Announcement of Availability to Investigators of Fianlimab (NSC 847987) and Cemiplimab (NSC 788843)
October 18, 2023
The Cancer Therapy Evaluation Program (CTEP) is accepting Letters of Intent (LOIs) to conduct clinical studies using fianlimab, a fully human monoclonal antibody targeting the immune checkpoint receptor LAG-3 on T cells, and cemiplimab, a fully human IgG4 anti-PD-1 antibody, which are being developed by CTEP as anticancer agents in collaboration with Regeneron. CTEP will also consider requests to supply fianlimab and cemiplimab for nonclinical studies. All clinical and nonclinical researchers possessing an interest in working with the agent are welcome to apply. Proposals for clinical trials should be supported by a strong rationale and robust preclinical data (see “Components of a Competitive Letter of Intent” at http://ctep.cancer.gov/protocolDevelopment/lois_concepts.htm).
All proposals approved by CTEP will be sent to the industry collaborator for approval and commitment to supply drug for the study.
If you are a DFHCC Investigator interested in submitting an LOI using fianlimab and cemiplimab through the ETCTN, please contact Dr. Geoffrey Shapiro (geoffrey_shapiro@dfci.harvard.edu)
Questions may be addressed to Dr. Cheryl Pickett (cheryl.pickett@nih.gov) Medical Officer, Investigational Drug Branch, CTEP, please CC Dr. Geoffrey Shapiro (geoffrey_shapiro@dfci.harvard.edu)
For more information please see the related documents below