A biotech in Chapel Hill has landed funding from the federal government to support its efforts in addressing the ongoing fentanyl crisis.
With the support of a grant worth $14.8 million, Cessation Therapeutics will work with a hospital in Massachusetts to develop a new formulation of the company's monoclonal antibody as a potential treatment for fentanyl overdose and fentanyl-related opioid use disorder.
Cessation is already pursuing this monoclonal antibody as an IV infusion in a phase 1 study that recently launched. With this grant, the company aims to build on this program and develop the same monoclonal antibody as a subcutaneous injection.
This formulation of the monoclonal antibody, CSX-1004, has the potential to reach more patients and create a larger market opportunity for the company. While Cessation's infusion program could be administered to patients in hospital settings or infusion clinics, the injection could be delivered in a broader array of health care settings, said CEO Tracy Woody.
"We want this drug to be as accessible to as many people as possible," Woody said.
Because the company has already advanced one formulation of its monoclonal antibody to a phase 1 study, the preclinical work on this second program will be accelerated, said Chief Scientific Officer Andy Barrett. With the support of this grant, Cessation plans to complete the work needed to file an investigational new drug application with the U.S. Food and Drug Administration by the end of 2024, paving the way for the program to move into the clinic.
Cessation is completing this work alongside McLean Hospital, a psychiatric hospital affiliated with Harvard Medical School and a member of Mass General Brigham. This is the continuation of a years-long collaboration between the two organizations, which began with the development of the first formulation of CSX-1004.
That initial work was supported by a grant from the National Institute on Drug Abuse — part of the National Institutes of Health — worth more than $7 million. The federal agency is again supporting Cessation's efforts through the new, multi-year grant.
Cessation has previously raised about $8 million from private sources, including investors Altamont Pharmaceutical Holdings and JDH Investment Management, plus family offices.
This recent grant funding will help jumpstart Cessation's subcutaneous injection program, but it doesn't replace the company's plans for a Series A round, Woody said. The company is in the process of talking with investors with the aim of using the Series A funds to support its clinical development plans.
The funding will help the biotech reach valuable inflection points at a faster rate, Woody said. These events, like the company completing IND-enabling studies, could give investors confidence around the technology Cessation is advancing.
"For a space (addiction) where there's not a lot of investment, people want to see those milestones hit," Woody said. "And this gets us to those milestones at a speedier rate."
