In a May 20 research note, H.C. Wainwright & Co. analyst Ram Selvaraju reported and reviewed the data Oncternal Therapeutics Inc. (ONCT:NASDAQ) just released from two studies.
The first set of results comes from Oncternal's Phase 1/2 trial of cirmtuzumab + ibrutinib in mantle cell lymphoma (MCL) and lymphocytic leukemia. This combination "continues to deliver benefit in MCL," Selvaraju wrote, having now shown an 83% objective response rate and a 39% complete response rate in 18 relapsed or refractory MCL patients previously treated with a median of two therapeutics.
Selvaraju noted that after a median follow-up of 18.9 months, these study participants did not achieve median progression-free survival or median overall survival. However, he added, the benefit of the combination "appears favorable" given the results of a historical trial of only ibrutinib. That study, done in a similar population of 370 patients, demonstrated a 66% objective response rate, a 20% complete response and a 12.8-month median progression-free survival.
The second data set Oncternal just released is an update of results from the ongoing Phase 1/2 trial of TK216 + vincristine in Ewing sarcoma. These data show "consistent efficacy in a larger sample size," Selvaraju indicated. Specifically, at the recommended Phase 2 TK216 dose, 31 patients, with relapsed or refractory Ewing sarcoma and a median of three prior therapies, had a 9.7% objective response rate and a 1.8-month median progression-free survival.
"These results are consistent with what has been previously reported for TK216," wrote Selvaraju.
Given TK216's rare pediatric disease designation, Selvaraju pointed out, were the U.S. Food and Drug Administration to approve the therapeutic, Oncternal might be able to get a priority review voucher (PRV) for it.
"Receipt of a PRV upon approval of TK216 and successful sale of such an asset could constitute material upside to our forecasts," he added.
H.C. Wainwright maintains its Buy rating and $9 per share price target on Oncternal Therapeutics. Its current share price, in comparison, is about $5.56.
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