Oncternal reports positive data from the combination of cirmtuzumab and ibrutinib in the ongoing Phase 1/2.
Shares of Oncternal Therapeutics, Inc. (ONCT) traded with a high volume on Monday following the presentation at the American Society of Hematology (ASH) 2020 Virtual Annual Meeting.
The stock rallied up to 80% trading at the day’s high of $4.87 up from the prior close of $2.66. ONCT shares rose from the session’s opening at $3.95 to $3.98, by the day’s close.
The trading volume was just above 77 million compared to the average volume of 2.6 million.
Oncternal is a clinical-stage biopharmaceutical firm that focuses on the development of novel oncology therapies. The company reported the interim clinical data of its ongoing study on Leukemia and Lymphoma.
During the ongoing Phase 1/2 CIRLL, Oncternal evaluated Cirmtuzumab and Ibrutinib and their combination in treating cancer patients including chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).
The Phase 1/2 CIRLL targets ROR1 to come up with an anti-ROR1 monoclonal antibody that helps the patients to recover from CCL and MCL. The combination of cirmtuzumab and ibrutinib was well tolerated. While, some adverse events were consistently reported for ibrutinib alone.
However, Oncternal recorded no dose-limiting toxicities and no unpleasant events ascribed to cirmtuzumab alone.
The Phase 1/2 CIRLL consisted of 15 patients with relapsed MCLand 56 evaluable patients with CLL, respectively. As of the data from Oct. 30, 2020, the data from both MCL and CLL was reported to be efficient in the dose-finding and dose-expansion cohorts.
Among the CLL study, 49 out of 56 patients were treated with a combination of cirmtuzumab and ibrutinib.
The ongoing Phase 1/2 clinical trial is partially funded by the California Institute for Regenerative Medicine.
The other key point evaluated from the study was that the data showed an impressive 87% best ORR in MCL which improved over time. Overall, the time response, depth and durability of responses give an extra edge to Oncternal’s cirmtuzumab. This makes it a compelling candidate for further development.
Thus far, the median PFS was not obtained in the MCL patients over the 12 months study period. The company believes that in the long-term progress both PFS and ORR will improve and provide encouraging results in the future.
While working on cirmtuzumab, Oncternal Therapeutics, Inc. (ONCT) is in active dialogues with the FDA. The company is discussing the pivotal study design with the FDA for paving way for the approval in MCL.