Rift Valley Fever

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.

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. The Coalition for Epidemic Preparedness Innovations (CEPI) is partnering with and funding a research project for Afrigen Biologics to investigate if the use of synthetic DNA can speed up mRNA vaccine development. The synthetic DNA will be manufactured and supplied by the CDMO Syngoi. The research project will develop a vaccine for Rift Valley fever, according to a Tuesday press release. Bora Pharmaceuticals is gaining a 30.5% share in Tanvex Biopharma in a new partnership that will combine their manufacturing services. Bora will provide its 10 global manufacturing sites and Tanvex will provide its commercial facility in San Diego, CA. No financial details were given. Bharat Biotech is launching an oral cholera vaccine, dubbed Hillchol, to address cholera vaccine shortages. The company will manufacture this out of its facilities in Hyderabad and Bhubaneswar with a capacity to produce up to 200 million doses, the company said on Tuesday. John Kosolcharoen, CEO of two stem cell manufacturing companies, pleaded guilty on Monday for marketing products linked to patient hospitalizations. Since 2016, the two companies, called Liveyon LLC and Genetech Inc. have been making and shipping unapproved injectable stem cell products manufactured from human umbilical cord blood. Kosolcharoen lied to the FDA stating these were being sold for research purposes only, as per a DOJ press release on Tuesday. AstraZeneca’s manufacturing facility in Södertälje, Sweden, has achieved a 98% reduction in greenhouse gas emissions since 2015, the company said on Thursday. ScaleReady has awarded a $20 million grant to Stanford Medicine Laboratory for Cell and Gene Medicine to help the development of its CAR-T cell therapy manufacturing platform. The funding will be used to investigate the manufacturing tech in a Phase 1 clinical trial for Glypican 2 pediatric neuroblastoma and medulloblastoma, the company said on Tuesday. Trinity Capital is investing $35 million into drug delivery device manufacturer ApiJect Systems. The funding will be used to expand ApiJect’s manufacturing footprint with a new facility, according to a press release on Tuesday. Molecular Assemblies has received $4 million in funding from the Defense Advanced Research Projects Agency (DARPA) to further develop its DNA synthetic technology. The funding will be used for future tech transfers and to develop other software like gene synthesis, the company said on Wednesday. Injectable CDMO Simtra Biopharma Solutions has tapped Lonza’s VP of Biologics, Lidia Serina, as its new head of development services. Prior to working at Lonza, Serina held positions at GSK, Sanofi and CureVac. CDMO Huateng Pharma is expanding its services to include manufacturing pharmaceutical and veterinary APIs, chemicals and cosmetic ingredients, according to a press release on Wednesday. Lupin Pharmaceuticals is voluntarily recalling 4554 bottles of its cefixime oral suspension from the US due to an out-of-specification result. The class 2 recall started on Aug. 21, according to a FDA report published on Monday. Dr. Reddy’s Laboratories is also voluntarily recalling 103,298 bottles of 800 mg ibuprofen tablets after a specification study showed some levels of impurities. The bottles are being recalled from the US and Puerto Rico, and the process is ongoing. The FDA classified this as a class 2-level recall.

Plus, Olema and Novartis update an agreement for a breast cancer trial, and Roche shares long-term data for Vabysmo in macular edema. CEPI puts $25M into vaccine for Rift Valley fever: The Coalition for Epidemic Preparedness Innovation is giving $25.9 million to Wageningen Bioveterinary Research to advance a live-attenuated vaccine for Rift Valley fever into a Phase I/IIa trial. CEPI said Tuesday that heavy rain and flooding are linked to outbreaks of the virus, which is primarily spread by mosquitoes in sub-Saharan Africa. “A RVF vaccine will contribute to preparedness for potential virus emergence in yet unaffected regions like Europe,” WBVR’s Paul Wichgers Schreur said in a statement. — Jaimy Lee