Anna Kovacevich

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 novel antibody treatment designed to prevent malaria was able to protect against infection in a majority of participants in a phase 1 trial, according to results published last week. The method utilizes a monoclonal antibody, dubbed L9LS, that is optimized to target a protein used by the malaria parasite to infect hosts. The recent trial tested three different doses of the antibody treatment, administered either intravenously or subcutaneously, among 17 healthy volunteers. All participants were then exposed to malaria-carrying mosquitos, and just two participants developed malaria in the weeks following. The results provide proof of principle for a next-generation monoclonal antibody, researchers say, suggesting it could be an important tool in eradicating malaria when used in combination with effective vaccines and other prevention measures.  The US National Institutes of Health is preparing to launch a clinical trial evaluating methods to stretch doses of Jynneos, the only vaccine approved for use against monkeypox in the United States. Researchers will study two adjusted regimens in comparison to the current method, which involves two full doses given 28 days apart. One test group will receive a single dose of the vaccine, and another group will receive two doses, given 28 days apart, that are each one-fifth of a full dose and administered intradermally—or into the skin, rather than under the skin—which has potential to activate powerful immune responses. The study will test whether the dose-sparing approaches generate antibody levels similar to those of the full, two-dose regimen, as well as compare the tolerability and reactogenicity of the two different routes. Results are expected toward the end of 2022.A clinical trial in South Africa has shown that a new vaccine candidate for tuberculosis (TB) is safe for newborns and has fewer side effects than the existing TB vaccine, Bacillus Calmette Guérin (BCG). The experimental vaccine, VPM1002, was developed by genetically modifying the attenuated BCG vaccine strain so that immune cells better recognize the pathogens, in an effort to increase safety and improve efficacy for immunocompromised children. The phase 2 trial compared VPM1002 with BCG in HIV-exposed and non-HIV-exposed newborns and examined the associated safety and immune response, ultimately finding the vaccine candidate safe in both groups of newborns, with fewer side effects than BCG as well as a similar immune response. Researchers plan to continue to evaluate the vaccine among newborns, including its ability to protect against infection, in a phase 3 trial.

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 Medicines Patent Pool (MPP) and ViiV Healthcare last week announced a new voluntary licensing agreement that would allow for generic manufacturing and distribution of long-acting cabotegravir in an effort to expand access to the HIV prevention drug. Long-acting cabotegravir—an injectable form of preexposure prophylaxis, or PrEP—can provide two months of protection against HIV infection with a single shot, while most other forms of PrEP require daily pills. The new licensing agreement between the United Nations-backed MPP and ViiV will let select generic manufacturers apply for sublicensing to develop, manufacture, and supply generic forms of the drug in 90 countries—pending regulatory approvals—where the HIV burden and potential use of cabotegravir is the highest.The Coalition for Epidemic Preparedness Innovations (CEPI) is supporting an initiative to develop a standardized approach to test the performance of vaccines being used or in development against monkeypox. The new funding, announced days after the World Health Organization declared monkeypox a public health emergency of international concern, will go to the UK Medicines and Healthcare products Regulatory Agency and the UK Health Security Agency to pursue tools able to assess the strength and duration of immune responses generated by current vaccines, as well as for tests used to detect monkeypox antibody levels. These tools will subsequently be made available to the global scientific community for free, apart from administration fees, enabling a standardized assessment between countries documenting vaccine performance against monkeypox, according to CEPI.Researchers have identified a specific area of the SARS-CoV-2 spike protein as a good target for pan-coronavirus vaccines, making a promising advance in the development of a shot to protect against COVID-19 variants and common colds. A universal coronavirus vaccine would need to induce antibodies that recognize and neutralize a wide range of viruses—a challenge, given the complexities of the coronavirus family, according to scientists. In the new study, scientists investigated whether antibodies targeting the S2 subunit of SARS-CoV-2’s spike protein could also neutralize other coronaviruses, including a strain of the common cold as well as several COVID-19 variants, and found promising results among mice. The researchers plan to continue to study the method as potential pan-coronavirus vaccine target and evaluate how it could be integrated with currently licensed vaccines.

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. Following the remarkable success of the first COVID-19 vaccines, developed at unprecedented speeds, investment in next-generation shots has so far fallen short, according to some experts. Nasal vaccines, in particular, experts say could prove more effective at preventing COVID-19 infections than intramuscular shots, as they concentrate immune protection in the upper airway and induce mucosal immune responses where the virus typically enters the body. Several nasal vaccine candidates are in development in the United States—though primarily remain in preclinical or early-stage clinical trials—as well as globally, including phase 3 trials in India and China. The National Institute of Allergy and Infectious Diseases, for example, is funding early research on a protein-based nasal spray as well as an mRNA vaccine delivered into the nose using nanoparticles, though any successful nasal vaccine is likely years away from becoming available.As monkeypox cases continue to rise globally, experts and leaders are looking at health technologies with potential to combat the virus—including repurposed smallpox vaccines that have begun to be deployed, predominantly in high-income countries. In addition to vaccines, scientists are evaluating existing drugs that could serve as treatments against monkeypox, for which there are no specific treatments licensed. A recent study in JAMA analyzed several preexisting drugs, including antivirals brincidofovir and tecovirimat, both of which have been tested among monkeypox patients in the past with varying success. The ongoing uncertainty surrounding treatments for the new outbreak highlights the lack of evidence-based therapeutics for monkeypox, according to the journal article, as well as the inequities in the global response as countermeasures have been stockpiled by high-income countries but remain limited in monkeypox-endemic countries.In a new study, researchers describe how a Lassa virus protein drives infection by harnessing a cellular protein in human hosts, as well as identify how future therapies could target this interaction to treat patients. The research suggests that disrupting the link between Lassa polymerase—a protein encoded by the virus—and a specific host protein it interacts with—GSPT1—could stop Lassa virus infection. In pursuit of this, the research team identified an existing drug candidate, CC-90009, that has been shown to destroy GSPT1 proteins and is currently being examined in clinical trials as a cancer therapy. In early experiments, CC-90009 significantly reduced Lassa virus growth without obvious cell toxicity, and researchers plan to continue evaluation in animal models. There is currently no antiviral drug that specifically targets Lassa virus.

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 Wednesday, the US Food and Drug Administration (FDA) authorized Novavax’s COVID-19 vaccine for individuals 18 and over, making it the fourth COVID-19 shot recommended by the agency for use in the United States. The Novavax vaccine is also the first authorized protein-based COVID-19 shot, which works by delivering a protein present on the virus’s service, along with a chemical adjuvant that spurs the immune system to recognize it. The new authorization is for a series of two shots, separated by three weeks; it does not cover use of the Novavax vaccine as a booster shot, which the agency will need to evaluate separately. The vaccine must still be recommended by the Centers for Disease Control and Prevention (CDC) before becoming widely available; the United States has acquired 3.2 million doses of the vaccine to be shipped to states once authorized by the CDC director.The National Institutes of Health has launched a clinical trial of an mRNA vaccine candidate to prevent Nipah virus infection, a zoonotic disease with no currently authorized vaccine or treatment. The phase 1 clinical trial will test an mRNA-based vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate its safety, tolerability, and ability to generate an immune response in 40 healthy adults. NIAID’s Pandemic Preparedness Plan, published earlier this year, established a framework to study viruses of pandemic potential, like Nipah, and prioritize research on prototype pathogens. The newly launched study is the first clinical trial to use the prototype pathogen approach since the plan’s publication.In a new report, the World Health Organization outlines the pipeline of bacterial vaccine candidates and emphasizes the urgent need to step up investment and research into vaccines that can help combat antimicrobial resistance (AMR). The analysis is the first to provide detailed analysis of the pipeline of vaccines with potential to address drug resistance from priority pathogens, identifying 61 vaccine candidates in various stages of clinical development and 94 candidates in preclinical development. While highlighting existing vaccines and the promising candidates in late-stage development, the report also notes a critical need to accelerate trials of vaccines to address AMR and makes a case for bolstered investment that can lead to increased global health equity.

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 Wednesday, the Stop TB Partnership launched a new global plan to end tuberculosis (TB) by 2030. The plan requires a total of $250 billion in funding, $40.2 billion of which would go toward accelerating the research and development of new TB diagnostics, medicines, and vaccines—including a specific goal of developing a new TB vaccine by 2025. There is currently only one licensed TB vaccine, which was approved more than 100 years ago and has limited benefit in adult populations. Several promising candidates are in clinical trials, including four in advanced stages of development, making it possible to have a new TB vaccine by 2025—if sufficient funding and political will is present to push things forward.A new, “all-in-one” vaccine showed early promise in protecting against a variety of coronaviruses, including COVID-19, SARS, and MERS, according to preclinical study results published last week. The mosaic-8 vaccine was able to train immune systems to recognize eight viruses at once in animal studies, demonstrating proof of concept for its ability to block a range of betacoronaviruses—the subgroup containing the virus that causes COVID-19. The Coalition for Epidemic Preparedness Innovations (CEPI) has pledged $30 million to begin clinical trials of the experimental vaccine in humans. The phase 1 trial will take place at Oxford University, which collaborated with the California Institute of Technology to develop the vaccine, and will likely take at least a year.Advances in science, in conjunction with rising investment in research, have led to the development of promising new treatment candidates for several neglected tropical diseases (NTDs) in recent years—though little progress has been made on the NTD subset of parasitic worm diseases. In a new study published last week, researchers outline these NTD research trends, noting that despite a long-standing lack of innovation in drugs for neglected diseases, partnerships between public, private, and nonprofit entities have enabled major progress in developing treatments for several target NTDs like leishmaniasis, Chagas disease, and sleeping sickness. This same progress has not been seen, however, among parasitic worm diseases like schistosomiasis, as research is often left at early stages. Bolstered drug discovery efforts focused on these diseases are needed in order to combat their high global prevalence, the researchers conclude.

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 World Bank on Thursday approved the creation of a prevention, preparedness, and response financial intermediary fund, or FIF, intended to strengthen national, regional, and global capacities to prevent and prepare for future pandemics. The FIF will pool dedicated resources for pandemic preparedness and response, starting with initial pledges of $1.1 billion—though this represents only around 10 percent of the $10.5 billion the fund will need annually, according to the World Bank and World Health Organization (WHO). WHO will provide technical leadership for the FIF in close collaboration with the World Bank; the scope and structure of its operations and board, however, have not yet been determined. The FIF will also incentivize increased investments from countries, enhance partner coordination, and serve as a platform for advocacy.The US Food and Drug Administration is advising vaccine makes to reformulate their COVID-19 shots to target the BA.4 and BA.5 omicron subvariants, which now account for the majority of US infections and have been growing in prevalence globally, alongside the original strain of the virus. The updated recommendation, announced last week following a vote by a panel of outside experts, is meant to leave enough time for vaccine makers to adapt their formulas and manufacture updated shots to provide broader protection against the virus amid potential fall and winter booster campaigns. The newer forms of the shots will only be offered as boosters, while the primary series of shots will continue to use the original vaccines given their maintained effectiveness against severe outcomes of the virus.The National Institutes of Health has begun testing a universal influenza vaccine that could provide long-lasting protection against a wide range of seasonal flu viruses as well as those with pandemic potential. The vaccine candidate, BPL-1357, is composed of four strains of non-infectious, chemically inactivated, low-pathogenicity avian flu virus. The phase 1 trial, which follows successful preclinical studies, will evaluate BPL-1357 delivered both intranasally and intramuscularly for safety and ability to induce immune responses among up to 100 volunteers. With this new vaccine candidate, scientists are attempting to induce a comprehensive immune response closely mimicking immunity from natural flu infection, as opposed to focusing on inducing immunity to a single viral antigen.