Research Roundup: First mpox vaccine prequalification, PURPOSE 2 HIV PrEP results, BARDA Ebola treatment contract
Global Health Technologies Coalition (GHTC)
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TOP NEWS IN R&D
WHO prequalifies the first vaccine against mpox WHO news release (9/13)
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.
With another Phase 3 win, Gilead races toward 2025 launch for long-acting PrEP drug Fierce Pharma (9/12)
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.
NEWS FROM GHTC
IDSA, ESCMID call for 'robust action' on antimicrobial resistance ahead of UN meeting CIDRAP?(9/12), features the Infectious Diseases Society of America
Rich nations have millions of mpox shots: Will they share with Africa? Reuters?(9/12), features Public Citizen
Triple antibody therapy shows promise for long-lasting HIV control NewsWise?(9/12), features the Bill & Melinda Gates Foundation
Parasitologists up in arms as NIH ends funding for key database Science (9/11), features the American Society of Tropical Medicine and Hygiene
HIGHLIGHTS FROM THE WEEK
Atea finally gives up COVID ambitions after antiviral fails to reduce hospitalizations, deaths in Phase 3 Fierce Biotech?(9/13)
Novel antifungal candidate gets financial boost CIDRAP?(9/12)
Sanofi completes build out of $554M pandemic-ready modular plant for vaccines, biologics Fierce Pharma?(9/12)
GSK's mRNA flu vaccine finally overcomes tricky B strains in Phase 2 trial Fierce Biotech?(9/12)
California officials confirm local dengue case CIDRAP?(9/11)
Mpox and cholera outbreaks underscore importance of Gavi’s African vaccine initiative – but can it ensure equity? Health Policy Watch?(9/10)
Opinion:?Big Pharma lacks motive to prep for new pandemics Reuters?(9/10)
SARS-CoV-2 rapidly evolves in people with advanced HIV NIAID Now?(9/9)
Whatever happened to ... the Brazilian besties creating an mRNA vaccine as a gift to the world NPR?(9/9)
领英推荐
MPOX R&D ROUNDUP
Morocco reports first mpox case Reuters?(9/12)
Canada to donate 'up to 200,000' doses of mpox vaccine Reuters?(9/11)
AVIAN FLU R&D ROUNDUP
H5N1 confirmed in 3 more California dairy herds CIDRAP?(9/11)
Bird flu has already appeared in these New York markets. What’s next? The New York Times?(9/9)
UPCOMING EVENTS
September 17-18 2024 National Health Research Forum Virtual; Washington, DC
September 18 Webinar: "Mycetoma: Understanding the disease, seeking solutions" Virtual
September 19 Webinar: "An introduction to antibiotic research and development (R&D)" Virtual
September 25 UNGA side event: “Racing against antimalarial resistance: Driving global action to support national response efforts” New York, New York
September 26 UNGA side event on gender-responsive climate policies for health equity New York, New York
October 8-10 Global Forum on TB Vaccines Rio de Janeiro, Brazil
October 16-19 IDWeek 2024 Los Angeles, California
October 17 Research in Action Awards New York, New York
October 22 North Carolina Global Health Conference Raleigh, North Carolina
November 13-17 ASTMH Annual Meeting New Orleans, Louisiana
November 18-21 2024 Global Health Landscape Symposium Virtual; Washington, DC
December 5 GHIT R&D Forum 2024 Tokyo, Japan
February 4-5 Antimicrobial Chemotherapy Conference 2025 Virtual
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