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. On Friday, the World Health Organization (WHO) published a new report detailing the antibacterial agents, including antibiotics, in clinical and preclinical development worldwide, finding that despite improvements, the pipeline remains inadequate to confront the urgent need for new, innovative technologies to address serious infections and replace those becoming ineffective due to rising antimicrobial resistance. According to the report, new products are not being developed at the pace and scale needed to ensure new antibiotics are delivered, given the time required for products to move through the pipeline and the likelihood of failure. Specifically, the report identified gaps in agents for children, agents with more convenient oral formulations, and agents that can address drug-resistant pathogens. The report also stressed that efforts to boost innovation must accompany parallel efforts to ensure equitable access to existing and new products, particularly in low- and middle-income countries, where access gaps can hasten the rise of drug resistance.  Last week, the Global Antibiotic Research & Development Partnership (GARDP) announced an agreement with Bugworks Research to support the further development of a new broad-spectrum antibiotic that targets some of the most difficult-to-treat bacterial pathogens, aiming to enable access simultaneously in Western countries and low- and middle-income countries with a high burden of antimicrobial resistance. GARDP will provide Bugworks up to $20 million in financial and technical support through the approval and commercialization of BWC0977, a compound that has demonstrated in-vitro activity against WHO critical priority pathogens, in return for the manufacturing and commercialization rights to it in 146 primarily low- and middle-income countries. Bugworks previously received more than $12 million from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, for the preclinical development and Phase 1 study of the compound. Moderna recently announced positive late-stage trial results for mRNA-1083, its COVID-flu combination vaccine. The company is the first of several testing a combined COVID-flu vaccine to announce positive late-stage trial results, as experts raise calls for new tools to ensure more people have better protection against both viruses. Trial participants who received the vaccine showed an improved immune response compared with those who got the standalone flu and COVID vaccines that are currently available, even for people 65 years and older, who generally do not mount as robust immune responses to vaccines compared to younger people. The company hopes to have the vaccine approved for the fall of 2025.

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, US Food and Drug Administration advisers recommended that next fall’s updated COVID-19 vaccine target the lineage of the JN.1 variant, which became dominant in the United States last winter. There was some debate among experts on whether the vaccine should target the KP.2 subtype of the variant that is now most common in the United States or other offshoot subtypes that may become more dominant over the summer, ultimately deciding to target JN.1 itself, with the hope that the vaccine would offer some cross-protection against other subvariants that might emerge. Moderna, Pfizer, and Novavax say they could have JN.1.-specific shots ready by the fall.Two clinical trials have been launched to test a new, long-acting form of HIV pre-exposure prophylaxis, or PrEP, in cisgender women and people who inject drugs, two populations that have been largely underrepresented in HIV clinical trials. The mid-stage studies, sponsored and funded by Gilead and implemented through the HIV Prevention Trials Network, will test lenacapavir, an injectable antiretroviral drug administered every six months, which is already approved by the US Food and Drug Administration for HIV treatment in combination with other antiretroviral therapy for heavily treatment-experienced individuals and is the first in the capsid inhibitors class of drugs to be FDA approved for HIV treatment. The researchers hope these studies will provide critical data on the use of lenacapavir as HIV PrEP.Last week, the Sabin Vaccine Institute announced a new research project with the Kenya Medical Research Institute aimed at optimizing the use of the oral cholera vaccine in the face of a global resurgence in cholera and acute vaccine shortages, hopefully improving the impact of the vaccine and saving lives. The shortage of the oral cholera vaccine in 2022 led the World Health Organization (WHO) to temporarily modify the two-dose vaccine regimen and recommend a single dose during outbreaks, underscoring the urgent need for research to optimize vaccine use. WHO currently recommends two doses of oral cholera vaccine two weeks apart. The new research will test strategies to extend the time between doses to ensure that more people can receive protection.

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. A new study successfully stimulated animals’ immune systems to induce a rare, priority class of HIV broadly neutralizing antibodies (bNAbs), findings that the researchers hope could eventually lead to an HIV vaccine that generates multiple classes of bNAbs to prevent HIV. The researchers engineered immunogens, or molecules used in vaccines to elicit a specific immune response, and tested them in monkeys and mice to see if they induced antibodies that showed signs of maturing into the class of HIV bnABs that is a priority for HIV vaccine development because it neutralizes a broad range of HIV variants. bnAbs are seen as an especially promising strategy for HIV vaccine development because they bind to parts of the genetically diverse virus that stay constant even as it mutates. These findings support the potential of these immunogens as the first part of a multistep vaccine regimen for humans.The Coalition for Epidemic Preparedness Innovations (CEPI) has awarded $6.5 million to support phase 2 clinical trials of Bavarian Nordic’s MVA-BN mpox vaccine for children in Africa, as the disease has spread rapidly in recent years and has particularly affected children, who account for most of the infections and deaths in the current outbreaks in East and Central Africa. The study, which is expected to launch later this year in one or more African countries, will enroll 460 people in endemic regions who do not have a history of mpox illness or vaccination. This trial also complements a plan by African countries, announced in April, to coordinate mpox efforts.Last week, the Ministry of Health of Indonesia and the Medicines Patent Pool (MPP) announced that they have signed a Memorandum of Understanding to improve access to and uptake of vaccines and medicines in Indonesia, as well as to strengthen local production in the country. MPP will provide technical assistance on local manufacturing by identifying possible manufacturing partners, exploring opportunities for technology transfer, and working with manufacturers to strengthen their capacity to produce high-quality, affordable products and new technologies, including mRNA vaccines. The partnership will also support the introduction of innovative medicines that address current access gaps and needs, health workforce capacity-strengthening, and support for the licensing and uptake of products licensed by MPP.

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. In a new study, researchers from the Baylor College of Medicine and partner institutions found that a novel, nonhormonal sperm-specific approach showed promise in mice as a reversible male contraception option. The researchers identified a small molecule that would inhibit a key protein, STK33, required for fertility in both mice and human males and generated modified versions of STK33 inhibitors to make them more stable, potent, and selective, eventually testing the most effective compound they generated in mice. The researchers hope to further evaluate the inhibitor and similar compounds to determine effectiveness as a potential contraception option. There has been research into a variety of different strategies for male contraception, but there are currently no approved options for men beyond male condoms.Tens of thousands of genetically modified mosquitoes have been released in Djibouti to stop the spread of Anopheles stephensi mosquitoes that transmit malaria as part of the pilot phase of a partnership between Oxitec, the government of Djibouti, and Association Mutualis. The modified mosquitoes carry a gene that kills female offspring, the only mosquitoes that bite and transmit malaria, before they can reach maturity. If successful, the modified mosquitoes will be tested in larger field trials, and operational deployment will continue through next year, hopefully boosting malaria control efforts. This partnership is the first time that modified mosquitoes have been released in East Africa and the second time on the African continent, although similar technology has been successfully used in Brazil, the Cayman Islands, Panama, and India, with more than one million modified mosquitoes released around the world since 2019.The Administration for Strategic Preparedness and Response at the US Department of Health and Human Services is moving forward with a plan to produce 4.8 million doses of H5N1 avian flu vaccine, as the current outbreak's second human case in the United States was identified this week. The two vaccine candidates are currently in bulk form, with one of the two candidate vaccine viruses reportedly well-matched to the currently circulating strain. Health officials have identified a manufacturing line at one of its manufacturing partners for fill-and-finish, which will take a couple of months to complete. Agency officials are also coordinating with mRNA vaccine makers Pfizer and Moderna about their potential involvement in vaccine development. There are additional ongoing interagency discussions about what would trigger vaccine deployment, including a change in transmission propensity, like human-to-human or animal-to-human spread; any sign of increased illness severity; a change in the complexion of the cases, like a human infection with no tie to the affected dairy farms; or the identification of a mutation in the virus.