October 5, 2023

Allorion Therapeutics announces first patient dosed in phase1/2 study of ARTS-021, a potential best in class CDK2 inhibitor, for advanced or metastatic solid tumors

Allorion Therapeutics (Allorion), a clinical-stage biotechnology company dedicated to the discovery and development of next-generation targeted drugs for cancer and autoimmune diseases, announced today the dosing of its first patient in the Phase 1/2 trial of ARTS-021 (NCT05867251). 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.

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."

About Allorion Therapeutics

Allorion Therapeutics is a biotechnology company that focuses on creating new small molecule drugs for treating cancer and autoimmune diseases. The company has a team of experienced drug discovery and development professionals who identify new drugs with unique mechanisms of actions and develop innovative data and screening platforms for long-term success. Allorion Therapeutics aims to advance new drugs with high potential and clinical relevance.

About ARTS-021

ARTS-021 is a highly potent and selective inhibitor of CDK2, a key enzyme involved in cell cycle regulation. ARTS-021 can selectively inhibit the growth of tumor with CCNE1 amplification in preclinical studies. It can also overcome the resistance that ER+/HER2- breast cancer cells develop against CDK4/6 inhibitors.