On February 20, 2023 Biocity Biopharma reported that the US Food and Drug Administration (FDA) has granted its Investigational New Drug (IND) application for SC0191, a WEE1 inhibitor as monotherapy and in combination with chemotherapy for the treatment of cancer (Press release, Biocity Biopharmaceutics, FEB 20, 2023, View Source [SID1234633308]).

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"We are thrilled to have received IND approval for SC0191 as monotherapy and in combination with chemotherapy," said Yongjiang Hei, M.D., Ph.D., Co-CEO of Biocity "This is an important milestone for us, and we look forward to advancing SC0191 into clinical trials to assess its safety and efficacy in patients with cancer. We believe that the combination of SC0191 with chemotherapy has the potential to increase the response rate and duration of response in a variety of cancer types, and we look forward to seeing the results of our clinical trials."

The Phase 1/2 clinical trial of SC0191 will evaluate the safety, tolerability, and pharmacokinetics and preliminary anti-tumor effects of SC0191 as monotherapy and in combination with chemotherapy in patients with selected advanced or metastatic solid tumors. The trial is expected to begin enrolling patients in the near future, and Biocity is committed to conducting clinical trials with the highest standards of quality and patient safety.