World News: 22:01 GMT Wednesday 15th May 2019. [Oncternal Therapeutics via Globe Newswire via SPi World News]
SAN DIEGO, May 15, 2019 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc., a clinical-stage biotechnology company focused on developing potential first-in-class therapeutic candidates for cancers with critical unmet medical need, today announced that it will present interim data from an ongoing Phase 1/2 study of its investigational monoclonal antibody, cirmtuzumab, in combination with ibrutinib in patients with chronic lymphocytic leukemia (CLL), as part of a poster session at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 31 to June 4, 2019. The study is being conducted in collaboration with the California Institute for Regenerative Medicine (CIRM) and University of California San Diego (UC San Diego) School of Medicine.
Study CIRM-0001 is a Phase 1/2 clinical trial evaluating cirmtuzumab in combination with ibrutinib, and is actively enrolling patients with CLL and mantle cell lymphoma (MCL). Part 1 was a dose-finding arm designed to determine the recommended dosing regimen (RDR), Part 2 is an expansion cohort to confirm the RDR, and Part 3 will randomize patients with CLL to receive either ibrutinib alone or ibrutinib plus cirmtuzumab. There was a planned interim analysis of the dose finding component of Part 1, and the results included:
Receptor tyrosine kinase-like Orphan Receptor 1 (ROR1) is a survival factor for many cancers. Tumor cells that express ROR1 have tumor-initiating features that are associated with a dedifferentiated oncogenic state. When expressed by hematologic malignancies such as CLL and MCL, ROR1 acts as a receptor for the tumor growth factor Wnt5a. Researchers at UC San Diego School of Medicine discovered that targeting a critical epitope on ROR1 was the key to specifically targeting ROR1 expressing tumors, and this finding led to the discovery of the potent and highly selective antitumor activity of cirmtuzumab observed in preclinical studies. ROR1 activates pathways that lead to increased cancer cell proliferation, invasiveness and drug resistance. Oncternal believes ROR1 is an attractive target for cancer therapy because it is an oncofetal antigen – a protein not normally expressed in adults, and confers a survival and fitness advantage when reactivated and expressed by tumor cells. Overexpression of ROR1 in tumors results in cancer cells becoming less differentiated, increasing their ability to self-renew and metastasize by increasing cell migration and the ability to initiate new tumors. Patients with tumors that overexpress ROR1 have poor prognoses, consistent with the increased cell migration, tumor initiation, and chemotherapy resistance observed in preclinical models. When cirmtuzumab binds to ROR1, it blocks Wnt5a signaling, induces differentiation of the tumor cells, and inhibits tumor cell proliferation, migration and survival.
Globe Newswire: 22:01 GMT Wednesday 15th May 2019
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