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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.Solidarity, a global clinical trial led by the World Health Organization, will resume its efforts, testing three new treatments among hospitalized COVID-19 patients: artesunate, an antimalaria; infliximab, an antibody used to treat autoimmune disease; and imatinib, a cancer drug. The original Solidarity trial, which took place across dozens of countries simultaneously in 2020, found that none of the four treatments it tested showed benefit. While the original trial included antivirals, this new phase will focus on drugs that target the body’s immune response, rather than the virus itself, given the two drugs that have shown success in reducing mortality in hospitalized patients, dexamethasone and tocilizumbab, work by dampening patients’ immune reactions. Medicines have shipped to Finland as the first country to begin the trial with 40 more countries in the process of seeking ethical and regulatory approvals to join.Use of the monoclonal antibody therapy REGEN-COV reduced the risk of developing symptomatic COVID-19 infection by 81 percent in those exposed to an infected patient, according to a study published last week in the New England Journal of Medicine. The study, which included individuals over 12 who had a household member test positive within the prior 96 hours, found that by day 28, 1.5 percent of participants who received the therapy developed symptomatic infection compared to 7.8 percent who received the placebo. When including asymptomatic infections, risk reduction from the treatment was 66.4 percent. The study also found that patients who did become infected after receiving the therapy were more likely to have milder disease. These findings were used to support a decision late last month by the US Food and Drug Administration (FDA) to expand emergency use authorization for REGEN-COV to be used as a post-exposure prophylaxis among high-risk populations.Valneva shared positive results last week from the phase 3 trial of its single-dose vaccine against chikungunya, which found that 98.5 percent of participants saw protective antibody concentrations 28 days after receiving the shot. This protection rate exceeds the 70 percent threshold set by the FDA. The trial also found that the VLA1553 vaccine was generally well-tolerated and induced a high immune response among elderly trial participants. The trial will continue with outcomes evaluated until month six. VLA153 is currently the only chikungunya vaccine in phase 3 trials that targets long-term protection from a single-dose, according to its developer. The company signed an agreement earlier this year with the Instituto Butantan in Brazil for development, manufacturing, and marketing, with the goal of making the product more accessible in low- and middle-income countries.

GHTC submitted the following statement, in accompaniment with a verbal statement, to the National Institutes of Health regarding a listening session on the proposed Advanced Research Projects Agency for Health. A recording of the listening session is available here.The Global Health Technologies Coalition (GHTC) is pleased to submit the following input to accompany our verbal input on the proposed Advanced Research Projects Agency for Health (ARPA-H) during the NIH-OSTP Listening Session 8. GHTC is a coalition of 38 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people. We are eager to share the perspective of our coalition on this exciting proposal for a new entity to develop breakthrough health technologies and platforms.If ARPA-H is created, GHTC strongly believes the initiative must be additive, with NIH leadership taking care not to uproot funding or technical expertise from any NIH institutes and centers and other US agencies advancing R&D.GHTC believes there is a strong case for ARPA-H to focus on poverty-related and neglected diseases (PRNDs), such as HIV/AIDS, tuberculosis, malaria, neglected tropical diseases, and antimicrobial resistance—a health area that with more support and collaboration is ripe for transformation. If the goal for ARPA-H is to produce transformative innovation where there otherwise would be none, few areas offer as much potential for R&D impact as PRNDs, for three main reasons:First, as afflictions associated with conditions of poverty globally, including in the United States, PRNDs offer little commercial incentive for the private sector to develop medical products to diagnose, treat, or prevent them. This market failure has led to historic under investment relative to the societal burden that these diseases produce. In 2016, the global private pharmaceutical sector spent approximately $159.9 billion on R&D for health overall, but only $511 million—less than one-third of one percent—on R&D for neglected diseases. In contrast, the private sector is investing heavily in R&D on treatments for cancer and Alzheimer’s disease. According to the Congressional Budget Office, in 2018, there were more than twice as many ongoing clinical trials for cancer and nervous system disorders (such as Alzheimer’s) than the next three biggest disease classes combined. While more resources are needed for R&D in many health areas that affect American and global health, leveraging the unique capabilities of the proposed ARPA-H model for PRNDs creates an opportunity to make a major impact in eliminating or even completely eradicating some diseases that are unlikely to be a focus of other stakeholders.Second, even though past US investments from different R&D agencies have produced laudable scientific advances against some PRNDs, a considerable number of high-impact innovation gaps remain: the world still awaits a vaccine and cure for HIV/AIDS, a single-dose cure for the deadliest form of malaria, shorter tuberculosis treatment regimens, better diagnostics for neglected tropical diseases, highly effective vaccines for tuberculosis and malaria, and many other innovations that could transform global health. Defeating these global health challenges remains a lofty goal, but as with COVID-19 in the United States, the right mix of resources and ingenuity—including through game-changing initiatives like ARPA-H—could create bridges to a healthier future for all.Third, if the goal of ARPA-H, like DARPA, is to foster transformative, sector-defining breakthroughs, then policymakers should note that investments in infectious disease research have historically paid dividends across the health R&D landscape. For instance, investments in HIV/AIDS research led to the immunological breakthroughs critical to understanding the pathogenesis of COVID-19. Research on malaria has produced anti-malarial drugs that are being evaluated as promising anti-cancer treatments. And a one-hundred-year-old tuberculosis vaccine is now being evaluated for its potential therapeutic and protective effects against Type 1 Diabetes, Alzheimer’s, and other diseases. In short, investments in infectious disease research have historically nourished a rich soil of scientific knowledge from which innovations for other disease areas have blossomed. It is clear that investing in PRND R&D through ARPA-H would yield a harvest of health advancements across the entire landscape of pressing needs.GHTC supports an ARPA-H framework that closely mirrors that of DARPA. This framework should include policies that would give APRA-H program managers maximum flexibility in how they distribute funding—enabling them to place high-risk, high-reward bets with strategic partners. For instance, if freed from the burdens of the typical NIH funding process, ARPA-H program managers could more easily collaborate with product development partnerships (PDPs)—partnerships that combine expertise, resources, and funding from the public, philanthropic, and private sectors to create products that address specific public health goals. With flexible funding capacities, ARPA-H program managers could leverage PDPs and other aligned partners as a powerful tool for solving the most difficult public health challenges.We understand that designing ARPA-H will require a thoughtful negotiation between oversight and the flexibility necessary to foster innovation, as well as a thoughtful balance among many competing disease priorities rising to the fore based on public health need, scientific neglect, ripeness for breakthroughs, and other factors. We believe that a focus on PRNDs—an area of historic market failures—holds the greatest potential for ARPA-H’s societal impact and that flexible funding capacities designed to foster partnership are essential for its success. We stand ready to work with you on the design of this exciting initiative.

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 Monday, the COVAX vaccine-sharing facility and the World Bank launched a new financing mechanism to increase access to COVID-19 vaccines in low- and middle-income countries. The scheme builds on the existing COVAX advance market commitment (AMC) mechanism by allowing AMC-eligible countries to make additional advance purchases through COVAX—beyond the fully donor-subsidized doses AMC-eligible countries are already receiving—based on aggregate demand across countries, using financing from the World Bank. The new plan will also provide participating countries with greater transparency on vaccine availability, prices, and delivery schedules, enabling them to implement vaccination plans more effectively. COVAX has so far delivered around 150 million doses to 137 countries and aims to deliver 2 billion doses by the end of this year, in addition to 1.8 billion next year.BioNTech intends to begin clinical trials for a “safe and highly effective malaria vaccine,” based on the mRNA technology behind its COVID-19 vaccine, by the end of next year, the company announced last week. Developing a vaccine able to induce a strong, long-lasting antibody response against malaria is difficult, as the genome of the parasite that causes malaria is more complex than viruses, according to researchers—however, insights from developing an mRNA-based vaccine against COVID-19, combined with a growing understanding of how malaria works, could make this an optimal time to address the challenge, a BioNTech representative said. BioNTech is also looking to establish an mRNA vaccine production facility in Africa, bolstering manufacturing capabilities on the continent and ultimately producing various mRNA-based vaccines beyond COVID-19.Researchers were able to wipe out a population of malaria-transmitting mosquitoes using a genetic engineering method that renders females infertile, according to study results published Wednesday. The gene-drive technology aims to bypass natural selection by plugging in a set of genetic instructions that rapidly spread through a population and pass on an infertility trait—far faster than could be achieved through conventional selective breeding. The new study tested whether gene drive of a sex determination gene—which has been previously tested, successfully, in a smaller trial—would spread and cause the same population collapse in closer to real-world conditions. Researchers plan to continue with more comprehensive gene-drive testing and environmental risk assessments before moving to larger field trials. The self-sustaining and fast-acting technology is meant to work alongside existing tools, such as bednets, insecticides, and vaccines.