Breakthroughs Blog: Research Roundup

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. Biotech companies Afrigen Biologics and Univercells on Tuesday announced a collaboration to pave the way for the development of the first African-owned COVID-19 vaccine through open-access intellectual property. The companies will focus on the development of a novel mRNA vaccine, using intellectual property from partners, with an emphasis on tackling two major challenges that have hindered COVID-19 vaccine rollout in Africa and other low- and middle-income countries: cold or super-cold chain requirements and a lack of local cost-effective production. The collaboration will be hosted in Cape Town, South Africa, by Afrigen, which also hosts the World Health Organization’s (WHO) global mRNA vaccine technology transfer hub, and the new agreement will build on expertise developed using the hub.At last week’s Kigali Summit on Malaria and Neglected Tropical Diseases (NTDs), Novartis and GlaxoSmithKline (GSK) each pledged to make significant new investments in research and development (R&D) for neglected diseases. Novartis committed $250 million over a period of five years to support work on malaria, Chagas disease, leishmaniasis, dengue fever, and cryptosporidiosis. The funding announcement was made as part of Novartis’ endorsement of the Kigali Declaration, a commitment to ending NTDs. GSK’s pledge—$1 billion over ten years—will be used to accelerate R&D of infectious diseases that disproportionately affect lower-income countries. This research will focus on new and disruptive vaccines and medicines to prevent and treat malaria, tuberculosis, HIV, NTDs, and antimicrobial resistance (AMR).Development of new antibacterial treatments is inadequate to address the escalating threat of antibiotic resistance, according to an annual WHO pipeline report released Thursday. The report, which assesses antibacterial drugs in preclinical and clinical development, describes the pipeline as stagnant and far from meeting global needs. Since 2017, just 12 antibiotics have been approved, 10 of which belong to existing classes with established mechanisms of AMR—demonstrating a major gap in discovery of antibacterial treatments, especially innovative treatments. Urgent, concerted investments in R&D by governments and the private sector are needed to accelerate and expand the antibiotic pipeline, according to WHO, especially for products that can make an impact in low-resource settings, which are most affected by AMR.

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 Friday, the US Food and Drug Administration (FDA) authorized Moderna’s and Pfizer’s COVID-19 vaccines for children as young as 6 months—making kids under 5 years old eligible for the first time. The decision followed a unanimous recommendation from a panel of independent advisers to the agency to authorize Pfizer’s three-dose vaccine for children 6 months to 4 years and Moderna’s two-dose vaccine for children 6 months to 5 years. The FDA also authorized on Friday Moderna’s vaccine, previously cleared in adults over 18, for children and adolescents ages 6 through 17 years old. Centers for Disease Control and Prevention Director Rochelle Walensky signed off on recommendation of the shots this past weekend, and vaccinations are beginning this week.The South African Health Products Regulatory Authority last week approved a sweet-tasting, heat-stable, “4-in-1” fixed-dose combination of four antiretroviral (ARV) treatments—abacavir, lamivudine, lopinavir, and ritonavir—specifically designed for infants and young children with HIV. The new formulation, developed by Cipla Limited and the Drugs for Neglected Diseases initiative (DNDi), does not require refrigeration, has a sweet taste, and is easy to administer to infants and children of different weights and ages, making it a significant improvement over existing pediatric ARV formulations. The accelerated review in South Africa is notable and encouraging for other countries with a high burden of HIV, according to DNDi, which also expressed hope that the necessary steps will be taken to ensure the broadest possible access to the treatment for children who need it.Japanese drugmaker Shionogi and the Global Antibiotic Research and Development Partnership (GARDP) announced Wednesday an agreement to expand access to a novel antibiotic for drug-resistant infections in lower-resource countries. The deal aims to provide access to cefiderocol, which is used to treat serious Gram-negative bacterial infections that may be resistant to other antibiotics, in countries that have experienced delayed or limited access to newer antibiotics. Under the agreement, GARDP will work with partners to manufacture and commercialize the antibiotic, developed by Shionogi, in up to 135 countries. The Clinton Health Access Initiative will also help navigate the technical, regulatory, legal, and economic barriers to getting the antibiotic to patients in these countries.

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, Moderna released preliminary results on its updated COVID-19 vaccine booster targeting omicron showing a significantly stronger immune response against the variant than the existing vaccine. The results come from a clinical trial among 814 volunteers testing a booster dose that combines the original vaccine with one that specifically targets omicron. The updated booster shot followed three earlier doses of Moderna’s vaccine. Among individuals with no evidence of prior COVID-19 infection, the new combination produced 1.75 times the level of neutralizing antibodies against omicron as the existing vaccine did alone. While the updated booster is promising against the omicron variant, some experts noted the evolving virus continues to lead to new variants and subvariants, potentially outpacing the ability to modify vaccines. US Food and Drug Administration advisers are set to meet June 28 to discuss which vaccine formulation would work best as a booster in the fall.The World Health Organization (WHO) published new guidelines last week for the treatment of people coinfected with visceral leishmaniasis and HIV, recommending better treatments based on studies conducted by the Drugs for Neglected Diseases initiative (DNDi), Médecins Sans Frontières, and partners in Ethiopia and India. In the Indian study, the new recommended treatment—a combination of injectable liposomal amphotericin B and oral miltefosine—demonstrated 96 percent efficacy after 210 days, compared to 88 percent for the current standard treatment. In the Ethiopian study, the new treatment demonstrated 88 percent efficacy after 58 days, compared to 55 percent for the standard treatment. The new regimen also reduces the use of injectable drugs and shortens the duration of treatment. Researchers plan to continue efforts to develop an even better treatment that will be completely oral, safe, and efficacious.The first participants have been vaccinated in a phase 3 study of an influenza vaccine developed by Moderna based on mRNA technology used in its COVID-19 vaccine. The vaccine, mRNA-1010, encodes for hemagglutinin glycoproteins of the four influenza strains recommended by WHO for the prevention of influenza. mRNA-1010 is the first of several influenza vaccine candidates intended to improve upon traditional vaccines, according to Moderna, by inducing broad, robust immune responses and employing the flexibility and speed of the mRNA platform manufacturing process. The trial will enroll around 6,000 adults in the southern hemisphere to evaluate the safety and immunological efficacy of the vaccine in comparison to a licensed seasonal flu vaccine. The company plans to run a confirmatory efficacy study for the vaccine as early as the 2022-23 northern hemisphere flu season.

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. COVID-19 vaccination during pregnancy appears to decrease newborns’ risk of infection with the virus, according to study results published Wednesday. The study, conducted in Norway, tracked 9,739 babies whose mothers received a second or third dose of a COVID-19 vaccine from Pfizer-BioNTech or Moderna while pregnant and 11,904 babies whose mothers were not vaccinated before or during pregnancy. COVID-19 infection was rare overall among the newborns, but risk of a positive PCR test during the first four months of life was 71 percent lower when the delta variant was dominant and 33 percent lower when omicron was dominant in babies whose mothers were vaccinated during pregnancy compared to babies whose mothers were unvaccinated. The findings could be in part a result of antibodies acquired from breastfeeding, according to a lead researcher, or due to vaccinated mothers being less likely to get COVID-19 and infect their infants.A team of researchers based at the University of Melbourne has discovered a new compound that could offer effective treatment against drug-resistant malaria. The compound, ML901, inhibits the malaria parasite by attacking the protein synthesis machinery from the inside and causing it to self-destruct, effectively making the parasite the agent of its own demise. During studies in both human blood cultures and an animal model, ML901 was able to kill malaria parasites that resisted currently used drugs and showed rapid and prolonged action. Based on the findings, the research team is now prepared to pursue the development of new antimalarial drug candidates.Individuals with HIV were able to achieve a lengthy period of virus suppression without antiretroviral therapy (ART) after receiving infusions of two broadly neutralizing antibodies (bNAbs), according to research conducted by the National Institute of Allergy and Infectious Diseases and partners. The research, published in Nature last week, indicates combination bNAb therapy can be highly effective in suppressing HIV in the absence of ART for extended periods, provided that antibody-resistant virus is not already present when individuals begin treatment. The authors suggest that infrequent infusions of combination bNAbs could offer a future alternative to daily ART for people living with HIV, though larger studies are needed to confirm the findings.