Atossa Therapeutics Secures Patent for (Z)-Endoxifen, Advancing Breast Cancer Treatment Options

Atossa Therapeutics Secures New Patent for (Z)-Endoxifen, Enhancing Cancer Treatment Prospects

Atossa Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to innovative therapies for breast cancer and hormone-driven conditions, announces the issuance of U.S. Patent No. 12,479,790 B2. This patent, granted by the United States Patent and Trademark Office, encompasses 100 claims related to enteric oral formulations of (Z)-endoxifen free base. Importantly, it also covers methods for utilizing these formulations in treating hormone-dependent breast disorders and other estrogen-related conditions. The patent includes specific solid oral dosage forms designed to ensure sustained systemic exposure to (Z)-endoxifen, a promising compound in the realm of breast cancer therapies.

According to Dr. Steven Quay, Atossa’s President and CEO, this newly acquired patent significantly enhances the company's existing intellectual property portfolio surrounding endoxifen. It supports Atossa's strategic goal of establishing (Z)-endoxifen as a differentiated treatment option across the spectrum of breast cancer—from risk-reduction strategies to neoadjuvant and metastatic disease management. With this patent in place, Atossa aims to solidify its position in a competitive market, ensuring long-term exclusivity for both the formulations and the manufacturing processes necessary for commercial success. As the company progresses in its late-stage clinical trials, the strength of its patent estate becomes increasingly crucial.

Atossa is actively advancing (Z)-endoxifen across various clinical settings, including a dose-ranging study for metastatic breast cancer and the ongoing Phase 2 EVANGELINE trial, which focuses on neoadjuvant ER+/HER2- breast cancer. Additionally, the company is exploring low-dose strategies for breast cancer risk-reduction. With multiple issued U.S. patents and pending applications worldwide, Atossa’s comprehensive intellectual property framework is designed to protect its innovative approaches, facilitating the potential commercialization of (Z)-endoxifen and reinforcing its commitment to improving treatment outcomes in hormone-driven cancers.

In a related development, Atossa Therapeutics also receives Rare Pediatric Disease (RPD) designation from the U.S. Food and Drug Administration (FDA) for (Z)-Endoxifen, aimed at treating Duchenne Muscular Dystrophy (DMD). This designation is significant for addressing serious conditions affecting individuals from birth to age 18 and may lead to a Priority Review Voucher (PRV) upon successful marketing application. This strategic milestone validates Atossa's efforts to provide better treatment options for DMD, and it underscores the company’s commitment to expanding its therapeutic portfolio beyond oncology into rare diseases.

Atossa's recent achievements not only bolster its position in breast cancer treatment but also highlight its innovative approach to addressing urgent needs in pediatric care. The combination of an enhanced patent estate and RPD designation positions Atossa favorably for future growth and development in both oncology and rare disease therapeutics.