Oncternal Therapeutics Announces Presentation of Clinical Data Update on Cirmtuzumab in Combination with Ibrutinib at 2019 ASH Annual Meeting - Seite 2

Cirmtuzumab as a single agent has been very well tolerated in this study. The combination of cirmtuzumab plus ibrutinib has also been well tolerated, with adverse events consistent with those reported for ibrutinib alone. There have been no dose limiting toxicities and no serious adverse events attributed to cirmtuzumab alone.

Genetic analysis of CLL cells from three patients showed pre-treatment transcriptome profiles associated with a stemness signature and NF-kB-driven inflammation. Both genetic signatures were reversed in these patients following cirmtuzumab treatment.

“It is exciting to see that cirmtuzumab in combination with ibrutinib continues to be well tolerated and has demonstrated 100% progression-free survival in patients with CLL, as well as encouraging early signals of efficacy in patients with MCL,” said Michael Choi, M.D., Associate Clinical Professor of Medicine in the Division of Hematology-Oncology at University of California San Diego School of Medicine, who is the lead investigator for the CIRLL clinical trial.

The CIRLL clinical trial is supported by a grant from the California Institute for Regenerative Medicine (CIRM) and is being conducted in collaboration with the UC San Diego School of Medicine.

“We are encouraged by the evidence of clinical activity and the safety data demonstrated by cirmtuzumab in the ongoing CIRLL clinical trial. We continue to be excited about its potential for the treatment of patients with ROR1-expressing cancers, including CLL, MCL, Her2-negative breast cancer and other solid tumors,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO.

About the CIRLL Clinical Trial

The CIRLL clinical trial (CIRM-0001) is a Phase 1/2 trial evaluating cirmtuzumab in combination with ibrutinib in separate groups of patients with chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL). Part 1 of the clinical trial was a Phase 1 dose-finding cohort designed to determine the Phase 2 dose, or recommended dosing regimen (RDR). Part 2 is a Phase 1b expansion cohort to confirm the RDR. Part 3 of the study, which is now open for enrollment, is a Phase 2 study in which approximately 90 patients with CLL will be randomized to receive either ibrutinib alone or ibrutinib plus cirmtuzumab, with a primary endpoint of complete response rate. Additional information about the CIRM-0001 clinical trial and other clinical trials of cirmtuzumab may be accessed at ClinicalTrials.gov.