Multifunctional Nanomedicine Developed Using Novel UChicago Tech Gets FDA Nod to Initiate Clinical Trials
Coordination Pharmaceuticals, Inc. (CPI) recently announced that the FDA has approved the company’s Investigational New Drug (IND) application to initiate a first-in-human Phase 1 clinical study of its novel cancer therapeutic in patients with advanced tumors.
The immuno-oncology company leverages a nanoscale coordination polymer (NCP) platform that was developed in the lab of James Franck Professor of Chemistry Wenbin Lin at the University of Chicago. The goal is to develop anticancer products that can address unmet medical needs and improve patient care.
“If you look at cancer therapies, very few treatments are single-agent – you hit [the cancer] with multiple therapies at the same time,” explained Lin, who is the founder and chairman of CPI. While this approach is today providing patients with improved outcomes, studies are necessary to determine the safety and efficacy of combining therapies.
“There’s really nothing like what we are developing… We are working on only-in-class candidates.”
– Wenbin Lin
As Lin explained, the proprietary NCP platform provides researchers with the ability to determine how a drug or combination of drugs will behave in patients. It also helps simplify dosing schedules and maximizes the synergy between drugs.
“[The platform] allows you to co-deliver multiple therapeutics that have very different physical and chemical properties that you normally can’t do,” Lin added.
By leveraging CPI’s proprietary nanoscale coordination polymer (NCP) platform, the company developed a novel antitumor nanomedicine – CPI-300 – which 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 blood-related toxicities. The acceptance and approval of the IND is an important milestone for the company, Lin said.
CPI is currently conducting Phase 1 studies of its other NCP candidates, CPI-100 and CPI-200. The company has been working with contract research organizations and clinical trials sites to run the studies and is in the process of designing the Phase 2 clinical trial protocol. “Everything is on track,” said Lin.
Additionally, CPI is underway with a Phase I study of RiMO-301, which uses a novel radiotherapy-radiodynamic therapy mode of action. “The platform allows you to enhance the therapeutic effect of radiotherapy, so you can lower radiation dose and get even better effects than with high dose radiation and reduce associated toxicity,” Lin explained. It also has shown the ability to activate the patient’s immune system and has “very strong synergy” with immune checkpoint inhibitors.
“Clinical readouts are coming back and will help us decide how to prioritize these different projects and focus resources on the most promising candidates,” said Lin, who has joint appointments at UChicago Medicine in the radiation and cellular oncology department.
“I have close ties with my colleagues at the School of Medicine,” he added. “We really are learning what types of clinical problems they are seeing and then go back and design chemistry to solve them.”
Lin talks to his colleagues who see patients every day and has been heavily involved with various initiatives in the oncology part of the school. “That really has been incredibly helpful to me in terms of knowing and learning what kinds of clinical problems that need urgent solutions and how we can retool chemistry to help them,” he explained.
CPI’s most recent step is among many in Lin’s career. “It’s been a long process,” he said. The founder of two companies – which today operate as CPI – Lin has been conducting research on developing cancer therapeutics and various platforms over the last 15 to 20 years.
“The most important asset we have is the two technology platforms that we licensed from the Polsky Center. These are things that nobody else is working on,” said Lin. “There’s really nothing like what we are developing,” said Lin. “People in pharma strive to develop first-in-class drugs. We are working on only-in-class candidates.”