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 is a CRO & CDMO technology company that specializes in packaging recombinant adeno-associated virus (rAAV) vectors. Since its establishment in 2014, PackGene has been a leader in the AAV vector CRO service field, providing tens of thousands of custom batches of AAV samples to customers in over 20 countries. PackGene offers a one-stop CMC solution for the early development, pre-clinical development, clinical trials, and drug approval of rAAV vector drugs for cell and gene therapy (CGT) companies that is fast, cost-effective, high-quality, and scalable. Additionally, the company provides compliant services for the GMP-scale production of AAVs and plasmids for pharmaceutical companies, utilizing five technology platforms, including the π-Alpha 293 cell AAV high-yield platform and the π-Omega plasmid high-yield platform. PackGene's mission is to make gene therapy affordable and accelerate the launch of innovative gene drugs. The company aims to simplify the challenging aspects of gene therapy development and industrialization processes and provide stable, efficient, and economical rAAV Fast Services to accelerate gene and cell therapy development efforts from discovery phase to commercialization.

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