NEW YORK – Abu Dhabi's Department of Health and the Abu Dhabi Investment Office this week signed a memorandum of understanding with GlaxoSmithKline to launch a multiomics research institute in the country. The institute's goal will be to accelerate oncology-focused genomic science and precision medicine by leveraging Abu Dhabi's biotechnology infrastructure.
Precision Biosciences this week said the US Food and Drug Administration has granted fast-track designation for PBGENE-HBV, an in vivo gene editing therapy for chronic hepatitis B. PBGENE-HBV is designed to eliminate cccDNA that HBV uses to replicate and to inactivate integrated HBV DNA in hepatocytes. After garnering FDA clearance for its investigational new drug application in March, Precision Biosciences began evaluating the treatment in the Phase I ELIMINATE-B trial and will share readouts from it throughout 2025. A sponsor can meet with the FDA more frequently to get advice on fast-track designated agents, submit data on a rolling basis, and apply for accelerated approval or priority review.
LinusBio this week announced that its ClearStrand-ASD assay would be available at a reduced cost through a partnership with advocacy organization Autism Speaks. ClearStrand-ASD helps physicians rule out autism spectrum disorders (ASD) in children up to 36 months old by assaying biomarkers found in hair samples. The collaboration supports two initiatives. The first, Autism Response Team, provides families with educational materials concerning ClearStrand-ASD, along with discount codes for the test. The second, Empower Summit & Challenge, is a series of two-day events held in five US cities, aimed at addressing challenges in the ASD community.
Thermo Fisher Scientific said this week that it has opened a new Advanced Therapies Collaboration Center in Carlsbad, California. The facility is designed to accelerate the development and commercialization of cell therapies, specifically by supporting biotech, biopharma, and translational customers developing cell-based immunotherapies, Thermo Fisher said. Through the new center, cell therapy developers can leverage Thermo Fisher’s product, technology portfolio, and knowledge to create comprehensive, end-to-end manufacturing workflows that can scale to enable their clinical and commercial needs.
The US Food and Drug Administration has granted breakthrough therapy designation to UniQure's investigational Huntington's disease gene therapy AMT-103, the Amsterdam-based biotech said this week. The regulator grants this designation to sponsors developing drugs that may offer substantial improvement over available treatments for serious conditions. The FDA awarded UniQure's AMT-103 this designation based on clinical evidence from ongoing Phase I/II trials indicating that the gene therapy slows Huntington's disease progression. UniQure has previously said that it plans to discuss with the FDA potential expedited clinical development pathways, such as accelerated approval, for AMT-103.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on Precision Medicine Online.