On March 1, 2024, StarryGene (hereinafter referred to as "StarryGene")The IND application for "XMVA09 Injection," a Class I innovative gene therapy drug independently developed by StarryGene, has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration.XMVA09 Injection is the first gene therapy drug that combines dual-specificity targets with an intravitreal injection capsid, indicated for wet age-related macular degeneration (wAMD).As StarryGeneStrategic partner, PackGene congratulates StarryGene on the IND approval of XMVA09 injection!
▴ Screenshot of the official website of the Drug Review Center
As a participant and witness in the StarryGene XMVA09 Injection project,StarryGene is honored to provide a full set of CMC services for plasmids and AAV for this project, covering process development and optimization for plasmids and AAV, GMP production, analytical method development and validation, quality research, product release testing, stability studies, and comprehensive CMC documentation, accelerating the clinical trial application for the new gene therapy drug XMVA09 injection!
Dr. Cai Yuan, Co-founder and CEO of StarryGeneStarryGene Gave High Praise to the AAV Products and Services Provided by PackGene This Time: "Thank you, PackGene, for the one-stop AAV service provided for the IND of StarryGene's first product pipeline. During the cooperation with PackGene, the PackGene team demonstrated a high level of professionalism and dedication, closely collaborating with the StarryGene team, actively cooperating, precisely controlling the quality of AAV production, and efficiently and effectively advancing the IND progress of the XMVA09 project. With the strong support and full cooperation from PackGene, we are full of anticipation and confidence in the clinical progress of our later products! StarryGene always adheres to innovation, and we will work hand in hand with PackGene to provide patients with more treatment options!"
StarryGene sincerely wishes the XMVA09 project smooth progress and an early market launch, bringing hope of a cure to patients.In the future, PackGene Biotech will always adhere to the mission of "making gene therapy affordable for ordinary people," remain customer-oriented, and continuously...Deeply cultivate the development of vector technology and platform techniques to provide cell and gene therapy drug customers with one-stop CMC solutions, including the entire process from drug feasibility assessment to process development, analytical methodology development, pilot production, testing and release, regulatory submissions in both China and the U.S., and commercial production. This drives the research, development, and clinical translation of cell and gene therapy drugs, facilitating their regulatory submission.。
About XMVA09 Injection
XMVA09 Injection is a gene therapy drug independently developed by StarryGene. Compared with the 1-3 month injection cycle of traditional antibody therapies, gene therapy drugs can produce sustained therapeutic effects, with the potential to achieve lifelong efficacy with a single injection. XMVA09 Injection uses a novel AAV capsid, and through intravitreal injection, it can infect retinal pigment epithelium (RPE) cells adjacent to choroidal lesions, providing a more convenient approach for subsequent clinical applications. Additionally, XMVA09 Injection employs a bispecific antibody design, simultaneously targeting vascular endothelial growth factor (VEGF) and angiopoietin-2 (ANG-2), enhancing the drug's therapeutic efficacy and expanding its coverage to include patients who are insensitive to VEGF.
XMVA09 Injection Previously Showed Promising Clinical Outcomes in an IIT Study Conducted at the First Affiliated Hospital of the University of Science and Technology of China. Among the 6 enrolled wAMD subjects, all of whom had not received prior anti-VEGF prospective loading treatment before dosing, significant therapeutic effects were still observed. The first patient, who has been followed up clinically for nearly a year, demonstrated a marked improvement in BCVA. One of the top-performing subjects (high-dose group) showed an impressive increase of 17 letters in BCVA from baseline at the most recent follow-up visit. The interim results of the IIT study indicate that XMVA09 Injection is safe, well-tolerated, and has preliminarily met the expected efficacy evaluation criteria.
▴ ETDRS Letter Chart for BCVA Testing
About StarryGene
StarryGene is a high-tech enterprise that develops cutting-edge gene editing technologies and researches gene therapy products for ophthalmic diseases, focusing on the development of ophthalmic gene therapy drugs. The core team of StarryGene is a doctoral entrepreneurial team led by a "Distinguished Young Scholar," possessing two major core technology platforms on the R&D side: the AAV-Antibody Gene Drug Platform (Dual Antibody Optimization Platform, Capsid Screening Platform) and the Gene Editing Platform. The company is committed to developing gene therapy drugs for ophthalmic use that are independently accessible to people in China, actively advancing gene therapy into major ophthalmic indications. With ophthalmology as the breakthrough point—especially common eye diseases such as age-related macular degeneration—the company aims to help people in China see longer and better.
About PackGene
PackGene is a CRO & CTDMO technology company specializing in recombinant adeno-associated virus (rAAV) vector packaging, providing fast, cost-effective, high-quality, and scalable one-stop CMC solutions for the early research, preclinical development, clinical trials, and drug approval of recombinant AAV vector drugs for cell and gene therapy (CGT) companies. Since its establishment in 2014, as a leader in the AAV vector CRO service field, PackGene has delivered tens of thousands of customized AAV samples to customers from over 20 countries, including top multinational pharmaceutical companies and various research institutions worldwide. In the CTDMO service field, PackGene leverages five major technology platforms, including the π-Alpha™ 293 Cell AAV High-Yield Platform and the π-Omega™ Plasmid High-Yield Platform, to provide compliant services for the GMP-scale production needs of AAVs and plasmids with a complete quality and analysis system.
PackGene Biotech, with the mission of "making gene therapy affordable for the common people," is committed to accelerating the launch of innovative gene drugs and aims to become a long-term global partner in gene drug R&D and production. PackGene Biotech uses innovative technology as the foundation of its development, driven by two key areas: advanced vector production technology and groundbreaking vector tools, to establish its international brand in the CRO and CTDMO fields of gene therapy.