Starrygene’s AAV Bispecific Antibody Gene Therapy for wAMD Advances to Phase II with Support from PackGene

HEFEI, China – May 26, 2025 – Starrygene Co., Ltd. announced today the initiation of a Phase II clinical trial for its proprietary gene therapy candidate, XMVA09 injection, a treatment for wet age-related macular degeneration (wAMD). This milestone establishes XMVA09 as the world’s first AAV bispecific antibody to enter Phase II and the first ophthalmic AAV drug based on a non-natural capsid in China to reach this stage, representing a significant advancement in ophthalmic gene therapy.

XMVA09 is an investigational AAV gene therapy designed to address the significant treatment burden of wAMD. Current anti-VEGF therapies require frequent intravitreal injections, often every 1-2 months, leading to high patient burden and potential for irreversible vision loss if treatment is interrupted. By delivering genes for a bispecific anti-VEGF-A and anti-Ang-2 antibody, XMVA09 aims to provide a long-acting therapeutic effect from a single intravitreal injection.

The progression to Phase II follows a successful Phase I clinical trial, which demonstrated a favorable safety and tolerability profile. The trial, for which XMVA09 received NMPA approval in March 2024, successfully enrolled and treated all subjects in early April of this year.

“As the first intravitreal injection-based bispecific antibody therapy, XMVA09 has the potential to substantially reduce the injection frequency for wAMD patients and could become a frontline maintenance therapy,” stated Dr. Bolong Miao, CMO of Starrygene. “We are confident that our collaboration with clinical experts and partners will ensure the steady progress of this trial to bring a new therapeutic option to patients.”

Dr. Yuan Cai, CEO of Starrygene, underscored the importance of key partnerships in achieving this milestone. “The successful progression of XMVA09 to Phase II is a critical validation of our technology and would not have been possible without the support of all our partners,” said Dr. Cai.

PackGene Biotech, a strategic partner to Starrygene, provided comprehensive CMC services from plasmid through AAV manufacturing. The contribution was integral to the development and successful clinical entry of XMVA09. PackGene’s role in the development and manufacturing process highlights a successful collaboration aimed at advancing innovative biopharmaceutical treatments for global health.

About Starrygene

Starrygene is a high-tech enterprise focused on developing gene therapy products for ophthalmic diseases. The company’s core team, led by a “National Outstanding Young Scientist,” leverages proprietary AAV-antibody gene drug and gene editing platforms. Starrygene is dedicated to creating innovative ophthalmic gene therapies for common diseases like wAMD, with the goal of improving long-term vision outcomes for patients.