Breakthroughs Blog: 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, Gilead Sciences shared results from a late-stage study showing that its long-acting injectable HIV prevention drug, lenacapavir, was more effective at preventing HIV infection in cisgender women and adolescent girls compared to the company’s daily pill, Truvada. The study, which included more than 5,300 cisgender women and adolescent girls, was stopped early by an independent committee because the results exceeded efficacy expectations, with no incidences of HIV infection among participants who received the drug compared to those who were not on any prevention regimen. Truvada is already in wide use for both HIV treatment and prevention, but the twice-a-year lenacapavir injection, which could be approved for HIV prevention regimens by the end of next year, offers an option that could be much easier to adhere to than the daily pill for many people, especially higher-risk individuals.In Paris last week, as part of the replenishment launch for Gavi, the Vaccine Alliance, the African Vaccine Manufacturing Accelerator was launched, a project Gavi will invest $1 billion into over the next decade to help increase Africa’s vaccine manufacturing base to accelerate the rollout of vaccines and improve pandemic preparedness on the continent. This project follows glaring inequities in access to COVID-19 technologies faced by African countries during the pandemic. Specifically, Gavi will provide financial incentives to African vaccine manufacturers once they hit supply and regulatory milestones, using market forces to drive down prices and encourage upstream investment. The project set the goal for Africa countries to produce 60 percent of the vaccines used by the continent by 2040, up from 2 percent currently. It will also explore issues including technology transfer and regulatory harmonization.Elion Therapeutics recently announced the close of an $81 million funding round to advance the development of its next-generation polyene antifungal candidate, SF001, designed to reduce toxicity and address critical challenges associated with currently available antifungal options. The news comes as growing resistance to existing antifungals and increasing fungal infection rates highlight the need for new and improved tools. The promising compound received Qualified Infectious Disease Product and Fast Track designations in 2023 from the US Food and Drug Administration for early antifungal therapy of presumed invasive fungal infection and treatment of invasive aspergillosis. The funding round includes investments from the public-private partnership AMR Action Fund, the fund’s first investment in an antifungal company.

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. Last Tuesday, Valneva announced the launch of a Phase 1 clinical trial to investigate the safety and immunogenicity of a vaccine against the Zika virus, for which there are currently no available preventable vaccines or treatments. The second-generation adjuvanted inactivated vaccine candidate, VLA1601, will be tested in 150 adult participants in the United States, with the first topline data from the trial expected as soon as early next year.  Numerous outbreaks of Zika have occurred around the world, but the virus is currently circulating in Mexico, Central and South America, the Caribbean region, and some areas of the continental United States.Moderna’s next-generation mRNA vaccine for COVID-19 elicited a higher immune response against most strains of omicron BA.4/BA.5 and the original virus than the company’s currently licensed vaccine and has a similar safety profile in Phase 3 trial. The vaccine candidate, mRNA-1283, demonstrated the highest benefits in patients over 65, who are at risk of more severe disease. The trial included over 11,000 patients from across the United States, the United Kingdom, and Canada. These results also point to the future promise of the company’s combination mRNA vaccines for COVID-19 and influenza, which are also currently in development and previously demonstrated a similar immune response to the company’s vaccines for COVID-19.The US Food and Drug Administration (FDA) recently announced the approval of Roche’s Cobas malaria test for screening blood, organ, and tissue donors, which could help reduce the risk of transfusion-transmitted malaria. The test is designed to qualitatively detect in whole-blood samples Plasmodium DNA and RNA from the five main species of Plasmodium parasite species known to cause human infection: P. falciparum, P. malariae, P. vivax, P. ovale, and P. knowlesi. Roche’s technology is now the first FDA-licensed test for screening blood donors for malaria.