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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.

The Global Health Technologies Coalition (GHTC) welcomes commitments by G7 nations to advancing health research and development (R&D) included in the G7 Apulia Leaders’ Communiqué. GHTC was pleased to see G7 leaders explicitly recommit to ending HIV/AIDS, tuberculosis, and malaria, in particular, through support for the Global Fund to Fight AIDS, Tuberculosis and Malaria, as well as neglected tropical diseases and polio as public health threats by 2030, and to countering the effects of climate change on infectious diseases. While it was encouraging to see this signal of political will at the highest level of government, it was disappointing that leaders fell short of offering new funding pledges or specific plans to realize these aims. We also welcome the expression of support by G7 leaders for the Pandemic Fund, which included a call for expanding the donor base and securing at least US$2 billion in new pledges and cofinancing. Given that the fund could prove a powerful new financial instrument for strengthening R&D and regulatory capacity in low- and middle-income countries, we hope that G7 leaders will follow through and provide new commitments as part of the fund’s replenishment this fall. On antimicrobial resistance (AMR), it was encouraging to see leaders vow to support public-private partnerships and implement push and pull incentives to accelerate the development of new antimicrobials and other tools to combat AMR. We also appreciate the G7 articulating support for an “ambitious” Political Declaration for the United Nations High-Level Meeting on AMR, with concrete targets and an evidence-based panel to drive action. We hope that in the coming months, new R&D targets will be included in the final text to complement the current high-level global targets outlined in the zero draft. While we applaud G7 leaders for voicing their continued support for research initiatives to confront emerging and enduring health threats, we now call on them to match their statements with follow-through and financial pledges to translate these commitments into reality. 

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.