Breakthroughs Blog: Research Roundup

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. Pfizer and BioNTech last week reported promising early-phase data on an mRNA combination vaccine against COVID-19 and influenza and announced plans to start a phase 3 trial of the vaccine, following Moderna’s similar announcement for its combination vaccine earlier this month. Moderna’s trial began last week, with Pfizer and BioNTech’s likely to start in the coming months as well. A combination vaccine for COVID-19 and influenza has the potential to greatly reduce the burden of these respiratory viruses on patients, providers, and health care systems, underscoring why these companies and the broader research community have placed a greater focus on combination vaccines coming out of the pandemic.At the annual meeting of the American Society of Tropical Medicine and Hygiene (ASTMH) last week, the World Health Organization reported the results of a major evaluation of a pilot rollout in three African countries of RTS,S, the first approved malaria vaccine, showing positive findings about the lives it has already saved. RTS,S cut deaths among young children by 13 percent over nearly four years and cut cases of severe malaria by 22 percent among kids young enough to have received a three-shot regimen. The RTS,S vaccine is notably not a perfect tool, given the limited durability of its protection and lower efficacy, but health experts say this data makes a strong case for broader rollout of RTS,S and the potential of integrating the second approved malaria vaccine, R21, into multipronged efforts to fight malaria.A research team at the Johns Hopkins Bloomberg School of Public Health has shown for the first time that human volunteers can be safely and effectively infected with Zika virus, which could benefit research efforts to gain a greater understanding of the disease and to develop vaccines and treatments to use against it, as none currently exist. This controlled human infection model is useful for research because during the 2015-2016 outbreak, researchers were unable to test experimental products in time before the epidemic subsided, and since, there have not been any large outbreaks. The new model is controversial but has been ruled by US regulators and the World Health Organization as safe and scientifically important.

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. Johnson & Johnson on Friday presented new data showing that its pill for dengue fever appeared to protect against a form of the virus in a small human challenge trial done with the Johns Hopkins School of Public Health, providing hope for the first-ever specific treatment for dengue, which is a growing threat around the world due to climate change. The pill, which is the first-ever drug to show antiviral activity against dengue, will also be tested as a treatment method. If the drug is successful in larger-scale trials, ensuring access to the new drug in low- and middle-income countries —especially as the threat of dengue rises in high-income countries alike—will be essential to effectively tackle the disease around the world.The Sabin Vaccine Institute has launched a phase 2 clinical trial for its vaccine candidate against Marburg virus, a lethal filovirus for which there are currently no vaccines or antiviral treatments approved. The trial will take place in Kampala, Uganda, which has experienced various Marburg outbreaks in the past few decades. The single-dose candidate was previously found to be safe and elicit rapid and robust immune responses in phase 1 clinical and non-clinical studies. The ChAd3 platform, which forms the basis of the Marburg vaccine candidate, also undergirds Sabin's Sudan ebolavirus vaccine candidate, which recently received US funding for phase 2 clinical trials. The need for a vaccine against both deadly diseases has been brought to the fore by recent outbreaks.Last week, Gilead Sciences Inc. announced PURPOSE 5, the first phase 2 clinical trial to evaluate an investigational, long-acting HIV prevention option in Europe. Lenacapavir for HIV prevention, compared with a currently used drug combination, could offer a fewer-dose, long-acting solution to individuals who could benefit from pre-exposure prophylaxis (PrEP). Lenacapavir, which can be administered as a twice-yearly injection, is currently approved in combination with other antiretrovirals for HIV treatment in people with multidrug-resistant HIV-1 infection. The study has an intentional focus on recruiting participants who are disproportionately affected by HIV and often underrepresented in clinical trials, given the importance of making available a variety of HIV prevention methods to meet the diverse needs of those who could benefit from PrEP.

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 US Department of Health and Human Services announced another $500 million in Project NextGen funding, which will support phase 2b clinical trials of three COVID-19 vaccine candidates, as well as other technologies to enhance preparedness against COVID-19 and future disease outbreaks. Specifically, the awards will go to two intranasal vaccine candidates that are administered as sprays and one self-amplifying mRNA vaccine candidate that is administered as an injection; phase 2b clinical trials of those vaccine candidates could start as soon as this winter. Funding will also go to the development of vaccine patches, cold-chain sample management, genomic sequencing, and increased laboratory capacity.The Coalition for Epidemic Preparedness Innovations (CEPI) is leading an initiative with the biopharma data provider IQVIA aimed at enhancing global research capacity to advance the 100 Days Mission, which aims to be able to respond to the next Disease X (a future pathogen with pandemic potential) with medical countermeasures within 100 days of its identification. Under the initiative, IQVIA will provide tools and resources to support research preparedness in underserved regions during ‘peacetime’ (when there is no ongoing pandemic outbreak) and to support clinical trials during future outbreaks of diseases with pandemic potential. CEPI will fill in gaps to ensure high-quality data are generated during an outbreak response to inform further research.Last week, The Lancet and the Coalition for Preventing Pandemics at the Source announced that they have convened the Commission on Prevention of Viral Spillover, which will work to mobilize decision-makers to support research and policies to prevent future viral spillovers and pandemics following the COVID-19 pandemic, which was the fifth viral pandemic caused by a viral spillover in the last century. The commission, which includes 28 experts in a variety of fields from epidemiology to veterinary medicine to food systems management, will conduct original research and publish a comprehensive report within two to three years on recommendations to prevent such spillovers.

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 Wednesday, Moderna announced that its combination COVID-19 and flu shot, mRNA-1083, demonstrated strong immunogenicity in a phase 1/2 trial. The trial found that mRNA-1083 was similarly effective to two already approved flu vaccines developed by GSK and Sanofi and Moderna’s own SpikeVax COVID-19 vaccine. There were also no new safety concerns reported with the combination vaccine compared to each of the vaccines used alone. A phase 3 trial testing the combination shot will begin before the end of the year with potential regulatory approval in 2025 if successful. The company also laid out its broader efforts on combination vaccines, including a combination shot for COVID-19, flu, and respiratory syncytial virus.The Biomedical Advanced Research and Development Authority (BARDA) has awarded Vir Biotechnology $50 million in Project NextGen funds to advance the development of novel monoclonal antibody (mAb) candidates and delivery solutions for COVID-19 and future pandemic threats.  The new funding will support development of alternative mAb delivery technologies that increase antibody expression relative to existing solutions, which could revolutionize mAb delivery by expanding administration options and shortening development and manufacturing timelines. Four-fifth of the funding will specifically go toward advancing Vir’s next-generation COVID-19 mAb, Vir-7229, through a phase 1 trial, expected to be completed in late 2025, while the remainder will support the discovery of new mAbs against a second pathogen of pandemic potential.The World Health Organization (WHO) last week recommended the R21/Matrix-M malaria vaccine, developed by the University of Oxford. This follows two years after WHO recommended RTS,S, the first malaria vaccine. Both vaccines have a similar efficacy profile and delivery method and are targeted to children, but doses of R21 are expected to be cheaper—between $2.00 and $4.00 compared to about $7.25 now charged for RTS,S. The Serum Institute, which will produce R21, has also announced plans to deliver a much higher volume of doses compared to GSK’s current marketing plans for RTS,S. Although it will take more time to collect further safety monitoring data for R21, the recommendation of a second vaccine will hopefully help to ensure adequate supply for malaria-endemic countries that are planning to integrate a vaccine into their national malaria control plans.