Solicitation for submission of Pre-LOIs for Cirtuvivint - Due May 19, 2023

April 28, 2023

As part of the cirtuvivint clinical development program, CTEP requests pre-solicitation applications from all interested UM1 investigators for selected studies. Cirtuvivint is a first-inclass selective oral inhibitor of CDC2-like kinases (CLKs) and dual specificity tyrosine phosphorylation-regulated kinases (DYRKs) that is under development by CTEP as an anticancer agent in collaboration with Biosplice Therapeutics. CLKs modulate the intracellular landscape of alternative splicing via phosphorylation of serine/arginine-rich splicing factors (SRSFs), which in turn regulate spliceosome assembly and pre-mRNA splice site selection. Abnormal pre-mRNA splicing represents a common oncogenic driver contributing to progression, migration, and drug resistance. DYRK1A can phosphorylate multiple targets involved in key cellular processes that have been associated with the hallmarks of cancer including proliferation, survival, cell cycle regulation, and the DNA damage response. Selective DYRK1A/B inhibitors have demonstrated preclinical efficacy in models of hematological malignancies.

If you are a DF/HCC Investigator interested in conducting a trial with cirtuvivint through the ETCTN, please fill out the attached Pre-LOI form and contact Dr. Geoffrey Shapiro ( to coordinate your submission to CTEP.

Submissions are due to CTEP May 19, 2023. The Investigational Drug Branch will review the submissions and make a formal request for a full LOI on or around June 16, 2023.

For more information please see the related documents below