Iovance Biotherapeutics (NASDAQ:IOVA) said it has obtained clearance of an Investigational New Drug application for IOV-5001, extending its next-generation cell therapy platform into solid tumors the company said account for more than 100,000 US deaths a year.
The clearance allows Iovance to begin clinical work on IOV-5001 and marks the platform's move beyond its current focus and into the solid tumor setting.
The company framed the expansion around the size of the unmet need, pointing to the tens of thousands of annual US deaths in the targeted tumor types.
An IND clearance is the regulatory step that permits a company to start human testing of an experimental therapy in the United States. Carrying its next-generation platform into solid tumors widens the range of cancers Iovance's cell therapy approach could address and adds IOV-5001 to the programs the company is advancing toward the clinic.
Iovance did not detail the trial design or timing in the announcement.
Iovance Biotherapeutics is a commercial-stage biotechnology company developing cell therapies for the treatment of cancer.