Xingmou Biotechnology's AAV Gene Therapy XMVA09 Receives IND Approval in China for Wet AMD Treatment

Mar 01, 2024 13:38 CST Updated 13:38

StarryGene

Gene Therapy Drug Developer

2024Year3Month1Day，StarryGene (hereinafter referred to“StarryGene”）Self-developed Gene TherapyIClass Innovative Drug“XMVA09Injection”New Drug Clinical Trials(IND)The application has been approved by the National Medical Products Administration (NMPA).(NMPA)Approval。XMVA09InjectionIt is the first gene therapy drug that achieves both bispecific targeting and intravitreal injection of the capsid.Indication: Wet Age-Related Macular Degeneration (wAMD）。

Source of the image: CDE official website

Wet age-related macular degeneration is a common fundus disease, characterized by abnormal growth and leakage of blood vessels in the macular region of the retina, leading to a sharp decline in vision. This disease is one of the main causes of blindness in the elderly, significantly impacting the quality of life for patients.

XMVA09 Injection is a gene therapy drug independently developed by StarryGene. Compared with the 1-3 month injection cycle of traditional antibody therapy drugs, gene therapy drugs can produce a sustained therapeutic effect and are expected to achieve...One injection for life, greatly benefiting patients. XMVA09 injection is adoptedA novel AAV capsid that can infect the retinal pigment epithelium (RPE) cells adjacent to choroidal lesions through intravitreal injection., providing a more convenient pathway for subsequent clinical applications. In addition, the XMVA09 injection utilizes a bispecific antibody design,Simultaneously targeting dual pathways of vascular endothelial growth factor (VEGF) and angiopoietin-2 (ANG-2), improved the therapeutic effect of the drug, and expanded the coverage for patients who are insensitive to VEGF.

XMVA09 Injection Previously Showed Good Clinical Results in an IIT Study Conducted at the First Affiliated Hospital of the University of Science and Technology of China. The 6 wAMD Subjects Enrolled in the Study, Prior to Drug Administration, AllWithout receiving anti-VEGF prospective loading treatment, still demonstrated excellent therapeutic effects. The first patient with the longest observation period has undergone treatment after medication.Nearly one year of clinical follow-up observation, the patient had a significant increase in BCVA. The participant with the best clinical benefit (high-dose group) at the most recent follow-upBCVA improved by an impressive 17 letters from baseline.. The interim results of the IIT showed that,XMVA09 Injection Demonstrates Reliable Safety, Good Tolerability, and Preliminary Achievement of Efficacy Study Expectations。

StarryGene Founder and CEO, Dr. Cai YuanStarryGene announced: "We are very pleased to announce the approval of XMVA09 injection IND. This is the result of years of relentless efforts by the StarryGene team and also a reflection of StarryGene's commitment to treating ophthalmic diseases. Thanks to our team and partners for their strong support and assistance in this project. We will continue to work hard to meet unmet clinical needs and provide patients with safer and more effective revolutionary therapeutic drugs!"

Dr. Bolong Miao, Chief Medical Officer of StarryGeneStarryGene stated, "The IIT research on XMVA09 injection conducted at the First Affiliated Hospital of the University of Science and Technology of China has achieved encouraging interim results. Regarding the recent IND approval, the preliminary preparations for initiating the Phase I clinical study are almost complete, and we believe it will be fully launched very soon. StarryGene believes that as the clinical trials progress, XMVA09 injection will bring new hope to patients with wet age-related macular degeneration."

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," with 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 the independent development of ophthalmic gene therapy drugs in China, actively promoting the application of gene therapy to major ophthalmic indications. With ophthalmology as the breakthrough point, especially common ophthalmic diseases represented by age-related macular degeneration, StarryGene aims to help the Chinese see longer and better.

E.N.D

In order to enable everyone to learn and communicate with each other better,"WeChat Official Account 'Cell Gene Therapy' Team"A WeChat group for cell therapy and gene therapy discussions has been established. Interested friends can scan the QR code below to add the editor's WeChat and join the cell therapy and gene therapy discussion group.。