Oncternal Therapeutics Inc (NASDAQ: ONCT) is screaming for the top in the market this morning, and for good reason. The company announced updated interim clinical data from an ongoing Phase 1/2 clinical trial. Here’s what’s going on:
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ONCT Stock Pops On Interim Data
In the press release, Oncternal Therapeutics announced updated interim clinical data froman ongoing Phase 1/2 clinical trial. The trial, known as CIRLL, or Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and Lymphoma, is assessing an investigational anti-ROR1 monoclonal antibody, in combination with ibrutinib.
The combination treatment is being assessed as a potential option for patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). Importantly, the company isn’t footing the bill on the trial themselves either. In fact, ONCT reminded investors in the release that the trial is being partially funded by the California Institute for Regenerative Medicine.
In the release, the company said that 15 patients with relapsed or refractory MCL enrolled in the dose-finding and dose-expansion cohorts of the trial and were evaluable for efficacy. The data showed an improved overall best objective response rate, coming in at 87%, up over the previously reported 83%.
The complete response rate observed in the trial is 57%, generating a complete response in 7 of 12 evaluable patients for part 1 of the study. In Part 1 and Part 2, the complete response rate came in at 47%. Part 2 includes 3 patients with shorter follow up periods.
Importantly, all complete responses remain durable to date.
While ONCT said that progression-free survival was no reached, the data resulted in a 95% confidence interval above 17.5 months after the median follow-up of 12.1 months.
It’s also worth mentioning that all patients in the trial were heavily pretreated. In fact, patients received a median of two prior therapies prior to participation, 73% of which had undergone two or more prior lines of therapy. Also, four patients received prior treatment with ibrutinib and all four patients achieved clinical responses in this trial once ibrutinib was combined with irmtuzumab.
Moreover, as of the cut-off date, 56 evaluable patients were enrolled in the dose-finding, dose confirming, and randomized cohorts of the clinical trial with CCL. 49 of these patients have been treated with the cirmtuzumab and ibrutinib combination therapy.
92% of these patients, including one who achieved a complete response, achieved a clinical response. Moreover, four patients had stable disease with a total clinical benefit rate of 100%.
In a statement, Hun Ju Lee, M.D., Associate Professor of Medicine in the Department of Lymphoma & Myeloma at the University of Texas MD Anderson Cancer Center, and investigator on the trial, had the following to offer:
The interim data from the combination of cirmtuzumab and ibrutinib are quite promising in relapsed/refractory (r/r) MCL, with an impressive 87% best ORR that has improved over time. The time to response, depth and durability of responses make cirmtuzumab a compelling candidate for further development.
The above statement was followed up by James Breitmeyer, M.D., Ph.D., President and CEO at ONCT. Here’s what he had to say:
We are pleased that median PFS has not yet been reached after a median follow-up of over 12 months in the MCL patients, and are encouraged that both PFS and ORR have improved with longer follow-up. We are in active dialogue with FDA on pivotal study design in order to define the path to approval in MCL.
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This Is Big News
The news issued by Oncternal Therapeutics this morning proved to be overwhelmingly positive. Keep in mind, both MCL and CCL are very difficult-to-treat cancers. Fortunately, this clinical trial is showing incredible promise, setting the stage for a game-changing combination therapy to hit the market relatively soon.
Should all continue to go well, the company will be sitting on a goose that lays the golden eggs. Keep in mind, we’re talking about a company with a market cap of about $90 million that has the potential to tap into two multi-billion dollar markets. That’s a huge opportunity.
All in all, ONCT stock is one to watch closely.
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