Onconova Therapeutics Announces The Initial Dosing Of The First Patient In The U.S. Phase 1 Clinical Trial Of ON 123300

Excerpt from the Press Release:

NEWTOWN, Pa., May 21, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced 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. 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.

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.

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