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Let’s take a look at why Onconova Therapeutics, Inc. (ONTX) surged in the Postmarket hours

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Onconova Therapeutics, Inc. (NASDAQ: ONTX), shares rose above 37% to 0.586 in the post-‎market session today after the news that it has earned the U.S. Food and Drug ‎Administration (FDA) clearance for a Phase 1 analysis to continue with ON 123300, a ‎proprietary, differentiated, first-in-class multi-kinase inhibitor, under the Company’s ‎Investigational New Drug Application (IND).‎

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‎The Phase 1 study will be performed in the United States and will test the efficacy, safety ‎profile, and pharmacokinetics of orally administered ON 123300 as monotherapy at ‎elevated doses beginning at or beyond 40 mg daily for 28 consecutive days. Patients with ‎relapsed/refractory advanced cancer, including but not limited to HR+ HER2-metastatic ‎breast cancer patients with clinical resistance to licensed second-generation CDK4/6 ‎inhibitors, will be included in the study. Once the dose escalation step of the trial is finished ‎and the recommended Phase 2 dose is identified, additional HR+ HER2- postmenopausal ‎metastatic breast cancer patients immune to licensed second-generation CDK4/6 inhibitors ‎will be enrolled. Additional patient cohorts, including but not limited to patients diagnosed ‎with advanced colorectal cancer, and non-lymphoma, Hodgkin’s particularly mantle cell ‎lymphoma, are under consideration.‎


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The development of this U.S. The phase 1 experiment varies from the ongoing research ‎performed in China with ON 123300 by HanX Biopharmaceuticals, Inc., a partner of the ‎firm, which doses patients for 21 days every day. To date, four patients have been enrolled ‎in the HanX study, the second dosing cohort has been opened, and it is expected that ‎patients with advanced cancer will continue to be enrolled at two sites before the ‎recommended Phase 2 dose is identified. Notably, of the three currently approved inhibitors ‎of CDK4/6, two are approved for 21-day cycle dosing and one is approved for 28-day cycle ‎dosing. All three are blockbuster treatments sold by well-known pharmaceutical firms for ‎HR+ HER2-metastatic breast cancer, and all of these licensed therapies include concomitant ‎therapy with an aromatase inhibitor.‎

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