KangaBio's new generation IL-12 prodrug has been approved for IND application in the United States
Time：2023-10-26

On October 26th, KangaBio announced that its investigational new drug (IND) application for its first therapeutic product called "tumor-specific recombinant IL-12 Fc fusion protein for injection" (code: KGX101) has received formal approval for phase I clinical trials from the U.S. FDA. The company will conduct clinical trials for KGX101 as a monotherapy and in combination with anti-PD-L1 antibodies for late-stage solid tumors in both the United States and Australia with patient screening already initiated in several Australian clinical research centers.

KangaBio is a global clinical-stage biopharmaceutical company dedicated to discovering and developing novel tumor immunotherapies. It was founded in 2021 by Dr. Weidong Jiang, a seasoned professional in the pharmaceutical industry. The company aims to address unmet needs in the clinical treatment of cancer patients worldwide by developing next-generation immune stimulants and multi-specific antibodies based on innovative recombinant protein prodrug technology. Since its establishment just over two years ago, KangaBio has developed a strong product pipeline with multiple drug candidates and in June 2023, announced the successful completion of a pre-Series A financing round of around 15 million USD.

Dr. Weidong Jiang, Founder and CEO of KangaBio, stated, "We are very excited that KangaBio's first product, KGX101, has received clinical clearance from the FDA. Achieving this new milestone marks further recognition of our next-generation prodrug development platform and signals the beginning of global development of the company's innovative immune-oncology products. We look forward to benefiting immunotherapy-ineffective cancer patients with this highly promising product soon. This achievement would not have been possible without the recognition and support of our investors. We sincerely thank them for providing KangaBio with vital growth opportunities. I would also like to express our heartfelt gratitude to our employees for their outstanding contributions as well as our collaborators for their unwavering support. We look forward to introducing this highly promising innovative product to cancer patients in need in the near future."