On June 8, 2021 Coordination Pharmaceuticals, Inc. (CPI), a privately held and clinical-stage biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application to initiate a first-in-human Phase 1 clinical study of CPI-300 in patients with advanced tumors (Press release, Coordination Pharmaceuticals, JUN 8, 2021, View Source [SID1234583729]).
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By leveraging CPI’s proprietary nanoscale coordination polymer (NCP) platform, CPI-300 selectively delivers two potent new chemical entities (NCEs) to tumors to achieve maximal antitumor efficacy. In preclinical studies, CPI-300 elicited prolonged tumor regression in multiple tumor models without any sign of hematological toxicities.
"FDA’s timely acceptance and approval of CPI-300 IND is an important milestone for the company. We are excited about the opportunity to study this NCP-based candidate in clinical trials," said Wenbin Lin, PhD, founder and chairman of CPI and also the James Franck Professor of Chemistry, Radiation & Cellular Oncology, and the Ludwig Center for Metastasis Research at the University of Chicago. "We anticipate that this study will generate important insights into the safety of CPI-300 and its preliminary therapeutic efficacy in cancer patients."
In addition, CPI is also conducting Phase 1 studies of CPI-100 and RiMO-301 on patients with advanced tumors. CPI-100 contains two synergistic NCEs for the activation of tumor-immune microenvironments, while RiMO-301 enhances antitumor effects of X-rays via a novel radiotherapy-radiodynamic therapy mode of action.
About the Studies
The Phase 1 study is a prospective, open-label, single arm, non-randomized study of CPI-300 in patients with advanced tumors. The primary objectives in the study include determining maximum tolerated dose (MTD), pharmacokinetics and preliminary antitumor activity of CPI-300. For additional clinical trial details, please refer to View Source;draw=2&rank=1.
For CPI-100 Phase I study: View Source;rank=1.
For RiMO-301 Phase I study: View Source;rank=1.