Oncternal Therapeutics (ONCT) Stock: Over 9% Increase Pre-Market Explanation

By Amit Chowdhry ● May 20, 2021
  • The stock price of Oncternal Therapeutics Inc (NASDAQ: ONCT) increased by over 9% pre-market. This is why it happened.

The stock price of Oncternal Therapeutics Inc (NASDAQ: ONCT) – a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies – increased by over 9% pre-market. Investors are responding positively to the company announcing updated interim clinical data from the oral presentation on its ongoing Phase 1/2 clinical trial evaluating TK216 — which is an investigational, potentially first-in-class, targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins — in patients with relapsed or refractory Ewing sarcoma, to be presented at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting.

Ravin Ratan, M.D., Assistant Professor, Department of Sarcoma Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, will be presenting at the ASCO 2021 Annual Meeting Sarcoma oral session that 2 heavily pre-treated and metastatic Ewing sarcoma patients treated at the recommended Phase 2 dose (RP2D) of TK216 continue to demonstrate prolonged complete regression of Ewing sarcoma for greater than one and two-years on study and have tolerated ongoing treatments well with TK216 alone or in combination with vincristine.

The data will be presented at the ASCO 2021 Annual Meeting:

— Abstract Title: TK216 for Relapsed/Refractory Ewing Sarcoma: Interim Phase 1/2 Results

— Abstract number: 11500

— Session Title: Sarcoma

— Session Date and Time: June 4, 2021, from 1:30 – 4:30 p.m. (Eastern Time)
As of the April 16, 2021 data cut-off date, a total of 68 patients with relapsed/refractory Ewing sarcoma were treated with TK216 in study TK216-01, 29 patients in the dose-finding cohorts, and 39 patients treated at the RP2D of TK216 (200 mg/m2/day for 14 days) with vincristine 0.75-1.5 mg/m2 administered on the first day of each cycle. And all patients treated at the RP2D had metastases at study entry and were heavily pretreated, with a median number of three prior systemic therapies (range 1-8). 

Two of the patients treated at the RP2D have achieved marked and sustained regression in target lesions after as little as two cycles of therapy. The first patient experienced 100% regression of target lesions following two cycles of TK216 alone. 

And after 6 cycles of treatment that included concomitant vincristine starting in the third cycle, a single 7 mm non-target lung lesion was resected, resulting in a surgical complete remission. The patient remained on study with no evidence of disease after more than 24 months. The second patient had attained 90% resolution of target lung lesions following two cycles of TK216 plus vincristine, then achieved a CR after six cycles of therapy. 

This patient also remained on study disease-free after more than 14 months, treated with TK216 alone following cycle 5. And at the RP2D, the objective response rate (ORR) was 9.7% (3 of 31 evaluable patients), including one patient with an unconfirmed partial response (PR). Eleven patients (35.5%) had stable disease (SD), for a disease control rate (CR, PR, SD) of 45.2% (14 of 31 evaluable patients).

The median progression-free survival (PFS) for patients treated at the RP2D was 1.9 months (95% CI: 1.5, 3.0), with an encouraging tail of extended PFS for some patients. And the updated safety data showed that TK216 at the RP2D has been generally well tolerated, with frequent side effects including myelosuppression, fatigue, and alopecia. No unexpected off-target toxicities or deaths related to TK216 toxicity were observed.

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