Research Roundup: Rapid diagnostic licensing deal, Pan-flavivirus vaccine project, New sleeping sickness & river blindness drugs

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. Two new reports from the AMR Industry Alliance, a coalition of companies and trade unions in industries working to combat antimicrobial resistance (AMR), highlight both progress and setbacks in the field of antimicrobial resistance research and antibiotic development, as the threat of AMR rises globally. A survey of members demonstrated positive findings, including many industry members having implemented measures to support antimicrobial stewardship and efforts to increase antibiotic access in lower-resource countries, as well as having invested in AMR-relevant R&D. On the other hand, there has been a decline in AMR researchers over the last few decades, leading to less published research on AMR and fewer patents on new antibiotics, the decline particularly acute when compared to cancer and HIV/AIDS. The findings highlight the need for government and private sector incentives to provide adequate funding and investment for AMR research and novel antibiotic development, as well as for efforts to introduce young scientists to the field.The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) recently announced $1.8 million in funding to biotechnology company Visby Medical to develop a portable rapid diagnostic test that detects Neisseria gonorrhoeae, the pathogen that causes gonorrhea, as well as its susceptibility to ciprofloxacin, an oral antibiotic that was formerly a go-to treatment, which can no longer treat resistant forms of the pathogen. The test would allow health care providers to rapidly test and refer patients to the right treatment while hopefully ensuring that ceftriaxone, the only remaining effective antibiotic against resistant N. gonorrhea, is properly managed. The funding will also support the development of a test for N. gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis in men based on urine samples.The Coalition for Epidemic Preparedness Innovations (CEPI) will provide up to $2 million in funding to German biotech company LenioBio GmbH for a preclinical proof-of-concept for using its commercially available, plant-based, and cell-free technology to produce proteins for use in clinical trials testing vaccines against epidemic and pandemic threats in 20 to 40 days. If proven successful, this approach could greatly reduce the time it traditionally takes to manufacture vaccine proteins using other methods, which would be a major boon to CEPI’s 100 Days Mission to develop vaccines against novel pathogens with pandemic potential within 100 days of identification. The easy-to-use technology could also be rolled out for use in remote or low-resource settings, allowing greater availability of and access to future vaccines in those settings. 

2024 will be a pivotal year for global health. With a record number of national elections, including one in the United States, many multiyear global health architecture reform processes are set to come to a close, and with several major replenishment and resource mobilization campaigns taking place, there is a palpable sense of “now or never” permeating global health discussions.  The World Health Organization (WHO) Executive Board (EB) meeting, which serves as the kickoff to the multilateral calendar, served as the first test on whether stakeholders could come together to ensure that progress continues. While the week offered welcome moments of political support for research and development (R&D), there is a sense that leaders have not yet met the moment to get the world back on track toward achieving the Sustainable Development Goals (SDGs).  Here are some key reflections from a busy week in Geneva:  Deadline looms over pandemic accord and International Health Regulations processes  As in previous years, the WHO’s role in global health emergencies was a central topic at the EB. Just weeks before the fourth anniversary of the COVID-19 pandemic, delegates received a new update from WHO on strengthening the global architecture for Health Emergency Prevention, Preparedness, Response and Resilience, which focused on the need for sustained political leadership and financing to drive the reform agenda forward. And while not on the official EB agenda, the work of amending the International Health Regulations (IHR) and finalizing a pandemic accord also loomed large. Little of the debate focused on specific proposals of these deliberations, though advancing access to medical countermeasures, vaccine equity, and regionally distributed manufacturing all got mentioned during these sessions. Instead, member states zeroed in on the process itself, with delegates seeking to inject a new sense of urgency to finalizing deliberations and adhering to the May deadline. Despite this, Poland became the first country to publicly question the feasibility of the current timeline, calling for a possible extension, signaling that there is also trepidation around how much progress can be achieved with limited negotiation days. The sessions on health emergencies also became the platform for geopolitical proxy battles, with the Russia and Ukraine and Israel and Palestine conflicts spilling over into the global health security debates. Several heated exchanges nearly derailed proceedings, and much airtime was spent addressing grievances.Tuberculosis, immunization, and neglected tropical disease reports highlight setbacksMultiple sessions during the week highlighted the continued disruption in healthcare caused by the pandemic. Despite reaching the midpoint in implementation of the SDGs, global progress remains off track in many key areas. This includes the fight against tuberculosis and neglected tropical diseases, which the WHO highlighted as requiring a renewed focus from member states.  The importance of investing in local production, strengthening laboratory capacity, and ensuring new tools are better adapted to the communities they are meant to serve were all key themes that came out of these sessions.Routine immunization levels are also still lagging behind pre-pandemic rates, with uneven progress regionally.  In its report to the EB, the WHO has documented that the current progress is not enough to meet targets set in the WHO’s Immunization Agenda for 2030. Low- and middle-income countries spoke of the cost of vaccinations as a major financial burden and challenge.  Yet there were notes of optimism too: 2024 is also expected to be a major year for immunization, with the rollout of two new malaria vaccines and two new polio vaccines, bringing the world closer to eradicating some of the planet’s deadliest diseases. Antimicrobial resistance shifts into bigger focus With the UN High Level Meeting on Antimicrobic Resistance (AMR) scheduled later this year and the WHO’s global action plan on AMR coming to an end in 2025, AMR was expected to be a prominent topic at this year’s meeting. While it made its way back on to the official agenda, it unfortunately did not receive as much attention as anticipated, with the agenda item being pushed late into the evening on Friday.  Member states ultimately advanced a resolution sponsored by Thailand which calls on member states to support R&D for new tools to combat AMR, to strengthen the capacities and standards of laboratories, and to participate in the WHO’s Global Antimicrobial Resistance and Use Surveillance System (GLASS), though several countries also wished to discuss the decision further ahead of the World Health Assembly (WHA) in May where it will be up for formal adoption. In his remarks on the topic, WHO Director-General Dr. Tedros Adhanom Ghebreyesus echoed the calls for stronger surveillance; the development of new vaccines, diagnostics, and antimicrobials; and measures to make these interventions accessible and affordable. New resource mobilization push for WHO  EB members supported the proposal for an investor round to raise funds for WHO, which would likely be held in November, with uncharacteristic enthusiasm last week. The WHO Working Group on Sustainable Financing’s report to the 2023 WHA highlighted that WHO’s budget is “up to 86% dependent on generous donors” and that only “roughly 14% of WHO’s finances are truly predictable”. The future effectiveness of WHO will depend on changing how the agency is funded. Progress has been made to increase the percentage of assessed contributions received in the form of member state dues, but far more flexibility and predictability in voluntary contributions will be needed to meet this moment. The idea of a WHO investment round, similar to those hosted by the Global Fund and Gavi, the Vaccine Alliance was accepted in principle by last year’s WHA. Dr. Tedros was charged by member states to provide a framework and justification at this year’s EB, and he delivered his investment case.  The investment framework is closely aligned with WHO’s 14th General Program of Work and the new strategic roadmap for the agency, but this WHO resource campaign will also have to compete with a number of replenishments set for this year, including for Gavi, as well as a resource push for the World Bank Pandemic Fund. This year feels like a make-or-break moment for the SDGs and the 2030 agenda. Yet the EB felt too much like business as usual, with ambition getting bogged down in a bloated agenda, geopolitical battles, and the minutia of internal processes. The urgency highlighted by several delegates on EB topics was not matched in the action or the commitments countries made in Geneva last week. While the EB did not jeopardize the potential of many processes moving forward, it did too little to contribute to the necessary forward momentum we will need to achieve the ambitious agenda set out by global leaders.