XMVA09 Injection, Starry Biotech’s first attempt into gene therapy, has shown promising results in clinical studies. Conducted at the First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital), the trial reported no drug-related adverse effects. Notably, patients under observation displayed remarkable improvements in vision, proved by a significant increase in best-corrected visual acuity (BCVA) and the resolution of subretinal fluid without the need for additional antibody treatments.
A key factor in XMVA09’s safety profile is its innovative dual-antibody design and the use of a newly developed capsid for intravitreal (IVT) injection. This approach addresses various challenges such as patient safety and compliance, operational feasibility, and commercialization hurdles, which are frequently associated with subretinal injections.
PackGene has been an integral part of the XMVA09 Injection project. We have provided comprehensive support, including plasmids and a full Chemistry, Manufacturing, and Controls (CMC) services. This encompasses process development, GMP production, analytical method development, quality research, and thorough documentation, all contributing to the swift progression of the XMVA09 clinical trial application.
Dr. Yuan Cai, the co-founder and CEO of Starry Gene, commended PackGene Biotech for its exceptional support and collaboration, highlighting our professionalism and commitment to quality in advancing the XMVA09 project.
Looking ahead, PackGene Biotech is committed to its mission of making gene therapy more accessible. We will continue to focus on vector process and technology development, offering comprehensive CMC solutions for drug innovation and promoting the application of gene therapy drugs.
About Starry (Xinmou) Biotech:
Specializing in cutting-edge gene editing technologies and gene therapy product development for ophthalmic diseases, Starry Biotech is dedicated to making advanced ophthalmic gene therapy drugs accessible in China. The company is keenly focused on addressing major ophthalmic conditions like age-related macular degeneration, with the goal of improving vision and quality of life for many.
Check out PackGene’s AAV manufacture and AAV Analytical services
PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.
Related News
Skyline Therapeutics Receives FDA Orphan Drug Designation for Gene Therapy for Retinitis Pigmentosa
BOSTON & SHANGHAI, September 2, 2024 – Skyline Therapeutics, a gene therapy company focused on innovative treatments for rare and severe diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SKG1108....
Novavax Receives Emergency Use Authorization for Updated Covid-19 Vaccine
Novavax has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its updated Covid-19 vaccine, NVX-CoV2705, joining other vaccine manufacturers in addressing evolving virus variants. The EUA permits the use of Novavax's...
Turn Biotechnologies Reports Historic Skin Cell Rejuvenation Breakthroughs at ESDR this Week
Company will present data from its successful rejuvenation of fibroblasts and keratinocytes to influential gathering of international dermatologists MOUNTAIN VIEW, Calif., Sept. 4, 2024 /PRNewswire/ -- Turn Biotechnologies, a developer of novel mRNA medicines and...
H5 influenza vaccines: What needs to be done to reduce the risk of a pandemic
As the global threat of H5N1 influenza looms with outbreaks across species and continents including the U.S., three international vaccine and public health experts say it is time to fully resource and support a robust strategy to address this and future potential...
Related Services