Atossa Therapeutics and Quantum Leap Healthcare Announce I-SPY 2 Clinical Trial to Evaluate (Z)-Endoxifen in Combination with Abemaciclib (VERZENIO®) in Women with ER+/HER2- Breast Cancer

Core Insights - Atossa Therapeutics and Quantum Leap Healthcare Collaborative have initiated a study to evaluate the combination of (Z)-endoxifen and abemaciclib in women with ER+/HER2- breast cancer [1][2] - The study aims to enroll approximately 20 women with newly diagnosed invasive breast cancer, focusing on a neoadjuvant treatment approach [1][2] - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator (SERM) that has shown efficacy in patients resistant to other hormonal treatments [4][5] Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative oncology medicines, particularly for breast cancer [6] - The company is developing a proprietary oral formulation of (Z)-endoxifen that bypasses liver metabolism and stomach acidity to achieve therapeutic concentrations [5] - Atossa's (Z)-endoxifen is protected by three issued U.S. patents and numerous pending applications [5] Study Details - The new study is part of the ongoing I-SPY 2 Endocrine Optimization Pilot Protocol (EOP), targeting patients with ER+ invasive breast cancer who are at high risk for recurrence [2][8] - The study will assess the efficacy of (Z)-endoxifen in combination with abemaciclib, which is a CDK 4/6 inhibitor, to potentially enhance treatment outcomes [3][2] - Data presented at the AACR annual meeting indicated that (Z)-endoxifen can stop the growth of ER+ breast cancer and may shrink or eliminate tumors [3] Collaboration and Goals - Quantum Leap Healthcare Collaborative will conduct the study, with Atossa and Eli Lilly responsible for supplying their respective drugs [3] - The I-SPY TRIALs aim to rapidly screen promising treatments and identify effective options for specific patient subgroups based on molecular characteristics [8]