Grant will fund Investigational New Drug enabling studies and manufacturing for CSX-1004 SQ
The grant will fund a variety of activities, including the formulation, development, and manufacturing of CSX-1004 SQ. (Credit: Diana Polekhina on Unsplash)
Cessation Therapeutics, Inc. (“Cessation), a clinical-stage biotechnology company advancing biologics that target substances of abuse, today announced that it has been awarded an additional grant from the National Institute on Drug Abuse (NIDA, a division of the National Institutes of Health) to support development of a subcutaneous formulation of its anti-fentanyl mAb, CSX-1004 SQ. The new grant (UG3DA058544) is part of a multi-year award expected to total $14.8 million given to Cessation and McLean Hospital, a member of Mass General Brigham.
CSX-1004 is a human IgG1 monoclonal antibody specific for fentanyl and fentanyl analogs and works by sequestering fentanyl molecules as they enter the bloodstream, effectively neutralizing them in the blood before they reach the brain and preventing them from exerting their harmful effects. Through different delivery methods, the platform can be optimized to potentially protect against overdose, reverse overdose, and treat fentanyl-related opioid use disorder (OUD).
“We are grateful to NIDA for their continued support of Cessation’s anti-fentanyl development programs,” said Andy Barrett, PhD, Chief Scientific Officer at Cessation Therapeutics. “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 of CSX-1004 that is tailored to patients’ needs in a broad range of healthcare settings.”
The grant will fund a variety of activities, including the formulation, development, and manufacturing of CSX-1004 SQ and the evaluation of its ability to attenuate the effects of fentanyl in preclinical models of fentanyl self-administration and relapse. Funds from a prior grant (U01DA051071) from NIDA were utilized to conduct IND-enabling studies of CSX-1004 infusion, an investigational product that has successfully entered Phase 1 studies.
The award activities will be led by Co-Principal Investigators, Rajeev I. Desai, PhD (Director, Integrative Neurochemistry Laboratory at McLean Hospital and Assistant Professor of Psychiatry at Harvard Medical School) and Paul T. Bremer, PhD (Director, Research and Development, Cessation Therapeutics).
“Use of synthetic opioids, like fentanyl, is a rapidly intensifying public health problem with nearly 76,000 fentanyl-related overdose deaths in the US in 2022,” said Rajeev I. Desai, PhD. “Studies on current medications (e.g., buprenorphine, methadone, naltrexone) for opioid use disorder (OUD) show that the use of evidence-based treatments for managing OUD works but there is a need for novel medications to improve treatment retention and relapse rates in OUD. We are encouraged by our data showing that an antibody-based approach offers a highly promising therapeutic strategy for treating both fentanyl overdose and fentanyl-related OUD.”
Source: Company Press Release