Breakthroughs Blog: BARDA

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 week, scientists in Rwanda and partners from the World Health Organization launched the world’s first clinical trial testing a treatment for the deadly Marburg virus amid the ongoing outbreak in the country. There are currently no approved treatments or vaccines against Marburg virus, although a clinical trial of Sabin Vaccine Institute’s investigational vaccine is currently underway in Rwanda. The new trial will investigate the safety and efficacy of remdesivir and the monoclonal antibody MBP091, developed by Mapp Biopharmaceutical with support from the Biomedical Advanced Research and Development Authority.  At the recent G7 Joint Finance and Health Ministers’ Meeting, the Italian government announced a $21 million commitment over the next three years to the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to accelerate the development of innovative products to prevent, diagnose, and treat drug-resistant bacterial infections. AMR is a growing public health crisis, particularly in low- and middle-income countries, and there is an urgent need for international collaboration and investment to revitalize an inadequate clinical pipeline and ensure new antimicrobials, antimicrobial alternatives, and diagnostics are available for patients worldwide.Valneva and LimmaTech announced last week that their Shigella4V (S4V) vaccine has been awarded Fast Track designation by the US Food and Drug Administration. There are no approved vaccines for the Shigella bacteria, which causes shigellosis, the second leading cause of fatal diarrheal disease globally, particularly among children in low- and middle-income countries. S4V is the world’s most clinically advanced tetravalent bioconjugate vaccine for shigellosis. This designation will enable accelerated clinical development and review of the vaccine, which will be investigated in two Phase 2 trials that are expected to begin before the end of 2024.

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.

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 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.