Acknowledgement
3 business days
EA Therapies for Single Patient

Cosibelimab (also referred to as CK-301)

EA Policies for Single Patient

Checkpoint Therapeutics, Inc. (Checkpoint) is clinical-stage biotechnology company focused on accelerating the development and commercialization of potential life-changing oncology therapeutics. Checkpoint’s lead asset, cosibelimab (CK-301), is under clinical investigation for the potential treatment of solid tumor indications, and a biologics license application (BLA) for cosibelimab is currently under review with the US Food and Drug Administration for the potential approval of cosibelimab for advanced cutaneous squamous cell carcinoma. As clinical investigation of cosibelimab in solid tumors is ongoing, the preferred patient access pathway to cosibelimab treatment is via clinical trial participation. Information about cosibelimab clinical trials, including key eligibility criteria and clinical trial locations, is available at clinicaltrials.gov.
For access to cosibelimab treatment or other Checkpoint investigative therapies outside of ongoing clinical trials and prior to regulatory approval (eg, for patients who do not qualify for or are not able to participate in a current Checkpoint-sponsored clinical trial), Checkpoint will consider a physician’s request for access to a Checkpoint investigative therapy outside of the clinical trial setting. All such requests must be made in accordance with local laws and regulations and must be submitted by the treating physician to checkpointexpandedaccess@checkpointtx.com for Checkpoint’s review.