Onconova Seeking FDA Approval for Phase 1 Trial of ON 123300 for Breast Cancer

Onconova Seeking FDA Approval for Phase 1 Trial of ON 123300 for Breast Cancer
Onconova Therapeutics is seeking the green light from the U.S. Food and Drug Administration (FDA) to begin a Phase 1 clinical trial for its small molecule ON 123300 in certain types of breast cancer. The trial would include, but not be limited to, people with relapsed/refractory advanced breast cancer, including those with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative HER2-) metastatic breast cancer who are resistant to approved second-generation CDK4/6 inhibitors. “Once the FDA approves our [investigational new drug application], we will seek Institutional Review Board approval at the site where this Phase 1 trial will be conducted. We anticipate the first patient to be enrolled during the first half of 2021,” Steven M. Fruchtman, MD, president and CEO of Onconova, said in a press release. ON 123300 is a small molecule that works as a dual selective inhibitor of the CDK4/6 and ARK5 proteins. When overactive, CDK4/6 can lead to unregulated proliferation of cancer cells, and ARK5 is known to promote the survival of tumor cells in a nutrient-deprived environment. In preclinical studies, ON 123300 was found capable of effectively killing cancer cells, rather than just slowing their proliferation, which is how currently marketed CDK inhibitors work. “We believe that ON 123300, based on its novel mechanism of action, presents an innovative approach to study advanced cancers including in HR+ HER 2- metastatic breast cancer that is or has become resistant to commercial CDK4/6 inhibitors," Fruchtman said. Enrolled participants will receive escalating doses of oral ON 123300, delivered daily at a starting dose at 40 mg, every 28 days, with the goal of assessing the therapy's safety, tolerability, and pharmacokinetic
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