Rift Valley Fever

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Catalent said it will manufacture Galapagos’ clinical-stage CAR T therapy, dubbed GLPG5101, for upcoming clinical trials. Manufacturing will be done at Catalent’s site in Princeton, NJ, according to the Tuesday release. Kindeva Drug Delivery’s subsidiary Meridian Medical Technologies has secured a $129 million contract to supply DuoDote, an antidote for a chemical nerve agent, to the US Strategic National Stockpile, the company said Jan. 16. Dr. Reddy’s reported 83.6 billion rupees ($967 million) in revenues for the three months ending December 2024, which is 4% up from the 7.1 billion rupees ($82 million) it reported for the same period last year, the company said Thursday. The US contributes to 40% of its quarterly revenue. Solarbiotech, GPC Bio and Eleszto Genetika are consolidating into one company to provide services in biomanufacturing, the companies said Wednesday. The consolidation brings together over 100 engineers, scientists and executives. Afrigen Biologics has received $6.2 million from the Coalition for Epidemic Preparedness Innovations to develop an mRNA vaccine for Rift Valley fever, the company said Monday. Rift Valley fever is spread by mosquitoes, with outbreaks mainly reported in sub-Saharan Africa. Eli Lilly and Merck are collaborating with Purdue University to launch a new manufacturing consortium called the Young Institute Pharmaceutical Manufacturing Consortium, according to a Friday release. It will use technology like AI to improve domestic manufacturing in the US. AGC Biologics will manufacture and supply lentiviral vectors to Adaptimmune for the company to use in its T-cell therapy letetresgene autoleucel, as announced Jan. 16. Genethon and Eukarÿs have partnered to develop a technology to cut the cost of making gene therapies, according to a Thursday release. Eukarÿs will provide its engineered enzyme, dubbed C3P3, and Genethon will design and manufacture AAV vectors and provide its biomanufacturing facilities. In the UK, Bells Healthcare is recalling 17 batches of its cough syrup medicines containing the API dextromethorphan hydrobromide, according to a Tuesday announcement. Foreign material was found in some bottles and was categorized as a Class 2 recall.

Like malaria, there are concerns that Rift Valley fever rates could increase due to it being a climate-sensitive disease. Image credit: Shutterstock/mycteria. South African biotech Afrigen Biologics has secured a $6.2m grant from the Coalition for Epidemic Preparedness Innovations (CEPI) to develop the first mRNA-based vaccine against Rift Valley fever. The funding will see Afrigen’s researchers work with the International Vaccine Institute (IVI) to advance the mRNA candidate through preclinical testing and into a Phase I clinical trial in humans. The trial will either be conducted in South Africa or another country affected by an outbreak of the mosquito-borne disease. Rift Valley fever was first identified more than 90 years ago in Kenya. The disease occurs in humans after contact with infected animals, meaning pastoral farmers are commonly affected due to frequent interactions with livestock, though bites from infected mosquitoes can also transmit the virus. Whilst there are vaccines approved for animal use, none are yet marketed for human use. Around 1%-2% of infections are haemorrhagic, which can cause blindness, convulsions, encephalitis and bleeding. This more severe form of the disease has mortality rates in humans of around 50%. The World Health Organization (WHO) has reported outbreaks in Egypt, Kenya, Somalia and Tanzania in the 20th century, however, Rift Valley fever cases occurred outside Africa for the first time in September 2000, following livestock trade to the Middle East. Similar to malaria, there are concerns that Rift Valley fever rates could increase due to it being a climate-sensitive disease. CEPI stated the need for a new vaccine is due to the risk of the disease spreading to new areas or increasing in frequency or size due to changing weather events. WHO made Afrigen Biologics its mRNA Hub to scale mRNA vaccine development and production in low-income and middle-income countries. These regions are more adversely affected by infectious disease outbreaks, especially from mosquito-borne viruses. CEPI’s CEO Dr Richard Hatchett said: “A safe and effective Rift Valley fever mRNA vaccine made in Africa, for Africa, raises the bar in our response to future Rift Valley fever outbreaks, and paves the way to make rapid response mRNA vaccines against similar viruses that could emerge on the continent or in other low- and middle-income countries.” Although Afrigen’s candidate is the first mRNA-based vaccine for Rift Valley fever funded by CEPI, the organisation has previously funded further research. This includes a candidate developed at the University of Oxford, which will be evaluated in a Phase II clinical trial in Kenya, with CEPI providing $3.7m in funding for the study. The funding for Rift Valley fever comes in the same week as Tanzania confirmed an outbreak of Marburg virus , another haemorrhagic illness for which there are also no approved vaccines.

Integral Molecular, a company that develops vaccines and therapeutics, announced a five-year $8 million contract from the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID). The funding will be used to support the company's continuing research into emerging viruses recognized as potential pandemic threats. This marks the fourth similar contract awarded to the company in 15 years. Prior contracts allowed responses to virus outbreaks such as SARS-CoV-2, Zika, Ebola, dengue and chikungunya. Integral Molecular will utilize its mapping platform to pinpoint antibody binding sites (epitopes) on viruses, characterizing immune responses to viral threats. According to the company, this type of information can help scientists design effective vaccines. Additionally, Integral Molecular's Reporter Virus Particles (RVPs) is expected to play a vital role in the research. In a statement, the company said the non-replicative virus particles allow safe and high-throughput neutralization studies of highly pathogenic viruses with the use of standard laboratory facilities, and RVPs empower researchers to quickly develop vaccines and therapeutics. The NIAID contract will allow Integral Molecular to expand its research on potential pandemic threats, including Rift Valley Fever, Crimean-Congo Hemorrhagic Fever and Enterovirus D68 viruses. "We are grateful to NIAID for their continued support and trust in our capabilities," Benjamin Doranz, CEO of Integral Molecular, said in a statement. "Viral threats can emerge quickly and with little warning. This contract enables us to contribute to pandemic preparedness by focusing on understudied viruses identified as potential threats, using our technologies to make virology research more accessible to laboratories around the world." THE LARGER TREND In June, Integral Molecular, received ISO 9001 certification for the quality systems and processes used in their virology offerings. In April, Integral Molecular launched its Virus Neutralization Assay Services, which permitted researchers to rapidly obtain high-quality data to advance their vaccines and therapeutic antibodies. Neutralization Assay Services allow diverse applications including neutralization profiling for antibodies targeting viral proteins. That same month, researchers at the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), developed an artificial intelligence tool that predicts whether a patient will respond to cancer-treatment drugs using individual tumor cells, according to a study published in Nature Cancer. Conventional approaches to drug-patient matching center on bulk sequencing of tumor DNA and RNA. The new AI approach, PERCEPTION, takes advantage of single-cell RNA sequencing, which provides better-resolution data to fine-tune predicted drug responses. In 2022, Ro, a direct-to-patient care company, secured an agreement with the National Institute on Aging (NIA) to develop the Registry for Equal Access to Clinical Trials in Alzheimer's Disease (REACT-AD). Ro will employ its telehealth platform to screen and recruit patients who are at a heightened risk for developing Alzheimer's disease or other related dementia to join REACT-AD for potential participation in NIA-conducted and funded clinical trials. The NIA, part of the NIH, was charged with analyzing the data received and supervising the publication of research findings that emanate from REACT-AD.