XingMou Biotech's AAV Gene Therapy XMVA09 Receives IND Acceptance for New Indication in Diabetic Macular Edema (DME)

May 31, 2024, StarryGene announced that itsThe second IND application for the self-developed gene therapy Class I innovative drug "XMVA09 Injection" has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The newly applied indication is Diabetic Macular Edema (DME).On March 1, 2024, the IND application for XMVA09 injection for the treatment of wet age-related macular degeneration (wAMD) received clinical tacit approval from the CDE.

Image Source: Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration

Diabetic Macular Edema: A Common Ocular Complication in Diabetic PatientsDiabetic macular edema is a common ocular complication among diabetic patients, primarily affecting the macular region at the center of the retina. The macula, a crucial area responsible for visual acuity, causes vision loss or even blindness when edema occurs. The core objective in treating this eye condition is to maintain and improve vision, with significant clinical treatment demand. Currently, anti-vascular endothelial growth factor (anti-VEGF) represents the safest and most effective therapeutic target in clinical practice.

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 and are expected to achieve...One injection for life-long effectiveness, greatly benefiting patients. XMVA09 injection is adopted byA novel AAV capsid that can infect 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 employs 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 insensitive to VEGF.

For the wAMD indication, the XMVA09 injection previously demonstrated promising clinical outcomes in an IIT study conducted at the First Affiliated Hospital of the University of Science and Technology of China. The 6 enrolled wAMD subjects all showed...Without receiving anti-VEGF prospective loading treatment, still demonstrated excellent therapeutic effects. The first patient with the longest observation period has undergone treatment after medication.15-Month Clinical Follow-Up Observation, patients showed a significant increase in BCVA. The interim results of the IIT showed,XMVA09 Injection Demonstrates Reliable Safety, Good Tolerability, and Preliminary Achievement of Efficacy Study Expectations。

Dr. Cai Yuan, Founder and CEO of StarryGeneStarryGene stated, "Allowing patients to see farther and better has always been the philosophy upheld by StarryGene. At the outset of XMVA09 injection's project initiation, we had already laid out plans for multiple indications. As non-clinical research data continues to accumulate, we have gained a deeper understanding of the product’s characteristics. The expansion application for the DME indication follows scientific principles, progressing in a systematic and strategic manner! This is the result of years of relentless effort by the StarryGene team, and also reflects StarryGene’s commitment to treating ophthalmic diseases. We thank our team and partners for their strong support and assistance with this project. We will continue to work hard to address unmet clinical needs and provide patients with safer and more effective revolutionary treatments!"

Dr. Bolong Miao, Chief Medical Officer of StarryGeneStarryGene stated, "For the wAMD indication, the XMVA09 injection was initiated in an IIT study at the First Affiliated Hospital of the University of Science and Technology of China in February 2023. Currently, we have accumulated substantial safety and efficacy data, genuinely observing the benefits that XMVA09 brings to patients. This has given StarryGene confidence to further expand into the DME indication. StarryGene believes that the XMVA09 injection will offer diabetic macular edema patients a treatment option with better outcomes and improved compliance."

About StarryGene:

StarryGene is a high-tech enterprise that develops cutting-edge gene editing technologies and 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," with two key technology platforms on the R&D side: the AAV-Antibody Gene Drug Platform (including a bispecific antibody optimization platform and a 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. Using ophthalmology as a breakthrough, particularly age-related macular degeneration and other common eye diseases as the main focus, StarryGene aims to help people in China see longer and better.