On May 21, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that the first patient has been dosed in the U.S. Phase 1 clinical trial of ON 123300, the Company’s proprietary, novel multi-kinase inhibitor (Press release, Onconova, MAY 21, 2021, View Source [SID1234580449]). The trial is expected to include three U.S. sites that will enroll patients with advanced cancer including, but not limited to, HR+ HER 2- metastatic breast cancer patients who are refractory to, or progressing on, currently approved CDK 4/6 inhibitors.

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The Phase 1 trial is designed to assess the safety, tolerability, and pharmacokinetics of ON 123300 administered orally as monotherapy at increasing doses starting at 40 mg daily for consecutive 28-day cycles. Following completion of the dose-escalation phase of the trial and once the recommended Phase 2 dose (RP2D) is established, additional patients with HR+ HER 2- metastatic breast cancer with at least one prior line of therapy, which are expected to include approved CDK 4/6 inhibitors, will be enrolled into the trial with the intent to identify signals of efficacy. Additional cancer indications are also under consideration for study, and will be chosen based on preclinical and developing data.

"We are excited to begin dosing patients in this Phase 1 study and are pleased to be advancing ON 123300’s clinical development in the United States," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova Therapeutics. "Our goal is to provide an innovative treatment option for patients with advanced breast cancer who have become resistant to the commercial CDK 4/6 inhibitors, and other refractory solid tumors driven by the overexpression of tyrosine kinases targeted by ON 123300. Notably, ON 123300’s ability to target multiple kinase pathways that are overexpressed in cancer may allow for single-agent efficacy and better tolerability compared to existing treatment regimens."

Dr. Fruchtman added, "We are also pleased by the progress our partner HanX Biopharmaceuticals is making with their ongoing Phase 1 trial with ON 123300 in China. While the administration schedule differs between these two Phase 1 trials, the maximum tolerated dose has not yet been reached in the first two dose-escalation cohorts of this trial, which is a promising sign for ON 123300’s safety profile. Collectively, we expect these two complementary Phase 1 studies to provide important insights that will inform the design of subsequent trials."

For more information on the U.S. Phase 1 clinical trial of ON 123300 see ClinicalTrials.gov identifier: NCT04739293.