Linksbridge Pharma: this week's highlights
Mpox: new vaccine and drug studies on the horizon
Bavarian Nordic’s mpox vaccine will be evaluated in pregnant women, breastfeeding women and infants in the DRC, thanks to an $8.1 million joint investment from CEPI and the Global Health EDCTP3. A CEPI press release last week said the “first-of-its-kind” Phase 3 trial will assess Jynneos?in about 350 women who will receive the jab before or after giving birth, as well as 250 children ages 6-24 months who will receive a full or half-dose of the shot. The study will start early next year, per the press release.
On the therapeutics front, Africa CDC and the Pandemic Preparedness Platform for Health and Emerging Infections Response (PANTHER) initiative are launching the continent’s first trial to find effective mpox treatments. Africa CDC announced last week that the study—set to begin this year in the DRC and neighboring countries—will evaluate Maryland-based Emergent BioSolutions’?smallpox drug Tembexa (brincidofovir) in at-risk people.
Study makes case for BBIL TCV booster
Protection stemming from a dose of Bharat Biotech’s WHO-prequalified TCV waned three to five years after vaccination, suggesting the need for a booster dose around school entry age for those who received their first dose as young children, according to results from a Bangladesh-based study published last month in The Lancet.
The Bill & Melinda Gates Foundation-backed follow-up study—which extended a previous study in children who received the jab between 2018 and 2021—assessed the protection of Typbar TCV for up to five years in children ages 9 months to 15 years at vaccination. While children vaccinated at ages 2 and older were well protected after three to five years, vaccine effectiveness in children who received the jab before age 2 dropped from 85% to 24%.
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TB short-course safe in children under 2
A study has confirmed the safety of the 3HP TB preventative regimen in children under age 2—long-awaited results that will help fill the gap in data on the safety, tolerability and correct dosing for the regimen in the youngest children.
That’s according to a Wednesday statement from the Community Research Advisors Group—an advisory body coordinated and hosted by the Treatment Action Group—which cited data presented at the 2024 Union World Conference on Lung Health in Bali. Conducted by the TB Trials Consortium at the U.S. CDC, the South Africa-based Phase 1/2 study evaluated the isoniazid and rifapentine regimen in children ages 0-12 years with tuberculosis infection, including those living with HIV.
Arcturus moves samRNA H5N1 vaccine to Phase 1
Arcturus Therapeutics has notched U.S. FDA clearance to launch a Phase 1 trial of its self-amplifying mRNA vaccine candidate targeting H5N1 pandemic influenza, the San Diego biotech announced Monday. The company plans to evaluate ARCT-2304 in approximately 200 healthy adults in the BARDA-funded U.S.-based trial.
Additional stories from our November 13 issue:
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