Cessation Therapeutics Awarded $14.8 Million Grant from the National Institute of Drug Abuse to Develop Novel Formulation of Anti-Fentanyl Monoclonal Antibody

Grant will fund Investigational New Drug enabling studies and manufacturing for CSX-1004 SQ

CHAPEL HILL, N.C.–(BUSINESS WIRE)–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.”

Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under award number UG3DA058544. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Cessation Therapeutics

Cessation Therapeutics is an early-stage pharmaceutical company working to develop novel immunobiologics designed to prevent and protect against overdose. With an initial focus on fentanyl, Cessation’s monoclonal antibodies can be adapted to target future synthetic opioids and other substances. Cessation has the potential to treat a range of substance use disorders and improve the lives of patients and families affected by the addiction crisis. Cessation was founded in 2018 by Mark Pearson and John D. Harkey, Jr., experienced, successful long-term biotech investors. Cessation has been financed through their investment firms Altamont Pharmaceutical Holdings, LLC and JDH Investment Management, LLC, respectively. For more information, please visit www.cessationtherapeutics.com.

About McLean Hospital

McLean Hospital has a continuous commitment to put people first in patient care, innovation and discovery, and shared knowledge related to mental health. It is consistently named the #1 freestanding psychiatric hospital in the United States by U.S. News & World Report, and is #1 in America for psychiatric care in 2023-24. McLean Hospital is the largest psychiatric affiliate of Harvard Medical School and a member of Mass General Brigham. To stay up to date on McLean, follow us on Facebook, YouTube, and LinkedIn.

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