Research Roundup: AI advancing drug development, malaria vaccine tested in large clinical trial, and first-in-human universal flu vaccine trial

The Trump administration’s budget request for fiscal year 2020 (FY20) includes cuts that—if enacted—would hamstring the research and development (R&D) of new global health technologies funded by the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), US Agency for International Development (USAID), and Department of Defense (DoD). Since the release of the budget request in early March, however, lawmakers from both parties have expressed their commitment to shielding these critical funding strings from the president’s scissors.Among the proposed cuts is a 12 percent reduction for NIH. On April 11, the Senate Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee (LHHS) held a hearing to review the budget request for NIH. From the beginning, it was clear the administration’s proposal would face bipartisan pushback. Subcommittee Chairman Roy Blunt (R-MO), in his opening remarks, said, “I'm disappointed, of course, that the 2020 budget request would cut the agency by 13 percent. I'm confident that this committee will not do that, but we'll talk to you today about the reasons that we should continue in the direction we're in rather than head in another way.”Chairman Blunt was followed by Ranking Member Patty Murray (D-WA), who delivered an even stronger rebuke: “At a time of remarkable possibility in medical research, a time where we can and should continue leading the world in medical discovery, the Trump administration wants to cut funding for NIH… President Trump's damage -- damaging budget is wildly out of step with the sentiments of Congress, thankfully, and the American people. And I feel confident, working with our Chairman, that we will once again reject it.”Later in the hearing, Senator Richard Shelby (R-AL), who serves as Chairman of the full Senate Appropriations Committee, also voiced his support for an NIH funding increase:“What you do is more important than most [of] what we do in America. I'm not interested in cutting your budget. I'm interested in increasing it…I think this is a great investment for America, for the world, for humanity, what you do… it's not only a financial investment, which is good for the economy. It is the leading scientists, the cutting edge of scientific research that you add. And we all benefit from it immensely.”The week prior, the House Appropriations LHHS Subcommittee had held their hearing on the NIH budget. Subcommittee Chairwoman Rosa DeLauro (D-CT) said that Congress would reject proposed funding cuts to the NIH. In her opening statement she emphasized the value of scientists’ work: "Funding [biomedical] research has the power to do more good for more people than almost anything else within the purview of this subcommittee.”Referring to the administration’s newly launched effort to end the transission of HIV and AIDS in the United States, Chairwoman DeLauro continued: “Decades of research supported by NIH led to the development of the very treatment and prevention approaches that have put achieving this goal within reach, specifically antiretroviral therapy and PrEP. The NIH must be involved, if we are to continue to make progress in reducing HIV and AIDS, domestically and abroad.”In other budget hearings, lawmakers focused on important funding sources for global health R&D outside of NIH—including the DoD. In the House Appropriations Defense Subcommittee hearing on the US Army budget on April 9, Rep. Betty McCollum (D-MN), Vice Chair of the Subcommittee and Co-chair of the House Global Health Caucus, pressed the Secretary of the Army and Army Chief of Staff about proposals to divert funding from malaria vaccine research funded by the US Army: “Given that malaria remains the number one infectious disease threat for troops deployed in these regions, and we know that we have issues with [treatment] compliance, whether it’s State Department, military, even Peace Corps volunteers because of the side of effects from these diseases, it remains critically important that the Army’s research on malaria vaccines continue. I’m concerned in the FY20 budget that the justification appears that the funding for the project that conducts malaria vaccine research is being realigned into other projects. Given nearly all the most effective widely-used anti-malarials were developed in part by the US military research team, I find the possibility of losing momentum in research extremely alarming.” With the ongoing outbreak in the Democratic Republic of the Congo (DRC), Ebola is another infectious disease high on lawmakers’ radar. On March 14, the Senate Appropriations LHHS Subcommittee held a hearing on the Ebola outbreak in DRC and other emerging health threats. Subcommittee Chairman Blunt’s (R-MO) opening statement emphasized, “It is clear that our investments to improve global health have a direct impact on the wellbeing of every American.” He highlighted recent funding increases he has championed for the NIH National Institute for Allergy and Infectious Diseases, the CDC, and the Global Health Security Agenda. Senator Richard Durbin (D-IL) also expressed his support for global health research: “If you wanted to look at the most important room in Washington, DC, when it comes to medical research over the last few years, it would be this room, this subcommittee. Under the leadership of Chairman Blunt and Senator Murray, we have seen for four straight years a 5 percent increase and real growth at the NIH. I think an overall 30 percent over that period of time, the 5 percent real growth each year. Increases to the CDC I wish were equal, but they had been good. We hope they'll get better in the future. I reject the President's budget out of hand. This notion of 12 percent cut to the NIH is just unacceptable and I think most Democrats and Republicans would agree.”In addition to defending investments in biomedical R&D, lawmakers have expressed support for funding for international aid and development—which would be cut by 24 percent under the President’s budget proposal. On February 27, the House Appropriations State and Foreign Operations Subcommittee held an oversight hearing on USAID Programs and Policies. In her opening statement, Appropriations Committee Chairwoman Nita Lowey (D-NY) emphasized the value of USAID, stating, “Failing to maintain our position as the leader in global development and humanitarian assistance will cost lives, risk the spread of infectious diseases, and reduce American influence around the world.” Included in the budget proposal is a US$1.35 billion reduction to the President’s Emergency Plan for AIDS Relief (PEPFAR). In response, several lawmakers vigorously defended the United States’ role in addressing the international HIV and AIDS epidemic. On March 6, Rep. Eliot Engel (D-NY), Chairman of the House Foreign Affairs Committee, said, “I'm particularly opposed to cuts in funding for global AIDS programs. There's a 22 percent cut in PEPFAR used to treat millions internationally, mostly in Africa.” Later that month, Rep. Karen Bass (D-CA) also defended PEPFAR: “The administration has maintained most Africa focused aid initiatives launched by previous Congresses, and in some cases have sought to fund them, however at far lower levels. These include the global President's Emergency Plan for AIDS or PEPFAR…and I'm glad that those initiatives have continued but concerned about the cuts in funding. I will conclude by stressing…that US relations with Africa has always enjoyed bipartisan support here in Congress, and we expect to continue to work together. Each time the administration has sought to reduce funding, the State Department or USAID, especially those that would impact African countries, we have worked together in a bipartisan manner to restore that funding.”In early April, Rep. Eliot Engel (D-NY) again affirmed his belief “in development as a way to advance American interest and security that’s rooted firmly in our values.” In reaction to the President’s budget proposal, he noted that, “Tuberculosis and malaria and AIDS patients all around the world” would be pushed aside by the “heartless and harmful approach to foreign policy.” The Trump administration’s budget request, if enacted, would slash funding for lifesaving research, development, and implementation of new global health technologies. Fortunately, lawmakers, with support from advocates, have diligently opposed these cuts. It’s our job to ensure this continues.

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 World Health Organization committee of experts who met on Friday to discuss the recent escalation of the Ebola outbreak in the Democratic Republic of Congo (DRC) decided against declaring it a public health emergency of international concern. The response to this outbreak, which has persisted for more than eight months and has killed more than 751 people, has been complicated by conflict, political instability, and distrust of Ebola services in the DRC. An experimental vaccine is being administered to known contacts of Ebola patients, as well as contacts of contacts and frontline workers, through a ring vaccination approach; yet, this remains a resource-intensive task that relies on the ability to quickly trace all contacts at risk and community trust in order to be effective. Commenting on why the committee decided against declaring this outbreak a global health crisis, Professor Robert Steffen, chairman of the committee, stated, “Although there was great concern about rising number [of cases] in some regions, the outbreak has not spread internationally,” but also added that efforts to contain the crisis should be redoubled. Other experimental therapies—a second vaccine and a post-exposure prophylaxis treatment—are also under consideration to help combat the epidemic. While the HIV virus is detectable in blood, once it enters human cells, the virus can remain hidden and out of reach of the immune system. However, a new study’s findings suggest that scientists may have discovered a way to reveal the presence of HIV in human cells. Scientists have identified a new shape of an essential HIV protein, dubbed State 2A, that allows the virus to gain entry into cells by interacting with a receptor on the cells, known as CD4, and two types of antibodies. Previously, scientists knew about three shapes, or conformations, that the protein uses to force its way into human cells. However, this fourth shape is one that the virus doesn’t usually adopt but allows it to elude the immune system. Forcing the protein, known as the envelope, in this new shape may reveal vulnerabilities within the virus to make it visible to the immune system, opening up a new potential strategy to enhance the effectiveness of treatment. Forbes interviewed Dr. Curt LaBelle, Managing Partner of the Global Health Investment Fund (GHIF)—a social impact investment fund initially structured and backed by the Bill and Melinda Gates Foundation (Gates Foundation) and JP Morgan in 2012. Focused on achieving a “double bottom line” of improving health outcomes and securing financial returns, the fund targets US$5-15 million investments in innovative global health companies that develop products that can be used in resource-limited settings. Now backed by other organizations such as GSK, Merck, and Grand Challenges Canada, among others, GHIF has advanced numerous technologies including a low-cost cataract surgery tool, a new oral cholera vaccine, and a river blindness treatment. This interview highlights the fund’s investment methodology and process, recent and successful investments, and how the fund manages the social impact of its investments, among other topics.