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The latest news and publications from Cessation
Reversing a fentanyl overdose with naloxone
Medical examiner Dr. Steven Campman told 60 Minutes that more than two doses of naloxone, a life-saving drug that can reverse opioid overdoses, might be necessary to save the life of someone who has overdosed on fentanyl.
Fentanyl fueling worst drug crisis in U.S. history, killing 70,000 a year | 60 Minutes
Fentanyl, which is often hidden in counterfeit pills, is fueling the worst drug crisis in U.S. history. Last year the synthetic opioid killed more than 70,000 Americans.
Cessation Therapeutics Announces Oral Presentation of Preliminary Findings from First-in-Human Study of Anti-Fentanyl Monoclonal Antibody, CSX-1004
CHAPEL HILL, N.C.–(BUSINESS WIRE)–Cessation Therapeutics, Inc. (“Cessation”), a clinical-stage biotechnology company advancing biologics that target substances of abuse, today announced the presentation of preliminary data from its Phase 1a first-in-human study of CSX-1004, an investigational monoclonal antibody for prophylaxis against fentanyl-related overdose.
Could a monthly treatment prevent fentanyl overdoses? Scientists are working on it
Scientists have developed an antibody treatment that shows promise inblockingthe potentially deadly effects of fentanyl for nearly a month, raising hopes for a new tool to combat overdoses. Tests in animals found that the treatment could effectively block the effects of fentanyl, laying the groundwork for assessing whether the medication will prove effective in humans, according to a study published Tuesday in the journal Nature Communications.
Investigation of monoclonal antibody CSX-1004 for fentanyl overdose
The opioid crisis in the United States is primarily driven by the highly potent synthetic opioid fentanyl leading to >70,000 overdose deaths annually; thus, new therapies for fentanyl overdose are urgently needed. Here, we present the first clinic-ready, fully human monoclonal antibody CSX-1004 with picomolar affinity for fentanyl and related analogs. In mice CSX-1004 reverses fentanyl antinociception and the intractable respiratory depression caused by the ultrapotent opioid carfentanil.
Cessation Therapeutics Receives FDA Fast Track Designation for CSX-1004 for Prevention of Fentanyl and Fentanyl Analog Overdose
If approved, CSX-1004 would be the first FDA-approved therapy for prevention of fentanyl-related overdose– 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 the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CSX-1004, an investigational therapy for prevention of fentanyl-related overdose. 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.
Cessation Therapeutics Awarded $14.8 Million Grant from the National Institute of Drug Abuse to Develop Novel Formulation of Anti-Fentanyl Monoclonal Antibody
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.
Cessation Therapeutics Announces Food and Drug Administration Authorization for First-in-Human Clinical Trial of Antibody for Prevention of Fentanyl Overdose
CHAPEL HILL, N.C.–(BUSINESS WIRE)–Cessation Therapeutics, Inc., (“Cessation”) a clinical-stage biotechnology company advancing biologics that target substances of abuse, announced today that the U.S. Food and Drug Administration (FDA) has authorized the company to initiate a clinical trial in the U.S. for CSX-1004, a monoclonal antibody designed specifically to prevent fentanyl overdose.
Tens of Thousands of Americans are Dying Every Year from Fentanyl Overdose It’s time to fight fentanyl like the foe that it is
As a Navy admiral, I helped lead one of the most powerful militaries in the world. Today, our nation is fighting an urgent war right here at home. The opioid crisis in America has now become a fentanyl crisis. A synthetic opioid that is at least 50 times more potent than morphine, fentanyl is both exceedingly addictive and extraordinarily dangerous – just a few milligrams of it is enough to kill. And just as I once was on the frontlines of American conflicts around the world, my family and I are now on the frontlines of our nation’s war with fentanyl.
Cessation Therapeutics’ Anti-Fentanyl Monoclonal Antibody Treatment Shows Promise in Protecting Against Fentanyl-Induced Overdose
Single administration of treatment blocked life-threatening, fentanyl-induced respiratory depression in non-human primates for at least 3 weeks CHAPEL HILL, N.C.–(BUSINESS WIRE)–Cessation Therapeutics (“Cessation”), an early-stage biotechnology company focused on the development of novel immunobiologics for preventing and treating fentanyl overdose, today announced a new study demonstrating that its pioneering anti-fentanyl monoclonal antibody treatment, CSX-1004, may provide robust and durable protection from life-threatening respiratory depression caused by high doses of fentanyl. The findings come from the company’s ongoing series of proof-of-concept studies in non-human primates. Funded in part by a grant (U01DA051071) from the National Institute on Drug Abuse (NIDA) at the National Institutes of Health (NIH) through the Helping to End Addiction Long-term Initiative (NIH HEAL Initiative), the studies are designed to assess the antibody’s ability to block the respiratory depressant effect of fentanyl, the attribute of the drug that is ultimately the cause of death in an overdose scenario.
Cessation Therapeutics Featured in Article “Opioid Vaccines as a Tool to Stem Overdose Deaths”
Cessation Therapeutics, Inc, a preclinical stage biotechnology company focused on developing novel immunotherapeutics and small molecules to treat addiction, was featured in an article in TheScientist entitled “Opioid Vaccines as a Tool to Stem Overdose Deaths.” “Cessation Therapeutics, a California-based company founded in 2017 where Janda serves as scientific advisor and board member, is continuing to develop the combination heroin and fentanyl vaccine created by Janda’s group, says Cessation research and development director Paul Bremer, who is one of Janda’s former graduate students. But for now, the company is prioritizing an anti-fentanyl monoclonal antibody (mAb), an approach also being pursued by a handful of other groups, including Pravetoni’s. These antibodies are generated in the lab by giving animals an anti-fentanyl vaccine, and researchers involved in their development say the treatment has the potential not only to treat OUD and protect against overdose, but to reverse an overdose in progress. (See
Cessation Therapeutics’ Anti-Fentanyl Monoclonal Antibody Treatment Shows Promise in Protecting Against Fentanyl-Induced Overdose
CHAPEL HILL, N.C.–(BUSINESS WIRE)–Cessation Therapeutics (“Cessation”), an early-stage biotechnology company focused on the development of novel immunobiologics for preventing and treating fentanyl overdose, today announced a new study demonstrating that its pioneering anti-fentanyl monoclonal antibody treatment, CSX-1004, may provide robust and durable protection from life-threatening respiratory depression caused by high doses of fentanyl.