Research Roundup: HIV prevention option safe in pregnancy, Pharmacy-based COVID trial, New RSV monoclonal antibody

TOP NEWS IN R&D

Long-acting injectable cabotegravir for HIV prevention is safe in pregnancy National Institute of Allergy and Infectious Diseases news release (7/23), features the Bill & Melinda Gates Foundation

The results of a new study presented at the 2024 International AIDS Conference showed that long-acting injectable cabotegravir was safe and well tolerated as an HIV pre-exposure prophylaxis method in cisgender women before and during pregnancy. These exciting results come from an extension study of the efficacy trials among cisgender women that analyzed the outcomes of more than 300 pregnancies and infants. There has been limited data on the safety of long-acting injectable cabotegravir during pregnancy, so hopefully, these findings can fill that knowledge gap and lead to greater access to this highly effective HIV prevention option for this population, who may experience biological changes and social dynamics that can increase their likelihood of acquiring HIV during and after pregnancy.

HHS announces pharmacy-based clinical trial under Project NextGen CIDRAP?(7/23)

Last week, the Administration for Strategic Preparedness and Response at the US Department of Health and Human Services announced $25 million in funding to Walgreens to support a decentralized clinical trial testing COVID-19 vaccines. The study specifically aims to identify vaccine correlates of protection, or measurable immunity markers that correlate with protection against disease, using licensed or authorized COVID-19 vaccines to help assess immunity duration and streamline future clinical trials. This decentralized approach, which will include about 20 Walgreens pharmacies in urban, suburban, and rural communities, allows for a more diverse pool of study participants by bringing the study closer to where participants live. The funding comes through Project NextGen, a US government-led program to accelerate the development of next-generation COVID-19 technologies, including vaccines.

Merck & Co.’s mAB prevents RSV in infants, teeing up talks with regulators Fierce Biotech (7/23)

New data shows that Merck & Co.’s monoclonal antibody is safe and effective at reducing the incidence of respiratory syncytial virus (RSV)-related infections in infants. The Phase 2b/3 trial tested clesrovimab, also known as MK-1654, in healthy pre-term and full-term infants, finding that the antibody reduced the incidence of RSV-related infections over 150 days when compared to a placebo and hit key safety measures. The company announced that detailed findings will soon be presented to the scientific community and filed with global regulators. Hopefully, the antibody will eventually serve as an additional tool in the growing toolkit of new vaccines and monoclonal antibodies to address the burden of RSV in infants and older adults.

NEWS FROM GHTC

New clinical trial will assess if mpox vaccination works after virus exposure Coalition for Epidemic Preparedness Innovations press release (7/27)

Opinion: HIV 'morning after drug' can help end this pandemic Devex?(7/23), features the Gates Foundation and Jhpiego

Dengue fever is — unfortunately — having a banner year. Can it be quelled? NPR?(7/23), features the Drugs for Neglected Diseases initiative

Experimental Lyme disease vax passes milestone Axios?(7/23), features Valneva

HIGHLIGHTS FROM THE WEEK

Predica Diagnostics developing targeted sequencing test for cervical cancer diagnosis, screening 360Dx?(7/26)

Doctor behind trial of HIV prevention drug recounts breakthrough moment The Guardian?(7/26)

Opinion:?The basket of HIV prevention options needs to be filled Times Live?(7/25)

Scientists say they developed faster way to diagnose, treat sepsis CIDRAP?(7/25)

UK group to fund multidisciplinary research into antimicrobial resistance CIDRAP?(7/25)

FDA grants Emergency Use Authorization for Nano-Ditech's Flu/COVID point-of-care test 360Dx?(7/24)

Dissolvable birth control pill Femlyv gets FDA approval Medical Professionals Reference?(7/24)

UK regulator authorises updated Pfizer-BioNTech COVID shot targeting JN.1 strain Reuters?(7/24)

NIH reports isolated HIV tests may result in false positive in some patients on PrEP 360Dx?(7/24)

How global health institutions and funders can empower local researchers Devex?(7/24)

Experts say a twice-yearly injection that offers 100% protection against HIV is ‘stunning’ Associated Press?(7/24); Additional coverage from?The Guardian?(7/23)

GSK’s Dovato matches Gilead’s HIV juggernaut Biktarvy with less weight gain in Spanish trial Fierce Pharma?(7/23)

Opinion:?How to reduce the risk of a catastrophic lab accident The New York Times?(7/23)

New push for mpox research funding, as cases surge Nature?(7/22)

Nuclein submits combo COVID, flu point-of-care RT-qPCR test for FDA 510(k) clearance, CLIA waiver 360Dx?(7/22)

AVIAN FLU R&D ROUNDUP

Could cow vaccines help halt the spread of bird flu in U.S. herds? Experts are divided STAT?(7/29)

Drugmaker Sinergium to share bird flu vaccine data globally, says WHO Reuters?(7/29)

The CDC’s test for bird flu works, but it has issues KFF Health News?(7/26)

UN agency seeks urgent response to 'alarming' spread in Asia-Pacific bird flu Reuters?(7/25)

China reports fatal H5N6 avian flu case CIDRAP?(7/25)

Testing transmission and infection of H5N1 from cows NIH Research Matters?blog (7/23)

Opinion: There are no good options left with bird flu The Atlantic (7/23)

How to pinpoint the H5N1 mortality rate in humans Undark?(7/22)

Avian flu infects two more Colorado poultry cullers, one at second farm CIDRAP?(7/22)

UPCOMING EVENTS

July 29-30 Global Pandemic Preparedness Summit 2024 Rio de Janeiro, Brazil

July 30 Congressional briefing: "Understanding the power and possibility of clinical trials" Washington, DC

August 22 Webinar: "Exploring non-traditional antimicrobials: Insights from three cases" Virtual

October 8-10 Global Forum on TB Vaccines Rio de Janeiro, Brazil

November 13-17 ASTMH Annual Meeting New Orleans, Louisiana

December 5 GHIT R&D Forum 2024 Tokyo, Japan

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