| Ticker | Status | Jurisdiction | Filing Date | CP Start | CP End | CP Loss | Deadline |
|---|
| Ticker | Case Name | Status | CP Start | CP End | Deadline | Settlement Amt |
|---|
| Ticker | Name | Date | Analyst Firm | Up/Down | Target ($) | Rating Change | Rating Current |
|---|
Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC, NASDAQ:CYCCP, ", , Cyclacel", , or the ", , Company", , ))))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced a publication in the journal Leukemia titled "Cyclin-dependent kinase inhibitor fadraciclib (CYC065) depletes anti-apoptotic protein and synergizes with venetoclax in primary chronic lymphocytic leukemia cells". Fadraciclib is Cyclacel's novel CDK2/9 inhibitor, currently in two Phase 1/2 trials, one for the treatment of advanced solid tumors and lymphomas and another for hematological malignancies, including patients with leukemia being treated in combination with venetoclax.
"Results from this research provide further mechanistic evidence in support of our ongoing Phase 1/2 clinical study of oral fadraciclib in select hematological malignancies," said Mark Kirschbaum, M.D., Senior Vice President and Chief Medical Officer of Cyclacel. "The findings confirmed that fadraciclib suppresses MCL1 and synergizes with venetoclax, the only FDA-approved apoptosis enabling leukemia treatment. We have included a cohort within the proof-of-concept part of our Phase 1/2 study that will evaluate the combination of fadraciclib plus venetoclax in patients who have previously failed venetoclax-based regimens."
Researchers from the Department of Experimental Therapeutics and the Department of Leukemia at The University of Texas MD Anderson Cancer Center published preclinical data interrogating fadraciclib's mechanism of action against primary cell lines of chronic lymphocytic leukemia (CLL), both as a single agent and in combination with the BCL2 antagonist, venetoclax.
Results from the study confirmed that fadraciclib inhibited CDK9 mediated transcription, reduced levels of the short-lived anti-apoptotic protein MCL1, and induced apoptosis in primary CLL cells. The data highlighted the importance of continuous treatment to prevent recovery of MCL1 protein levels. Fadraciclib is the only transcriptional CDK inhibitor in clinical development that is being dosed on a daily schedule by mouth.
Fadraciclib was shown to combine synergistically with venetoclax, the only FDA-approved apoptosis enabling, leukemia treatment. Furthermore, it was demonstrated that the best synergy, with fadraciclib and venetoclax given at the same time, was achieved in 17p deleted CLL cells, which were not sensitive to either agent alone.
Fadraciclib also overcame protection mediated by stroma CLL cells and lymph node microenvironment. This may be important for clinical translation as venetoclax appears to be less effective in the lymph nodes.1
The data support the rationale for pursuing clinical development of fadraciclib, either alone or in combination with a BCL2 antagonist, for the treatment of CLL.
