Atossa Therapeutics, Inc and Quantum Leap Healthcare Collaborative, 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.
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“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 development of gentler more patient-friendly treatment options for women with invasive breast tumors. By combining these therapies, we hope to achieve improved outcomes compared to available therapies, not only in terms of safety and efficacy, but also with respect to patients’ quality of life outcome measures.”
“We are excited to announce that the first patient has been dosed in this clinical trial,” said Dr. Jo Chien, Professor of Medicine at UCSF and PI of the sub study. “Finding better options for patients with HR+ tumors that have high clinical risk and biology that does not respond well to chemotherapy and immunotherapy is an unmet need in the field. This study is addressing this need by exploring the potential of (Z)-endoxifen combined with abemaciclib in the pre-operative setting.”
Under the terms of the study agreement, QLHC will conduct the study with Atossa. Atossa and Eli Lilly and Company are each responsible for supplying their respective study drugs.
SOURCE: GlobeNewswire