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Atossa Therapeutics Announces Updated Protocol for Clinical Trial Evaluating (Z)-Endoxifen in Combination with Abemaciclib (VERZENIO®) in Women with ER+/HER2- Breast Cancer
SEATTLE, June 28, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced protocol changes in the
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"SEATTLE, June 28, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced protocol changes in the previously initiated study to evaluate Atossa’s proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company. The study is investigating the combination as a neoadjuvant treatment in 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 areas of significant unmet medical need in oncology with a focus on breast cancer. Based on accumulating data from the ongoing Phase 2 EVANGELINE study, the dose of (Z)-endoxifen in the combination study has been increased from 40 mg to 80 mg once daily. The change in study dose was determined following a review of safety, efficacy and pharmacokinetic (PK) data from participants currently enrolled in the 80 mg PK run-in cohort of the EVANGELINE study. The EVANGELINE study is enrolling premenopausal women with ER+/HER2- breast cancer. The study began with a 40 mg pharmacokinetic (PK) run-in cohort. Data from this cohort, which was presented at the 2024 American Association for Cancer Research (AACR) Annual Meeting, showed encouraging efficacy and an extremely favorable safety profile compared to currently approved endocrine therapies. Efficacy was measured by both reduction in Ki-67, a cellular marker for proliferation that indicates how fast the tumor is growing, and response (tumor shrinkage). Participants treated for a total of 24-weeks experienced an average reduction in Ki-67 of 92% and an average target lesion decrease of 37%. The study is now enrolling an 80 mg PK cohort, which is expected to deliver the optimal drug concentrations required to fully target PKCβ1 inhibition and further enhance (Z)-endoxifen’s antitumor efficacy. Additionally, the combination study will now enroll approximately 80 participants across two 40-participant cohorts. Both cohorts will include pre-and-menopausal women who will receive 80 mg (Z)-endoxifen once daily in combination with 150 mg abemaciclib twice daily for up to 24-weeks prior to surgery. Premenopausal women in the second cohort will also receive ova...