On April 1, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that its corporate partner HanX Biopharmaceuticals has enrolled three patients in the second dosing cohort of its Phase 1 study with ON 123300 in HR+ HER2- metastatic breast cancer and other advanced relapsed/refractory cancers in China (Press release, Onconova, APR 1, 2021, View Source [SID1234577505]).

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The HanX trial has enrolled six patients to date in two cohorts and may continue to enroll patients with advanced relapsed/refractory cancer at increasing doses with three to six patients per dose until the recommended Phase 2 dose is identified. To date, patients have been dosed at the 40 mg and 80 mg dosage levels. HanX recently opened a third site, in Shanghai, for the conduct of the study.

"We are encouraged that the HanX Phase 1 study is proceeding as planned, and look forward to the identification of a recommended Phase 2 dose to move into later-stage trials. The third cohort in this trial with 120 mg of ON 123300 is expected to begin enrollment next; depending on the incidence of dose limiting toxicities, if any, at the 80 mg cohort," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova Therapeutics. "The HanX study trial design calls for dosing on days 1-21 of each 28-day cycle, compared with our planned Phase 1 study in the U.S. that will assess the safety, tolerability and pharmacokinetics of ON 123300 administered orally as monotherapy at increasing doses starting at 40 mg daily for continuous 28-day cycles. We are preparing to begin our U.S. study in the second quarter of 2021."

"ON 123300 is a multi-kinase inhibitor in addition to targeting CDK 4/6, which we believe presents an innovative approach to treating advanced cancers including HR+ HER2- metastatic breast cancer that is, or has become, resistant to commercial CDK 4/6 inhibitors. Beyond metastatic breast cancer, we believe ON 123300 may present an innovative approach to treating other cancers including mantle cell lymphoma, multiple myeloma, advanced colorectal cancer, hepatocellular carcinoma and inoperable glioblastoma," concluded Dr. Fruchtman.

In December 2017, Onconova entered into an agreement with HanX Biopharmaceuticals for the development, registration, and commercialization of ON 123300 in Greater China. The agreement included a licensing fee, future potential milestone payments, and royalties on sales. Onconova retains rights to ON 123300 in the rest of the world outside of Greater China.