A biopharmaceutical company with ties to UNC-Chapel Hill is preparing a crucial funding round prior to its first clinical trial.
The U.S. Food and Drug Administration recently approved Focal Medical's plans to initiate a phase 1b clinical study of the company's drug-device combination product. Focal, with offices in Cary, is developing a targeting therapeutic system that's intended to treat inoperable tumors by delivering chemotherapy drugs directly to the affected organs.
In its lead program, called ACT-IOP-003, Focal is targeting pancreatic cancer, the second leading cause of cancer-related deaths in the U.S. Through its system, the company believes it can deliver high concentrations of a chemotherapy drug, gemcitabine, directly to a patient's pancreas to reduce tumor volume to a point where surgical removal could be possible. Additionally, the company believes it can deliver these high concentrations while minimizing the side effects of chemotherapy.
Focal is aiming to initiate the study by the middle of 2024, said CEO Michael Aldridge. This marks an important milestone for the company, which was founded in 2015.
Focal is actively raising capital to support the work. The company aims to close a roughly $15 million funding round that will primarily include new, U.S.-based investors that have shown an interest in the company.
This would follow a previous $11.7 million Series A round that Focal completed in two tranches over multiple years. That round was led by Khosla Ventures, a venture capital firm in California.
Prior to the Series A round, Focal had raised seed funding from friends and family-type investors. The company has also received grants from the National Institutes of Health and National Cancer Institute, totaling about $7 million combined.
The company was founded by Jen Jen Yeh, a professor and surgeon at UNC-Chapel Hill and Joe DeSimone, a former UNC professor who is now at Stanford University. The company previously operated as Advanced Chemotherapy Technologies before changing its name in late 2022 to Focal.
Aldridge joined the company around the same time, after previously leading multiple biotech and pharma companies. While Aldridge is based in California, the rest of the company's employees — about a dozen — work at Focal's office in Cary. The company will likely bring on more employees as it raises capital, advances its clinical plans and expands its pipeline.
The company's second program targets oral cavity cancer. Aldridge said the company's system is a platform technology that, in addition to chemotherapy, could be useful in mRNA or gene editing.
