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
Exploring Tau Protein’s Role in Glaucoma: New Insights and Therapeutic Potential
Glaucoma, a chronic neurodegenerative disorder, leads to irreversible vision loss by damaging retinal ganglion cells (RGCs) and the optic nerve, often associated with increased intraocular pressure (IOP). Despite the benefits of IOP-lowering treatments, the underlying...
FDA-mandated CAR-T monitoring period could be halved, say researchers
In patients with diffuse large B-cell non-Hodgkin lymphoma (DLBCL), the two hallmark post-chimeric antigen receptor (CAR)-T therapy toxicities are extremely rare after two weeks, supporting a shorter, more flexible toxicity monitoring period, according to a study...
Ancestral CRISPR-Cas13 Ribonucleases Discovered: Implications for Genome Editing
In a pioneering study published in *Science*, a team of researchers led by Peter H. Yoon and Jennifer A. Doudna from the University of California, Berkeley, has made a remarkable discovery in the realm of CRISPR technology. The team has identified an ancestral clade...
KBI Biopharma Expands Manufacturing Contract with Global Pharmaceutical Company
KBI Biopharma Inc., a JSR Life Sciences company and global cGMP contract development and manufacturing organization (CDMO), has extended and expanded its manufacturing contract with a leading global pharmaceutical company. Originally initiated in 2020, the renewed...
Related Services
