital for viral replication and that are shared by other orthodox viruses. The candidate was able to neutralize other orthopox viruses, including camelpox, rabbitpox, and multiple mpox strains, in lab tests, suggesting that the vaccine could provide broad protection against a range of orthopox viruses, as well as offer a potentially safer, more effective, and easier- and quicker-to-manufacture alternative for mpox. A multi-institution research team discovered and isolated a broadly neutralizing antibody that could form the basis of a future treatment for current and future variants of the rapidly mutating virus that causes COVID-19. The researchers isolated a plasma antibody from a single patient that was broadly neutralizing—or able to neutralize all known variants of SARS-CoV-2, the virus that causes COVID-19, as well as distantly related SARS-like coronaviruses that infect other animals—and then obtained the exact molecular sequences of the antibody in the hopes of being able to manufacture it as a future treatment, as well as enable research toward a universal vaccine. This discovery provides some hope as cases of COVID-19 spike once again.

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 (WHO) asked manufacturers to submit mpox diagnostic tests for emergency review in an effort to speed up and broaden access to effective testing amid the mpox emergency on the African continent. WHO has also updated its mpox testing guidance and is working with countries to roll out testing, with 30,000 tests expected to arrive in African countries in the coming weeks. Manufacturers Labcorp and Roche have also said that they are working to increase their mpox testing capacity.The Coalition for Epidemic Preparedness Innovations (CEPI) will provide $2.05 million to South African biotech company Afrigen Biologics for a proof-of-concept project to investigate whether synthetic DNA could serve as an alternative to the traditional plasmid DNA used for mRNA vaccine development, cutting timelines and costs. The partnership supports the 100 Days Mission of reducing vaccine development timelines to just 100 days after identifying a disease outbreak with pandemic potential. The project could help further optimize mRNA vaccine development—which is already much faster and more flexible than traditional vaccines—in the face of an outbreak, as well as enable local manufacturing of vaccines in Africa, which could help facilitate more equitable access to vaccines.Last week, IAVI announced that the first participants at trial sites in Ghana, Liberia, and Nigeria had been vaccinated in a clinical trial of IAVI’s Lassa fever candidate. Lassa fever, for which there is limited treatment and no available vaccine, causes an estimated 300,000 cases across West Africa annually, and the threat is expected to grow due to climate change and population growth. The trial, funded by CEPI and designed in consultation with in-country partners, will evaluate the candidate’s safety, tolerability, and immunogenicity at two different dosage levels in adults, including people living with HIV, as well as in adolescents and children two years and older. The trial results are expected in 2025.

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 recently published study found that a malaria vaccine candidate given to women who planned on becoming pregnant was safe and effective for both the women and their babies. This exciting research could lead to a vaccine to protect pregnant individuals— who are often excluded from clinical trials—and their babies from malaria in the face of an estimated 50,000 maternal deaths and 200,000 stillbirths every year caused by malaria infections in pregnancy. The investigational attenuated vaccine, PfSPZ, will next be tested for use during pregnancy and in a larger study on preconception use. Just as the World Health Organization and the Africa Centres for Disease Control and Prevention declared the current mpox outbreak a public health emergency last week, SIGA Technologies and the National Institute of Allergy and Infectious Diseases at the US National Institutes of Health reported mixed results from a preliminary analysis of a study testing the smallpox antiviral treatment Tpoxx against mpox. While the study, which took place in the Democratic Republic of Congo and began during the 2022 global outbreak, did not meet the trial’s primary endpoint of reducing the time to lesion resolution within a 28-day treatment period, the company says these results are not entirely unexpected and is highly encouraged that Tpoxx did elicit a “meaningful improvement” in some participants with severe cases, supporting a potential use case as post-exposure treatment for patients with severe mpox. The company also pointed to four other ongoing studies that significantly differ from the Congo trial and will provide additional data on the treatment.The NxTAG Respiratory Pathogen Panel, which detects and differentiates between common respiratory viruses, recently received 510(k) clearance from the US Food and Drug Administration. The combination test, which was developed with support from the Biomedical Advanced Research and Development Authority (BARDA) can, from a single swab, detect and differentiate 19 common respiratory viruses, including the virus that causes COVID-19, influenza A and B, and RSV, allowing health care workers to test patients and provide appropriate treatment rapidly. BARDA’s support is part of a broader effort to advance diagnostic testing platforms that can be rapidly adapted to emerging threats.