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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. The Population Council and its partners announced the launch of the first clinical trial to test the safety and efficacy of a male contraceptive gel—an innovation that could advance contraception and bring more equality to the burden of family planning, which is largely borne by women. The gel, known as NES/T, is a novel, reversible contraceptive composed of a progestin hormone used for female contraception and testosterone. The gel is designed to be applied daily and absorbed through the skin on the upper arms and shoulders. The phase 2b trial, sponsored by the National Institutes of Health, will test the product for pregnancy prevention among more than 400 couples. Should NES/T prove effective, it would be the first user-controlled method for contraception for men since the condom. Last Monday, South African drug maker Aspen Pharmacare launched a triple-antiretroviral (ARV) combination tablet for the treatment of HIV in South Africa—a country which accounts for 19 percent of the global burden of people living with HIV and 15 percent of new infections. The new medicine, known as Emdolten, is taken once daily and contains dolutegravir, an antiretroviral medication that counters the drug resistance that often develops with older HIV treatments, along with lamivudine and tenofovir disoproxil fumarate. In May, the South Africa Regulatory Authority and the European Medicines Agency issued a warning advising doctors not to prescribe dolutegravir to women seeking to becoming pregnant following cases of birth defects in a study; however, Aspen Pharmacare stated that using dolutegravir is safe for men, women not of child-bearing age, and child-bearing women using contraceptives, which account for approximately 70 percent of HIV patients. Researchers have developed a way to freeze-dry an inactivated poliovirus vaccine (IPV) so that it can be stored at elevated temperatures, up to 40°C, for four weeks and then dissolved for use without losing its potency—potentially offering a new tool to eradicate the disease. While existing oral vaccines have led to polio’s elimination in many countries, these oral vaccines contain a weakened live virus, which can cause paralysis in rare cases. Thus, there has been push to use IPVs, which contain dead strains of the virus. Although IPVs have already been introduced in many countries, their widespread use is inhibited by their sensitivity to temperatures above and below approximately 4°C (39.2°F).

The Global Health Technologies Coalition (GHTC) yesterday honored Senator Roy Blunt (R-MO) and Congresswoman Rosa DeLauro (D-CT) at its second annual Innovating for Impact Awards. GHTC also recognized the partnership that developed and introduced improved child-friendly tuberculosis (TB) medicines, making these transformative treatments available to children in need worldwide. This event, which celebrates US policymakers and partnerships driving progress in global health innovation, was hosted with support from Johnson & Johnson.In remarks at the event, Senator Blunt voiced his support for continued US efforts to find treatments and cures for the world’s deadliest diseases. “We’ve seen real crises in the last few years…Ebola in 2014…Zika in 2015—and suddenly the globe gets really small. Suddenly there are no borders or barriers in a global health crisis, and we’ve been reminded too often of that. You just simply can’t separate global health and American health,” said Blunt in accepting his award. Senator Blunt, who is Chairman of the Senate Labor, Health and Human Services Appropriations Subcommittee, received a Congressional Champion Award in recognition of his leadership in protecting and expanding funding for agencies engaged in global health research and development (R&D), including the National Institutes of Health and the Centers for Disease Control and Prevention.View video honoring Senator Roy Blunt.Congresswoman Rosa DeLauro, who is ranking member of the House Labor, Health and Human Services Appropriations Subcommittee, was also recognized with a Congressional Champion Award for her leadership in championing medical research funding and in galvanizing action and new funding to respond to the Ebola and Zika epidemics. Caitlin Peruccio, a member of Rep. DeLauro’s staff, accepted the award on behalf of the Congresswoman who was not able to attend due to House leadership elections yesterday evening. “The questions before us are not just about policy, they are about our values…We cannot ignore the suffering of those beyond our border or pretend their fortunes are somehow separate from our own. Global health must be an American priority,” Peruccio said, reading the Congresswoman’s prepared remarks.View video honoring Congresswoman Rosa DeLauro.GHTC presented the Partnership Award to Dr. Mel Spigelman, president and chief executive officer of TB Alliance, who accepted the award on behalf of the many partners who supported the development and roll out of improved TB medicines designed specifically for children. This partnership, which was led by TB Alliance—with contributions from Australian Aid, Irish Aid, Unitaid, the US Agency for International Development, UK Aid, and other partners—produced new formulations of TB treatments that are appropriately dosed for children, dissolvable in water, and fruit-flavored for palatability. Now available in 86 countries and counting, these affordable medicines have transformed the treatment of TB for children and their families around the world.“On behalf of TB Alliance and our partners, we are honored to receive this award. We are proud to have had the opportunity to improve the treatment landscape for children, who are perhaps the most vulnerable of those afflicted with TB. Our ultimate goal of ending the TB epidemic will require both new tools and collaborative approaches; we remain dedicated to advancing TB drug research, development and delivery with our partners worldwide, so we can one day realize a world in which every person with TB can be treated with an affordable, safe, short, and effective therapy,” said Dr. Spigelman.View video honoring child-friendly TB medicines.Dr. Spigelman was joined onstage by Cheri Vincent, Chief of the TB Division at the US Agency for International Development, and Dr. Anna Laura Ross, Technical Manager of Strategy at Unitaid, for a short dialogue discussing their organizations’ contributions to develop and bring these child-friendly TB treatments to market.Attendees also heard from Kojo Nnamdi, host of NPR WAMU's The Kojo Nnamdi Show, who emceed the dinner, and Dr. Alan Tennenberg, Chief Medical Officer of Global Public Health at Johnson & Johnson who spoke about the power of multisector partnerships in advancing global health innovation.“GHTC is thrilled to honor Senator Blunt, Congresswoman DeLauro, and the developers of child-friendly TB medicines with our Innovating for Impact Awards,” said Jamie Bay Nishi, director of GHTC. “US leadership in global health R&D has helped fuel tremendous progress in generating new cures and vaccines to fight the world’s deadliest diseases, and we’re so delighted to recognize the outstanding work of our honorees who helped make this progress possible.”Global health R&D is vital to conquering the world’s greatest health challenges and to building a safer, healthier world for all. Now in its second year, the Innovating for Impact Awards celebrates US commitment to global health R&D and honors the multisector partnerships and policymakers helping to transform breakthrough scientific research into lifesaving technologies for unmet global health challenges. 

Malaria has infected humans for a very long time and in more places than many realize. There’s evidence that 3,000 years ago, malaria killed King Tut. It stalked the marshlands and fens of Great Britain and was common in the American South until the middle of the 20th Century. Yet for this disease that has taken many turns over many millennia, the first 15 years of the 21st century are exceptional. During that time, deaths from malaria—which are primarily concentrated in young, African children—fell dramatically, from 839,000 in 2000 to 438,000 in 2015. But progress is not inevitable. Over the last two years, malaria deaths and infections have plateaued. In some areas they are rising, and not just in Africa. For example, amidst the deteriorating infrastructure of Venezuela, malaria infections have surged by 69 percent. Some of the problem involves a failure to invest the resources required to sustain the fight. But there are also other long-term challenges, including growing resistance among malaria-carrying mosquitoes to the insecticides used in bednets and indoor spraying campaigns—control measures that have been very effective at reducing infections. Malaria parasites are spreading in Southeast Asia that are resistant to the lifesaving malaria medicine artemisinin—and to other malaria drugs as well. There are reports along the Cambodian border of “triple mutant” malaria parasites that are resistant to artemisinin and two other once-reliable malaria drugs. The biggest fear is that these superbugs could spread into India and then into the malaria strongholds of Africa. Our goal at PATH’s Malaria Vaccine Initiative (MVI) is to help develop vaccines to aid in fighting malaria. If you look at the battle against infectious diseases that once spread death and misery, like smallpox, polio, measles, and whooping cough, vaccines helped turn the tide. Vaccines could do the same for malaria. However, malaria-causing parasites, like all parasites that cause disease, are biologically complex in ways that have made them notoriously hard to subdue with vaccines. But despite the challenge, and because of substantial investments made over the last couple of decades, we are closer than ever to a world where malaria vaccines can join the battle. The malaria vaccine closest to deployment is called RTS,S/AS01, and was developed by GSK. No vaccines are currently in use against human parasitic diseases, including against Plasmodium, the mosquito-transmitted parasite responsible for causing malaria. RTS,S will be the first, rolled out next year through a pilot introduction that will make it available to 750,000 young children living in areas of Ghana, Kenya, and Malawi, where malaria is common. This is the first step to possible wider use across Africa, where, alongside currently used interventions like bednets, indoor residual spraying, and drugs, it could help save thousands of lives. Yet, even as RTS,S is rolled out, which is a huge achievement, we continue to develop the next generation of malaria vaccines. MVI is working with partners on creative ways to optimize the use of RTS,S that could translate to increased public health impact against disease and death in young African children, and potentially support its use in community-wide campaigns to accelerate parasite elimination. A few years ago, we looked closer at what was originally seen as a fluke finding from more than a decade ago: that delaying and reducing the third dose of RTS,S might boost its protection against malaria. The small trial in 2014 provided intriguing evidence that this approach does indeed improve the quality of the immune response from RTS,S. A series of larger trials are now underway to explore whether different dosing approaches could positively impact efficacy. These studies are being further leveraged, in concert with advances in medicine that enable isolation and testing of individual antibodies with a strong affinity for targeting a disease. These monoclonal antibodies (mAbs) are driving exciting new therapies targeting certain cancers and autoimmune conditions. We are at the cutting-edge of efforts to perform proof-of-concept studies with mAbs to answer critical scientific questions and determine their applicability, as a potential supplemental tool, to preventing infection by malaria-causing parasites. We’re also excited about the potential to fight malaria with transmission-blocking vaccines (TBVs). A TBV could prevent mosquitoes that feed on malaria-infected humans from passing along their parasites to new victims. While not providing immediate protection from infection, high coverage with a TBV in a community where malaria is common would steadily reduce the risk of getting malaria from a mosquito bite—as the parasite’s survival is pegged to a continuous cycle, moving between humans and mosquito. A successful TBV could prevent malaria from returning to areas where it has been eliminated. Malaria has been plaguing humans for thousands of years and the parasites that cause the disease are constantly evolving to evade our attempts at control. But while the current fight may have plateaued, the lesson of the last decades is that a unified, well-funded assault on malaria—one committed to developing a variety of tools and making them widely available—can produce substantial progress. If we continue to invest in malaria vaccine development, and fund other promising work now underway to create a new generation of drugs, insecticides, diagnostics, and other tools, while strengthening the programs and systems that deliver them, we can turn the tide. And from there, we can confidently set our sights on eliminating and eradicating the disease forever.

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. According to a report released last week by the Access to Medicines Foundation, just five companies are carrying out 63 percent of the urgently needed research and development projects for priority health areas such as HIV and AIDS, tuberculosis, Chagas disease, and leishmaniasis. This reliance on a small group of companies contributes to a fragile ecosystem, according to the report authors. A change in strategy for any of the companies could put access to medicines in low- and middle-income countries (LMICs) at risk. The Access to Medicines index, an independent report released every two years, ranks the world’s 20 largest pharmaceutical companies based on their efforts to make their medicines available in LMICs. This year, GlaxoSmithKline—the developer of a single-dose drug to prevent malaria relapse—tops the list of companies in the overall ranking.  Recruitment of women in Uganda has begun for a phase 3 clinical trial, which will assess if a long-acting injectable antiretroviral called Cabotegravir, administered every two months, is safe and effective as a form of Pre-Exposure Prophylaxis (PrEP) to reduce an individual’s risk of contracting HIV when exposed to the virus. This recruitment is part of a large-scale, five-year trial that will be conducted in six additional countries—including Kenya, Malawi, Botswana, Zimbabwe, South Africa, and Swaziland—among approximately 3,200 HIV-negative individuals who are at a high risk of contracting the virus. If Cabotegravir proves to be safe and efficacious, it would offer a new alternative for individuals on PrEP other than taking daily oral pills. A vaccine to prevent Zika virus infection was found to be safe and induce an immune response in an early stage trial, according to an announcement released on November 19 from developer Emergent BioSolutions Inc. and partner Valneva SE. The vaccine, VLA1601, was tested in two doses in 67 adult trial participants. The initial results contained analyses up to day 56, after the first vaccination. Final analysis will take place up to day 208 and is expected to be released in the first quarter of 2019. Emergent BioSolutions Inc. announced an exclusive worldwide licensing deal for Valneva SE’s Zika vaccine in July of last year.