Taipei, Taiwan/ March 31^st, 2022

Allgenesis Biotherapeutics Inc., a clinical-stage specialty pharmaceutical company focused on developing novel ophthalmic drugs, today announced the clearance of the Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for AG-73305, a humanized, bi-specific Fc-fusion protein designed to simultaneously block VEGFs and integrins for the treatment of retinal diseases.

“The IND clearance of AG-73305 is a significant milestone for our company,”, said Dr. Madhu Cherukury, CEO of Allgenesis, “and we are excited to have the opportunity to advance our retinal program to the clinic. We expect to see treatment improvements with AG-73305 over anti-VEGF monotherapies and aim to broaden the scope of clinical development of our retinal program to include neovascular age-related macular degeneration (nAMD), retinal vein occlusion (RVO), and other retinal indications.

This is a multicenter, open-labeled, Phase 2a study to evaluate the safety, tolerability, and efficacy of intravitreal AG-73305 in patients with DME. The study’s goal is to assess whether AG-73305 has an acceptable safety profile and whether AG-73305 demonstrates some clinical beneficial effects on improvements to BCVA and central subfoveal thickness. 

“AG-73305 is a humanized IgG1 bispecific Fc-fusion protein that inhibits multiple VEGF and integrin targets, and is being developed to treat patients with retinal neovascularization, macular edema, fibrosis, and inflammation which are not fully controlled with current anti-VEGF monotherapies,” said Dr. Sunil Patel, Chief Medical Officer. “We look forward to the clinical benefit that AG-73305 treatment can potentially provide to DME patients.”

Allgenesis plans to begin a Phase 2a trial in patients with diabetic macular degeneration (DME) as early as 2Q22 and expects to report interim data in 2H22. In 2021, Allgenesis entered into a licensing agreement with Affamed Therapeutics, a Shanghai-based biopharmaceutical company, for the development and commercialization of AG-73305 in Greater China, South Korea, and multiple ASEAN markets.

About Allgenesis Biotherapeutics Inc.

Allgenesis is a clinical-stage biopharmaceutical company headquartered in Taipei, Taiwan. The company is focused on the research and development of novel medicines for the treatment of eye diseases. Current projects in the pipeline include AG-73305, a potential blockbuster drug for the treatment of DME, nAMD, and other retinal diseases such as RVO, and AG-80308 for Dry Eye Disease.

About AG-73305

AG-73305 is a humanized, bi-specific Fc-fusion protein designed to simultaneously block VEGFs and integrins for the treatment of DME, nAMD, RVO, and other retinal diseases. AG-73305 is composed of a VEGF-trap and a disintegrin that blocks various key integrin receptors. AG-73305 has the potential to treat both anti-VEGF responders and non-responders.