Breakthroughs Blog: NIH

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, the National Institute of Allergy and Infectious Diseases awarded Kephera Diagnostics two Small Business Innovative Research grants, totaling $5.7 million, for the development and testing of immunoassays for Lyme disease and Chagas disease. The company’s Lyme disease immunoassay could simplify diagnosis by eliminating the need to perform one of the two steps now used in the screening and confirmatory testing process. Kephera’s immunoassay for Chagas disease is designed to monitor treatment response in patients, as current drugs vary in efficacy in adults with chronic infections. It is being developed both for laboratory use and use in the field.A phase 1 trial evaluating a novel preventive HIV vaccine candidate, VIR-1388, has begun enrollment in the United States and South Africa. VIR-1388 is designed to prompt the immune system to produce T cells that can recognize and signal an immune response to prevent the virus from establishing chronic infection. It delivers vaccine material using a cytomegalovirus (CMV) vector, whose discovery and development was funded by the National Institute of Allergy and Infectious Disease (NIAID). Because CMV, while harmless, remains detectable in the body for life, researchers hope this vector will help the body retain the vaccine material for a longer period of time, overcoming the waning immunity seen with other candidate vaccines. The trial is sponsored by Vir Biotechnology with support from NIAID and the Bill & Melinda Gates Foundation.Last week saw the launch of a third phase 1 clinical trial of the ChAdOx1 vaccine candidate for Middle East Respiratory Syndrome (MERS). If eventually approved, the vaccine would be a game-changing tool against the viral illness, for which there are no approved vaccines or treatments, and which is recognized by the World Health Organization as a priority pathogen with epidemic potential, especially in light of new cases reported this year. The University of Oxford’s Pandemic Sciences Institute started developing the vaccine for MERS before the COVID-19 pandemic, and the research for ChAdOx1, which was put on pause during the pandemic, enabled the rapid development of the Oxford/AstraZeneca vaccine for COVID-19.

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, Indian drug company Cipla confirmed that a generic version of the HIV prophylaxis long-acting cabotegravir (CAB-LA) will be manufactured at its plants in South Africa for the first time, which could potentially offer millions of people at risk of HIV infection in Africa access to the groundbreaking drug. CAB-LA is a two-monthly jab that is easier to take regularly and has also been found to work better than the daily HIV prevention pill, which is currently available for free in South Africa and several other countries on the continent. The introduction of generic manufacturers into the market for HIV drugs has the potential to dramatically reduce medicine prices, which are often out of reach for low- and middle-income countries, even at prices discounted by the manufacturers that hold the original patents.IAVI and Zendal Group’s subsidiary Biofabri have signed an expanded deal to develop MTBVAC, the only live, attenuated mycobacterium tuberculosis (TB) vaccine in the pipeline. The developers are targeting the vaccine for use in adults and adolescents and are aiming for the candidate to be more effective and potentially longer lasting than the bacillus Calmette-Guérin, or BCG, vaccine that is currently in use to prevent TB in newborns. IAVI is planning to commence a trial for the MTBVAC in 2024 after sufficient funding is secured. The deal also includes support for advancing MTBVAC for infants following Biofabri commencing a phase 3 trial of MTBVAC in neonates last year.Last week, the US National Institutes of Health announced that they are beginning to enroll patients in an early-stage clinical trial testing an mRNA universal flu vaccine that is aimed at protecting against a wide variety of strains of the flu and providing long-term immunity. The shot, designed by researchers at the National Institute of Allergy and Infectious Diseases, will test whether the shot is safe and produces an immune response in 50 healthy adult volunteers. If proved to be safe and effective, a universal flu vaccine could eliminate the need for scientists and vaccine manufacturers to predict the dominant flu strain and produce shots in advance of prime flu season, as well as reduce the risk of illness and hospitalization, particularly when the shots available are not well matched to the dominant circulating strains.

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 Thursday, the World Health Organization (WHO) officially launched its mRNA vaccine technology hub in Cape Town, South Africa. During the COVID-19 pandemic, the facility was established in response to global vaccine access inequity to pursue mRNA vaccines for COVID-19 and potentially other poverty-related diseases. South African biotech firm Afrigen Biologics and vaccine producer Biovac are working with the publicly available sequence of Moderna’s mRNA COVID-19 vaccine to create a similar vaccine candidate, which will be tested on humans early next year. The candidate will the first to be made based on a widely used vaccine (like Moderna’s) without the developer’s approval and assistance and the first mRNA vaccine designed, developed, and produced at lab scale on the African continent.The White House plans to nominate cancer surgeon Dr. Monica Bertagnolli to become the director of the US National Institutes of Health (NIH), succeeding Dr. Francis Collins, who stepped down in 2021. Dr. Bertagnolli has served as the director of the National Cancer Institute since last fall. If confirmed by the Senate, she will inherit COVID-19 pandemic-era challenges around increased scrutiny of the agency’s funding of virus research, including grants to EcoHealth Alliance, which studied coronaviruses in Wuhan, China.Two studies published last week found that repurposed drug combinations lowered the risk of severe COVID-19 in high-risk patients. Stanford University researchers looked at the combination of the antidepressant fluvoxamine and the corticosteroid budesonide among nonhospitalized adults with early symptomatic COVID-19 and at least one risk factor. A second team from Weill Cornell Medicine looked at the combination of the monoclonal antibodies amubarvimab and romlusevimab in nonhospitalized adult COVID-19 patients with high-risk factors. Using combinations of repurposed drugs to treat severe COVID-19 (if successful in further testing) could prove to be an important tool in reducing the burden of COVID-19 in low- and middle-income countries, where oral therapeutics for COVID-19 are largely unavailable.

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 World Health Organization (WHO) recently warned about the limited pipeline of new antibiotics for drug-resistant bacteria in a report based on a review published by WHO in 2022. The report found that only 12 new antibiotics entered the market between 2017 and 2021. Additionally, the report found that although 27 experimental antibiotics for critical bacterial infections are in clinical development, only 6 of those are considered different enough from existing antibiotics to potentially be used against drug-resistant pathogens without concern. Without a steady stream of novel antibiotics entering the pipeline and market, bacterial infections will become increasingly dangerous as bacteria continues to develop resistance to existing drugs.A new study from researchers at HDT Bio found that a new type of RNA vaccine against HIV and the Zika virus generated strong antibody responses in pregnant rabbits and their offspring. More studies will be necessary to confirm that vaccinating the mother alone is enough to protect against infection in the offspring, as well as to optimize vaccination timing and to see if the results can translate to humans. If successful, the vaccine could be an important tool in preventing mother-to-child transmission of these viruses and reducing the disease burden in newborns.A new study from researchers at Johns Hopkins University School of Medicine, supported by the US National Institutes of Health, found that HIV can persist in myeloid cells, a subset of white blood cells, in people who have been virally suppressed for years through antiretroviral therapy. The researchers emphasized that these findings challenge the long-held idea that these cells are short-lived, proving instead that these cells may contribute to an HIV reservoir and could be an important target in the development of a cure. Larger studies with more diverse participant pools will be needed to identify the proportion of people who show latent HIV in myeloid cells, as well as the mechanisms that replenish this reservoir over time.