Hannah Sachs-Wetstone

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 Global Antibiotic Research and Development Partnership (GARDP) and Bugworks announced an agreement to accelerate the development of a broad-spectrum antibiotic compound, BWC0977, which has shown potential in treating patients with serious infections caused by pathogens that have become increasingly hard to treat due to growing antibiotic resistance to multiple classes of drugs. GARDP has agreed to invest up to $20 million for further clinical and pharmaceutical development. If the antibiotic is ultimately approved, Bugworks plans to launch it in the United States, the European Union, Japan, and China, while GARDP will manufacture and commercialize the compound in 148 countries, including nearly all low- and middle-income countries, with both partners emphasizing their hope to ensure rapid access and appropriate use in high-burden countries like India and South Africa, where access to novel antibiotics is often limited. Promising results from a phase 2a trial of a broad-spectrum influenza vaccine candidate were published in The Lancet Infectious Diseases last week. The trial, which tested the biopharmaceutical company Osivax’s candidate vaccine OVX836 at various doses in 137 healthy adult subjects, found that it was safe and immunogenic at all dose levels tested, warranting further testing in larger phase 2b and 3 trials. The vaccine, which fits the universal influenza target product profile set by the US National Institutes of Health, could be a promising new tool to address influenza if further tests continue to confirm its potential.New research found that a novel mRNA-based malaria vaccine, which takes a unique approach by using an ingredient developed to boost the immune response to cancer, was effective in mouse models. The novel vaccine generated an immune response in mouse models, prevented infection with one form of the Plasmodium parasite, and unlike many other malaria vaccines, proved effective in animals that had already been exposed to malaria, underscoring the potential of this tool in malaria-endemic regions. While this research is still in very early stages, scientists plan to next test the vaccine in humanized mouse models and hope to be able to advance to clinical trials in the coming years.

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 month, Brazil became the first country in the world to introduce tafenoquine, the first new single-dose treatment for P. vivax malaria developed in 70 years. Tafenoquine, developed by GSK and Medicines for Malaria Venture (MMV) in partnership with local researchers in Brazil, improves upon the previous treatments, which had major issues with adherence due to higher complexity and longer duration. The local Brazilian research partners also developed a new point-of-care test to identify a hereditary condition that can cause hemolytic anemia in those who take tafenoquine or one of the previous treatments, primaquine. After the approval and registration of tafenoquine in Brazil in 2019, field studies conducted over the last few years found extremely high levels of compliance with the new treatment protocol of routine testing to inform treatment, and similar feasibility studies are starting around the world, which will hopefully provide further evidence to improve global and national malaria guidelines and programs.The world’s first trial for a potential treatment for Crimean-Congo hemorrhagic fever has launched in Turkey. There are currently no specific approved drugs or vaccines and limited funding for R&D for the virus, which was named a priority pathogen by the World Health Organization. It is endemic in many countries in Africa, the Middle East, and Asia and has a mortality rate as high as 40 percent. The phase 1 trial will test the safety and potential dosages of two different drugs in multiple combinations, hopefully leading to more advanced trials or at least initiating momentum for more research to address the virus.This week, the US Food and Drug Administration approved a monoclonal antibody, Beyfortus, to protect infants and young children from respiratory syncytial virus (RSV). The single-injection antibody therapy, developed by AstraZeneca and marketed in the United States by Sanofi, showed strong results in phase 3 clinical trials. If the treatment gets a further recommendation from the Centers for Disease Control and Prevention, the drug could greatly reduce hospitalizations and deaths caused by RSV, which is the leading cause of hospitalization of babies in the United States. Beyfortus, has already been licensed in the European Union, the United Kingdom, and Canada, and other technologies for RSV, including a vaccine for pregnant people are also aiming to reduce the global burden of the virus.

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 World Health Organization (WHO) prequalified the first conjugate vaccine to protect against the five dominant causes of meningococcal meningitis in Africa. The vaccine, MenFive, which was developed through a collaboration between the Serum Institute of India Private Limited and PATH, with financial support from the UK’s Foreign, Commonwealth, and Development Office, demonstrated a high level of safety and immunogenicity in extensive clinical studies in The Gambia, India, and Mali. WHO’s prequalification will allow MenFive to be procured by United Nations agencies and Gavi, offering a promising tool that could avert the annual outbreaks and epidemics in the African countries with the most meningitis cases and deaths.A multisite phase 1 HIV vaccine clinical trial carried out by the Globally Relevant AIDS Vaccine Europe-Africa Trials Partnership concluded with preliminary analysis demonstrating strong results. The novel mosaic HIV vaccine candidate, HIVconsvX, demonstrated the ability to trigger a strong and specific immune response that targets a broad range of HIV-1 variants, making it potentially applicable for HIV strains around the world. Researchers say it also represents an innovative approach within a pipeline of vaccine candidates that needs to be diverse to maximize the chances of success. The full reporting of the primary findings from the trial is expected later this year followed by further in-depth analysis.Last week, a joint statement from the United Nations Food and Agriculture Organization, WHO, and the World Organization for Animal Health warned that the H5N1 avian flu virus could adapt to more easily infect humans and urged multisector, international partnership and cooperation to protect both animal and human populations. The current H5N1 clade 2.3.4.4b has been circulating since 2020, causing unprecedented deaths around the world across different animal populations, especially in wild birds and increasingly, mammals. Although human cases have been only sporadic, maintaining and strengthening surveillance capability to be able to detect viral changes and human cases, as well as testing the currently circulating viruses for resistance to available antiviral drugs, will be essential to avoid further devastation.

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. Gavi, the World Health Organization (WHO), and UNICEF have announced that an initial 18 million doses of the world’s first malaria vaccine, RTS,S/AS01, will be rolled out in 12 African countries, where the risk of child illness and deaths from malaria is highest. The vaccine, which will be produced by GlaxoSmithKline and Bharat Biotech, is expected to arrive in the initial countries in late 2023. A further 16 countries have also asked for access and are expected to receive it once production has scaled up. Another malaria vaccine, R21, developed by Oxford University is currently awaiting WHO prequalification. In the coming years, both vaccines are expected to play a key role in the fight against malaria alongside other tools.A study published last week found that injections of broadly neutralizing antibodies in children living with HIV can improve the protective effects of antiretroviral drugs, marking the first time broadly neutralizing antibodies have been tested in combination with antiretroviral drugs in a pediatric population. The treatment suppressed cells that contained the virus and were capable of reactivating, paving the path to further research that could confirm the use of this method as a supplemental or alternative treatment for HIV in children. The publication of these findings follows recent research, which has focused on testing broadly neutralizing antibodies as a treatment for adults with HIV. Worldwide, about 1.7 million infants and children are living with HIV.Last week, Gavi confirmed that some of the $2.6 billion remaining in COVAX, the COVID-19 vaccine delivery initiative, could be redirected towards furthering investigational vaccine candidates for Marburg and Ebola Sudan, as well as a hexavalent vaccine that would offer protection against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and the inactivated polio vaccine. The investments for Marburg and Ebola Sudan will hopefully contribute to ensuring clinical trials in future outbreaks, especially after the scrapped trials during the recent Marburg and Ebola Sudan outbreaks.

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 Bill & Melinda Gates Foundation and Wellcome Trust announced that they will jointly invest more than $500 million in phase 3 trials for the GSK-developed M72/AS01E tuberculosis (TB) vaccine, which could become the first new tuberculosis vaccine in 100 years. 2018 phase 2b trials showed that the vaccine was 50 percent effective, but after GSK pulled out because they did not see a commercial market for the vaccine, the company passed the license to the Bill & Melinda Gates Medical Research Institute in 2020. The phase 3 trials will involve 26,000 people in Africa and Southeast Asia, hopefully confirming the vaccine’s viability as TB cases and deaths rise around the world.A new initiative led by Gavi, the World Health Organization, and the Coalition for Epidemic Preparedness Innovations will work to stockpile experimental vaccines for infectious diseases with epidemic potential to improve preparedness for future outbreaks. This global virtual pooled inventory will initially focus on Marburg and the Sudan strain of Ebola, for which there are no existing vaccines or proven treatments. Last year’s outbreaks in Africa of these two hemorrhagic fevers saw aborted attempts to move forward clinical trials for vaccines, losing crucial opportunities to gather essential data on potential tools and highlighting the need for this kind of stockpiling, preparation, and partnership.The Medicines Patent Pool recently announced sublicensing agreements with seven manufacturers to produce and distribute generic versions of Shionogi’s COVID-19 antiviral treatment in low- and middle-income countries, improving availability and equitable access in these countries, even after the end of the Public Health Emergency of International Concern. The oral antiviral, Ensitrelvir, is currently only approved in Japan, although it is being considered in the United States and all 117 countries in the agreements. Medicines Patent Pool previously signed sublicensing agreements with Pfizer in 2021 to manufacture and distribute its treatment, Paxlovid, in 95 low- and middle-income countries.

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 World Health Organization (WHO) published its first global research agenda outlining key priorities in the fight against antimicrobial resistance. The intent of the agenda is to provide researchers, policymakers, funders, and other stakeholders with priority research topics for which greater action and evidence is needed. It covers issues including preserving current antimicrobials, advancing point-of-care diagnostic tests, and developing novel drugs to treat drug-resistant infections. The 40 priorities that relate to prevention, diagnosis, treatment and care, and cross-cutting topics were developed after a review of more than 3,000 documents published over the past decade looking at antimicrobial resistance.A recent study found promising results for a new, point-of-care genomic test for human papillomavirus (HPV) that could be a cheaper and more accessible option for cervical cancer screening in low-resource areas like sub-Saharan Africa, which has the highest rate of deaths from cervical cancer globally. Unlike currently available screening options, the HPV DNA test can be performed by a health care professional with minimal training using a mini centrifuge in the lab, cutting out the need for robust laboratory infrastructure and highly skilled professionals. The research team behind the test is now trying to make the test even more effective and efficient in low-resource settings by making it faster, inclusive of more HPV genotypes, and more sensitive.Researchers from the University of Montreal recently published a study showing for the first time the crucial role of a protein, adyl hydrocarbon receptor, or AhR, in allowing HIV to remain latent in the body, thus requiring antiretroviral therapy to be maintained in order to keep the virus from replicating. The researchers used CRISPR technology and drugs to neutralize the activity of AhR and observed that viral growth occurred in people living with HIV and on antiretroviral therapy. The study proposes a “shock and kill” strategy that would use drugs to inhibit and then reactivate AhR in the presence of AhR inhibitors to expose the HIV-infected cells for the immune system to then target and kill. Investigators hope further research can validate this method of fighting HIV.