1. Atossa presented data on (Z)-endoxifen at SABCS 2025 for breast cancer. 2. Low-dose (Z)-endoxifen shows promise with high patient tolerability and efficacy. 3. Clinical trials indicate feasibility for active surveillance in low-risk DCIS patients. 4. (Z)-endoxifen effectively targets ESR1 mutations for breast cancer treatment. 5. EVANGELINE trial supports (Z)-endoxifen as a viable neoadjuvant therapy option.
FAQ
Why Bullish?
Positive clinical trial results and FDA trial support metrics enhance investor confidence.
How important is it?
The ongoing positive developments and promising data positions Atossa favorably in markets.
Why Short Term?
Immediate clinical trial results can spur momentum in stock price as they are released.
Atossa Therapeutics Reports Clinical Updates on (Z)-Endoxifen at SABCS 2025
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a pioneering clinical-stage biopharmaceutical firm focused on oncology, has presented four groundbreaking clinical trial updates on (Z)-endoxifen at the San Antonio Breast Cancer Symposium (SABCS), conducted from December 9-12, 2025, in San Antonio, TX. These findings may significantly enhance breast cancer treatment and risk reduction strategies.
Insights from SABCS 2025
"The updates presented at SABCS 2025 affirm the therapeutic promise of (Z)-endoxifen throughout the breast care continuum," stated Steven Quay, M.D., Ph.D., President and CEO of Atossa Therapeutics. He emphasized the importance of the company's expanding clinical evidence, aiming to further develop their high-value clinical programs, particularly within the Phase 2 EVANGELINE study targeting neoadjuvant ER+/HER2- breast cancer.
Key Findings from Clinical Trials
The following highlights are drawn from the recently presented trials:
- Initial Results from RECAST DCIS: A multicenter trial assessing active surveillance and new endocrine therapy agents for DCIS management.
- Low Dose (Z)-Endoxifen in I-SPY2 Endocrine Optimization Pilot: Demonstrating excellent tolerability and biological activity, suggesting its efficacy as a neoadjuvant endocrine therapy.
- Mechanisms of (Z)-Endoxifen Against ESR1 Mutants: Showing promise for treating patients with ER+/ESR1 mutant breast cancer.
- EVANGELINE Trial: A first-of-its-kind study investigating (Z)-endoxifen combined with ovarian function suppression for premenopausal women.
Clinical Trial Highlights
1. RECAST DCIS Outcomes
Early findings from the RECAST study highlight that short-term endocrine therapy paired with MRI response assessments can identify low-risk DCIS patients who can avoid invasive surgery. This approach may revolutionize treatment, creating a personalized care pathway.
2. I-SPY2 Low Dose (Z)-Endoxifen
The I-SPY2 pilot showcased low-dose (10 mg) (Z)-endoxifen's impressive tolerability, as 95% of participants completed at least 75% of the therapy. Significant reductions were observed in Ki-67 and MRI tumor volume, providing strong evidence for its potential in neoadjuvant therapy.
3. Effectiveness Against ESR1 Mutants
Research indicated that (Z)-endoxifen maintains effective antagonistic properties against key ESR1 mutations. This suggests a novel therapeutic strategy for patients with limited treatment options due to ESR1 mutations.
4. EVANGELINE Trial Overview
The EVANGELINE trial positions (Z)-endoxifen with ovarian function suppression as a viable alternative to traditional aromatase-inhibitor regimens. Early results indicate strong biologic activity, with 86% of participants achieving a significant Ki-67 response at week four.
About Atossa Therapeutics
Atossa Therapeutics, Inc. (Nasdaq: ATOS) concentrates on developing innovative oncology treatments addressing significant unmet needs. The company's main candidate, (Z)-endoxifen, is progressing across multiple clinical trials. With meticulous capital allocation, Atossa aims to prepare for future regulatory submissions and potential market introduction.
Forward-Looking Statements
This announcement contains "forward-looking statements" as defined by applicable laws. These statements encompass expectations concerning Atossa's regulatory strategies, potential indications for (Z)-endoxifen, and anticipated clinical milestones. Words such as "expect," "potential," and "may" signal forward-looking perspectives.
As the market awaits further clinical data, investors and healthcare professionals are urged to monitor Atossa Therapeutics’ progress and the implications of their innovative treatments.