XingMou Biotech Announces Global First-in-Class AAV Bispecific Antibody Gene Therapy XMVA09 Enters Phase II Clinical Trial for wAMD

May 26, 2025 10:42 CST Updated 10:42

StarryGene

Gene Therapy Drug Developer

Recently, StarryGene successfully held the Phase II clinical trial initiation meeting for its self-developed XMVA09 injection to treat wet age-related macular degeneration (wAMD), markingXMVA09 Injection Becomes the World's First AAV Bispecific Antibody to Enter Phase II Clinical Trials, and Also the First Ophthalmic AAV Drug Based on Non-Natural Capsids in China to Reach Phase II, Opening a New Chapter in Ophthalmic Gene Therapy Both in China and Globally.

wAMD is the leading cause of irreversible vision loss in people over 50, impacting the quality of life for approximately 200 million individuals. Under the current standard treatment regimen, patients require intravitreal injections of anti-VEGF drugs every 1-2 months. Interruption or insufficient treatment can lead to a decline in long-term efficacy, resulting in irreversible vision loss. Gene therapy, however, holds the potential for "one-time dosing, lifelong effectiveness." XMVA09 Injection, developed by StarryGene, is the world’s only gene therapy drug that combines dual-target antibodies and is administered via intravitreal injection. Utilizing an AAV vector, it carries genes encoding a bispecific antibody targeting VEGF-A and Ang-2. Upon intravitreal injection, it directly targets RPE cells to express therapeutic proteins, achieving long-term treatment of wAMD.

XMVA09 Injection was approved by the NMPA to enter the clinical stage in March 2024. In early April this year, it successfully completed the enrollment and treatment of all subjects in the Phase I clinical trial. Preliminary results have shown good safety and tolerability, with efficacy data demonstrating significant market advantages. The Phase II kickoff meeting for XMVA09 Injection in the treatment of wAMD, held in Tianjin, brought together a top expert team in the field of wAMD treatment in China, the core management team of StarryGene, and representatives of clinical research collaborators to jointly discuss the Phase II clinical research plan and execution strategy for XMVA09 Injection.

StarryGene CMO Dr. Bollong MiaoRepresentation"XMVA09 Injection, as the first innovative dual-antibody therapy administered via intravitreal injection, has the potential to significantly reduce the injection frequency for patients with wAMD, becoming a first-line maintenance therapy for wAMD in the future. We firmly believe that, with the rich clinical experience of the expert team and the strong support of close cooperation from all parties, the clinical trials of XMVA09 Injection will proceed steadily, bringing good news to many patients as soon as possible."

StarryGene CEO Dr. Cai YuanRepresentation"The launch of this pivotal Phase II clinical trial marks a key milestone for StarryGene and is a crucial step in validating the technological advantages of XMVA09 injection. The excellent clinical benefits and smooth progress into the next stage would not have been possible without the support of all our partners, the trust of our shareholders, and the dedication and collaboration of the entire team. StarryGene will continue to focus on research and development, utilizing cutting-edge gene therapy technology to create leading innovative products that benefit a broad patient population."

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 Scientist," 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 ophthalmic gene therapy drugs that are independently accessible to the Chinese population, actively promoting gene therapy into major ophthalmic indications. With ophthalmology as the breakthrough point—especially common ophthalmic diseases represented by age-related macular degeneration—the company aims to help the Chinese see longer and better.

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