- BiOneCure Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for BIO-106, a Novel TROP2 ADC for the Treatment of Advanced Solid Tumors
Germantown, MD, April 4th, 2022. BiOneCure Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the IND for BIO-106, an antibody-drug conjugate (ADC) designed to target TROP-2 to treat a broad range of advanced solid tumors.
The clinical study cleared by the FDA, known as StarBridge-1, is a Phase I/II, multicenter, open-label study to evaluate the safety, pharmacokinetics and preliminary anti-tumor activity of BIO-106 as monotherapy and in combination with pembrolizumab in patients with advanced cancers.
“This is the first IND approval for BiOneCure. It is a significant milestone for both our team and the patients we hope to serve.” said Haifeng Bao, Ph.D., Co-founder and Chief Executive Officer at BiOneCure. “BiOneCure has complete intellectual property rights of the product, covering the payload, antibody and the ADC drug product. The introduction of our innovatively developed ADC candidate BIO-106 validated our approach to the next generation of ADC. We are very excited to bring the new molecule to the clinical stage and look forward to advancing this trial.”
BIO-106 is an anti-Trop-2 ADC to target cancer cells expressing Trop-2, a protein overexpressed in a broad range of tumors including TNBC, HR+/HER2 mBC, NSCLC, and others. BiOneCure has developed BIO-106 using its proprietary TAMTM payload technology to enable homogenous high drug load. In the pre-clinical study, BIO-106 has demonstrated broad anti-tumor activities with excellent safety profile and wide therapeutic window.