FDA Grants Coordination Pharmaceuticals IND Approval for CPI-300, a Novel Antitumor Nanomedicine

Coordination Pharmaceuticals, Inc. (CPI), a privately held and clinical-stage biopharmaceutical company, announced today 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.

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 https://clinicaltrials.gov/ct2/show/NCT04808453?term=NCT04808453&draw=2&rank=1.

For CPI-100 Phase I study: https://clinicaltrials.gov/ct2/show/NCT03781362?term=NCT03781362&rank=1.

For RiMO-301 Phase I study: https://clinicaltrials.gov/ct2/show/NCT03444714?term=NCT03444714&rank=1.

About Coordination Pharmaceuticals, Inc.

Coordination Pharmaceuticals, Inc. (CPI) is a privately held oncology drug development company that aims to address unmet medical needs and improve patient care. Its NCP technology is in-licensed from the University of Chicago with worldwide rights in development and commercialization. For more information, please visit our website at www.coordinationpharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding CPI's expectations and beliefs about the potential benefits of CPI's product candidates, the plans and timelines for the clinical development and the benefit of its strategic plans and focus. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from CPI's current expectations and beliefs. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other important factors including but not limited to CPI's results of clinical trials; the content and timing of decisions made by the U.S. FDA and other regulatory authorities; CPI's ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials; unplanned cash requirements and expenditures; competitive factors; CPI's ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing. Any forward-looking statements contained in this press release speak only as of the date hereof, and CPI expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Media Contact: Dr. Wenbin Lin, lin@coordinationpharma.com

Source: Coordination Pharmaceuticals, Inc.