On October 11, 2023 Allorion Therapeutics (Allorion), a clinical-stage biotechnology company dedicated to the discovery and development of next-generation targeted drugs for cancer and autoimmune diseases, reported the dosing of its first patient in the Phase 1/2 trial of ARTS-021 (NCT05867251) (Press release, Allorion Therapeutics, OCT 11, 2023, View Source [SID1234635865]). This open-label, first-in-human study is currently ongoing in the US and is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ARTS-021 in adult patients with advanced or metastatic solid tumors.
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ARTS-021 is a potent and highly selective CDK2 inhibitor formulated specifically for targeting HR+/HER2- breast cancers and CCNE1-amplified cancers. The objective is to enhance therapeutic efficacy and overcome resistance in these hard-to-treat cancer types. "Dosing the first patient with ARTS-021 marks a pivotal milestone given there remains an unmet need for highly selective CDK2 inhibitors," commented Greg Berk, MD, Chief Medical Officer of Allorion Therapeutics. "In 2023, nearly 300,000 new cases of HR-positive breast cancer were diagnosed and there remains very few treatment options. In addition, CCNE1 amplification, a frequently observed genetic alteration in human cancer, is present in 10 to 20% of ovarian cancer with no approved targeted therapies. With the advancement of the ARTS-021 program, there is potential for a transformative treatment that could notably enhance the lives of HR-positive breast cancer patients and those with CCNE1-amplified tumors."