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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 · BioBuzz

By April 11, 2022News
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GERMANTOWN, Md., April 6, 2022 /PRNewswire/ — 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.

 

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