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    Cessation Therapeutics Receives FDA Fast Track Designation for CSX-1004 for Prevention of Fentanyl and Fentanyl Analog Overdose

    Details:

    CSX-1004 is a human IgG1 monoclonal antibody under phase 1 clinical studies, it is specific for fentanyl and fentanyl analogs and works by sequestering fentanyl molecules & effectively neutralizing them in the blood before they reach the brain.


    Lead Product(s): CSX-1004

    Therapeutic Area: Psychiatry/Psychology Product Name: CSX-1004

    Highest Development Status: Phase IProduct Type: Large molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 31, 2023

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

    Details:

    The funding will support development of a subcutaneous formulation of its anti-fentanyl monoclonal antibody, CSX-1004 SQ, an investigational product that has successfully entered Phase 1 studies for the reversal of acute opioid over dose of fentanyl and carfentanil drugs.


    Lead Product(s): CSX-1004

    Therapeutic Area: Psychiatry/Psychology Product Name: CSX-1004

    Highest Development Status: IND EnablingProduct Type: Large molecule

    Partner/Sponsor/Collaborator: National Institute on Drug Abuse

    Deal Size: $14.8 million Upfront Cash: Undisclosed

    Deal Type: Funding October 18, 2023

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    Cessation Therapeutics Announces Food and Drug Administration Authorization for First-in-Human Clinical Trial of Antibody for Prevention of Fentanyl Ove...

    Details:

    CSX-1004 is a recombinant human immunoglobulin G (IgG)1λ monoclonal antibody specific for fentanyl and related synthetic opioids. CSX-1004 is the first antibody-based therapy against fentanyl to gain IND approval.


    Lead Product(s): CSX-1004

    Therapeutic Area: Psychiatry/Psychology Product Name: CSX-1004

    Highest Development Status: IND EnablingProduct Type: Large molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 27, 2023

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    Cessation Therapeutics’ Anti-Fentanyl Monoclonal Antibody Treatment Shows Promise in Protecting Against Fentanyl-Induced Overdose

    Details:

    CSX-1004 is a human antibody that binds to fentanyl and related synthetic opioids tightly and with high-specificity. It has been demonstrated to provide multi-week protection from fentanyl overdose during animal studies.


    Lead Product(s): CSX-1004

    Therapeutic Area: Psychiatry/Psychology Product Name: CSX-1004

    Highest Development Status: IND EnablingProduct Type: Large molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 28, 2023

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