Atossa Therapeutics and Quantum Leap Healthcare Announce I-SPY 2 Clinical Trial to Evaluate (Z)-Endoxifen in Combination with Abemaciclib (VERZENIO) in Women with ER+/HER2- Breast Cancer - Seite 2

“Data recently presented at the American Association for Cancer Research (AACR) annual meeting was extremely encouraging as it shows that (Z)-endoxifen can not only stop ER+ breast cancer from growing, but it can also shrink or eliminate the tumor, as measured by MRI imaging,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Combining this activity with a targeted therapy like CDK 4/6 inhibition, which interrupts the process through which breast cancer cells divide and multiply, has the potential to deliver efficacy beyond the sum of the two monotherapies. We look forward to seeing the results of this study as it will help us better understand which patients are best suited for mono vs. combination therapy in the neoadjuvant setting. It will also inform plans to potentially explore this combination in the advanced-stage and metastatic breast cancer settings.”

Under the terms of the study agreement, Quantum Leap will conduct the study with Atossa and Eli Lilly and Company each responsible for supplying their respective study drugs.

About (Z)-Endoxifen
(Z)-endoxifen is the most potent Selective Estrogen Receptor Modulator (SERM) for estrogen receptor inhibition and also causes estrogen receptor degradation. It has also been shown to have efficacy in the setting of patients with tumor resistance to other hormonal treatments. In addition to its potent anti-estrogen effects, (Z)-endoxifen has been shown to target PKCβ1, a known oncogenic protein, at clinically attainable blood concentrations. Finally, (Z)-endoxifen appears to deliver similar or even greater bone agonistic effects while resulting in little or no endometrial proliferative effects compared with standard treatments, like tamoxifen.

Atossa is developing a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach, as acidic conditions in the stomach convert a significant proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s (Z)-endoxifen has been shown to be well tolerated in Phase 1 studies and in a small Phase 2 study of women with breast cancer. (Z)-endoxifen is currently being studied in four Phase 2 trials: one in healthy women with measurable breast density, one in women diagnosed with ductal carcinoma in situ, and two other studies including the EVANGELINE study in women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by three issued U.S. patents and numerous pending patent applications.