Atossa Therapeutics Expands Endoxifen Patent Portfolio for Breast Cancer and Rare Disease Treatments

Atossa Therapeutics Strengthens Patent Portfolio for Endoxifen in Breast Cancer Treatment

Atossa Therapeutics, Inc. announces a significant advancement in its intellectual property landscape with the issuance of U.S. Patent No. 12,479,790 B2. This patent, awarded by the United States Patent and Trademark Office, covers 100 claims related to enteric oral formulations of highly pure (Z)-endoxifen free base. The patent focuses on innovative methods for utilizing these formulations to treat hormone-dependent breast disorders and other estrogen-related conditions. Specifically, it includes solid oral dosage forms designed to ensure sustained systemic exposure to (Z)-endoxifen, a key component in Atossa's strategy to offer differentiated treatments for various types of breast cancer.

The issuance of this patent significantly enhances Atossa's existing endoxifen patent estate, which already encompasses scalable manufacturing processes and therapeutic methods. According to Dr. Steven Quay, President and CEO of Atossa, this patent aligns with the company's strategic goal of positioning (Z)-endoxifen as a leading treatment option across the breast cancer spectrum. The focus ranges from risk-reduction strategies to neoadjuvant and metastatic disease management, which is crucial as Atossa advances its late-stage clinical trials and prepares for potential commercialization. This robust intellectual property foundation is vital in ensuring that Atossa can maintain a competitive edge in the biopharmaceutical industry.

Atossa is currently progressing with (Z)-endoxifen in several clinical settings, including a dose-ranging study for metastatic breast cancer (MBC) and the ongoing Phase 2 EVANGELINE trial for neoadjuvant ER+/HER2- breast cancer. The company is also exploring low-dose strategies aimed at reducing breast cancer risk. By solidifying its patent portfolio with multiple issued patents and applications worldwide, Atossa seeks to ensure long-term exclusivity for (Z)-endoxifen formulations and their therapeutic applications in breast cancer treatment, positioning itself as a leader in this critical area of women's health.

In another significant development, Atossa Therapeutics receives Rare Pediatric Disease designation from the U.S. Food and Drug Administration (FDA) for (Z)-Endoxifen, aimed at treating Duchenne Muscular Dystrophy (DMD). This designation, which applies to serious conditions affecting individuals from birth to age 18, could lead to eligibility for a Priority Review Voucher upon successful marketing application. Dr. Quay highlights this milestone as a validation of (Z)-Endoxifen's potential to address urgent treatment needs for families affected by DMD, setting Atossa on a path to broaden its therapeutic portfolio beyond oncology.

Janet Rea, Senior Vice President of Research and Development, notes that the RPD designation enhances Atossa's interaction with the FDA as they advance their clinical development path for DMD. The company eagerly anticipates progressing its (Z)-Endoxifen program to clinical trials, demonstrating Atossa's commitment to not only innovate in cancer therapies but also to address rare diseases, potentially generating additional value through participation in the Rare Pediatric Disease program.