NIDA awards $14.8M grant for development of anti-fentanyl monoclonal antibody

A clinical-stage biotechnology company has been awarded a multiyear grant totaling $14.8 million from the National Institute on Drug Abuse to develop a subcutaneous formulation of an anti-fentanyl monoclonal antibody.

According to a release from Cessation Therapeutics, the grant is part of a multiyear award given to the company as well as McLean Hospital, a member of Mass General Brigham.

CSX-1004 is a human IgG1 monoclonal antibody specific for fentanyl and fentanyl analogs, which works by neutralizing fentanyl molecules in the blood before they reach the brain, preventing them from causing harm. Cessation Therapeutics said in the release that it expects the new antibody platform to protect against overdose, reverse overdose and treat fentanyl-related opioid use disorder through a variety of methods.

The grant is expected to fund formulation, development and manufacturing of CSX-1004 as well as to evaluate its ability to attenuate the effects of fentanyl in preclinical models of fentanyl self-administration and relapse, per the release.

“We are grateful to NIDA for their continued support of Cessation’s anti-fentanyl development programs,” Andy Barrett, PhD, chief scientific officer at Cessation Therapeutics, said in the release. “This award to support a fixed-dose, subcutaneous formulation of CSX-1004 significantly catalyzes our IND-enabling efforts to develop a ready-to-use formulation that is tailored to patients’ needs in a broad range of health care settings.”