Oncternal Therapeutics Inc. (NASDAQ:ONCT) has provided a corporate update and released third-quarter 2020 results.
Oncternal to offer data updates for MCL, CLL, and Ewing sarcoma in Q4
The company’s CEO and President James Breitmeyer said that in Q3, they continued advancing their Oncology pipeline while strengthening their balance sheet. Breitmeyer said that the company expects to offer more data updates in clinical studies in patients with Ewing sarcoma, Mantle cell lymphoma, and chronic lymphocytic leukemia in Q4.
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Recently the company hosted a virtual scientific presentation on the current treatment setting of MCL plus a discussion of our cirmtuzumab MCL clinical data. An update of data from the ongoing open-label Phase 1/2 cirmtuzumba clinical study in combination with ibrutinib was presented at the 2020 Virtual ASCO meeting in May 2020. The data showed a 58% complete response rate and 83% overall objective response rate for patients with refractory/relapsed MCL as of the cut-off date of April 30, 2020. Cirmtuzumab is the company’s experimental, and potentially the first-in-class humanized monoclonal antibody, which binds with a high affinity to a biologically significant epitope on ROR1.
Oncternal Therapeutic seeking FDA approval for cirmtuzumab
In September 2020, the company met with the US FDA, and currently, it is in discussion with the FDA regarding accelerated approval for crimtuzumab in combination with ibrutinib in patients with refractory/relapsed MCL. Also, the company gave a data update from the open-label phase 1 clinical trial of TK216 in refractory/relapsed Ewing sarcoma patients as the ESMO Virtual Congress 2020.TK219 is an experimental potentially first-in-class, small-molecule inhibitor of the E26 transformation-specific family of oncoproteins. The presentation also included preliminary data for 15 patients treated at the recommended Phase 2 dose as of the data cut-off date of August 13, 2020. The 15 patients attained complete Responses, which includes a surgical CR with patients remaining on treatment.
The company will offer data updates for CLL and MCL patients treated with cirmtuzumab combined with ibrutinib in the ongoing phase 1/2 study at the ASH 2020 virtual annual meeting next month.