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Atossa Therapeutics and Quantum Leap Healthcare Collaborative Dose First Patient in I-SPY 2 Trial Combining (Z)-Endoxifen with Abemaciclib for ER+/HER2- Breast Cancer
SEATTLE, Aug. 21, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) and Quantum Leap Healthcare Collaborative™
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"SEATTLE, Aug. 21, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) and Quantum Leap Healthcare Collaborative™ (QLHC), today announced the first patient has been dosed in their clinical trial evaluating Atossa’s proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, as a neoadjuvant treatment in high-risk women with newly diagnosed Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in oncology with a focus on breast cancer. The study evaluating (Z)-endoxifen in combination with abemaciclib is part of the ongoing I-SPY 2 Endocrine Optimization Pilot Protocol (EOP), which focuses on patients with newly diagnosed estrogen receptor-positive (ER+) invasive breast cancer whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit. These patients have substantial risk for recurrence, often after five years, and need novel treatments that are more effective and tolerable than the current standard of care. The combination study, being conducted across the I-SPY network, will enroll approximately 80 participants across two 40-participant cohorts. Both cohorts will include pre-and-post menopausal women who will receive 80 mg (Z)-endoxifen once daily in combination with 150 mg abemaciclib twice daily for 24 weeks prior to surgery. Premenopausal women in the second cohort will also receive ovarian function suppression (OFS). The addition of OFS in premenopausal women enrolled in the second cohort of the study will assess the impact of OFS with this combination. Data from the study, anticipated in 2026, is expected to further validate the growing body of evidence that (Z)-endoxifen is safe and highly efficacious in both premenopausal and postmenopausal breast cancer patients. “Dosing the first patient in this trial marks a significant milestone for Atossa in support of our important partnership with the QLHC,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “The innovative idea of combining (Z)-endoxifen and abemaciclib in the neoadjuvant setting can open the door to the...