PackGene is delighted to extend warm congratulations to Starry (Xinmou) Biotech on the recent approval of their Investigational New Drug (IND) application for the pioneering gene therapy drug, XMVA09 Injection, by the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE). This milestone, achieved on December 6, 2023, marks a significant advancement in the treatment of wet age-related macular degeneration (wAMD). As a key strategic partner, PackGene is proud to be part of this groundbreaking development.

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.

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About PackGene

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.

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