SC-101 has received Investigational New Drug (IND) approval from the U.S. Food and Drug

On May 31, 2024, Conjustar Biologics announced that its Nectin-4 targeting PDC drug SC-101 has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for evaluating the safety and efficacy of SC-101 alone or in combination with anti-PD-1 mAb in patients with advanced or metastatic solid tumors expressing Nectin-4.

Previously, SC-101 has received clinical trial approval in China and has started its clinical trial in January 2024, with the first patient enrolled in February 2024. SC-101 has demonstrated a good safety profile in its ongoing trial.

SC-101 is an innovative peptide-drug conjugate that specifically binds to tumor cells expressing Nectin-4, releasing a toxic payload to inhibit tumor growth.

Mr. Tang Shuyi, the President of Conjustar Biologics, stated “The FDA's approval of the IND application for SC-101 marks a new milestone in our development of innovative anti-tumor drugs. We will accelerate the clinical development of SC-101, aiming to provide more safe and effective treatment options for cancer patients worldwide."