#USA #Seattle #Breast Cancer #Atossa Therapeutics #Z-Endoxifen

Atossa Therapeutics Secures U.S. Patent for (Z)-Endoxifen

Atossa Therapeutics, Inc. has recently announced a monumental achievement in the field of biopharmaceuticals with the issuance of a new U.S. patent by the United States Patent and Trademark Office (USPTO). This patent specifically pertains to enteric oral formulations of (Z)-endoxifen, a promising therapeutic agent in the treatment of breast cancer and other hormone-dependent conditions. The patent, numbered 12,479,790 B2, encompasses a total of 100 claims directed towards highly purified forms of (Z)-endoxifen. This innovation includes methods for utilizing these formulations to treat various hormone-related breast disorders, thus broadening the potential treatment landscape.

Steven Quay, M.D., Ph.D., the President and CEO of Atossa Therapeutics, expressed optimism about the significance of this patent. He stated, "We believe this patent meaningfully extends and reinforces our already robust endoxifen patent estate." The newly acquired patent bolsters Atossa’s vision to establish (Z)-endoxifen as a preferred therapy across the spectrum of breast cancer treatment, which includes strategies for risk-reduction, neoadjuvant treatment, and addressing advanced or metastatic disease.

Dr. Quay also highlighted how this patent complements other previously issued patents that cover storage-stable and sustained-release formulations of (Z)-endoxifen. Together, these patents, including broader formulation patents granted earlier this year, establish Atossa's dominant position in the therapeutic market for endoxifen.

The Importance of (Z)-Endoxifen

(Z)-endoxifen is recognized as one of the most effective selective estrogen receptor modulators (SERMs) available. Its action mechanism includes inhibiting estrogen receptors and promoting their degradation, which is vital for effectively treating breast cancers that have become resistant to other hormonal therapies. The compound is designed to target PKCβ1, an oncogenic protein, making it a dual-function agent in managing hormone retention. Atossa is dedicated to refining the oral formulation of (Z)-endoxifen to maximize therapeutic benefits while minimizing adverse effects such as stomach discomfort.

The development of (Z)-endoxifen has progressed significantly, with clinical trials currently underway under critical indications:

• - Metastatic Breast Cancer (MBC): A dose-ranging study is in preparation to support the regulatory development required for this indication.
• - Neoadjuvant ER+/HER2- Breast Cancer: The Phase 2 EVANGELINE trial is actively enrolling participants and generating data.
• - Breast Cancer Risk-Reduction: The focus includes a low-dose strategy aimed at targeting mammographic breast density as a precursor to overall breast cancer risk reduction.

Strategic Implications

Atossa Therapeutics is not merely focused on this single patent but is building a comprehensive portfolio. The accumulation of multiple U.S. patents and global applications is designed to fortify long-term exclusivity for (Z)-endoxifen’s formulations, manufacturing processes, and critical therapeutic applications. Such strategic planning is essential as the company gears up for late-stage clinical trials and possible commercialization of its offerings.

The issuance of U.S. Patent No. 12,479,790 is a pivotal moment for Atossa Therapeutics, reaffirming its commitment to addressing significant unmet medical needs in breast cancer treatment. As they continue their research and development endeavors, this patent lays a foundation for innovative therapeutic solutions aimed at improving patient outcomes across the cancer care continuum.

In summary, Atossa Therapeutics stands at the forefront of biopharmaceutical innovation, with the new U.S. patent for (Z)-endoxifen reinforcing its position as a leader in transforming breast cancer treatment paradigms. With powerful therapies on the horizon, Atossa is set to make significant impacts for patients undergoing treatment for breast cancer and related hormonal conditions.