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About Atossa Therapeutics Inc.
Atossa Therapeutics Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company dedicated to addressing significant unmet medical needs in oncology, with a primary focus on breast cancer treatment and prevention. Headquartered in Seattle, Washington, Atossa leverages cutting-edge science and proprietary technologies to develop innovative therapeutics that aim to improve patient outcomes and quality of life.
Core Business and Focus Areas
The company's flagship program centers on the development of (Z)-endoxifen, a potent and proprietary Selective Estrogen Receptor Modulator (SERM) designed to treat and prevent estrogen receptor-positive (ER+) breast cancer. Unlike traditional tamoxifen therapies, (Z)-endoxifen bypasses liver metabolism, achieving therapeutic concentrations more efficiently and reducing the risk of side effects. This innovative formulation is encapsulated to prevent degradation in the stomach, ensuring higher bioavailability and efficacy.
Atossa's pipeline also includes intraductal microcatheter technology, which enables the targeted delivery of therapies directly to the site of breast cancer. This approach is being explored for the administration of fulvestrant, immunotherapies, and chimeric antigen receptor (CAR) T-cell therapies, offering a potentially transformative method for localized treatment.
Clinical Trials and Research
Atossa is actively advancing multiple clinical trials to validate the safety and efficacy of its therapies. The company's Phase 2 EVANGELINE study focuses on premenopausal women with ER+/HER2- breast cancer, evaluating (Z)-endoxifen as a neoadjuvant treatment. Preliminary data has demonstrated significant tumor shrinkage, reduction in Ki-67 proliferation markers, and a favorable safety profile. Additional Phase 2 trials are investigating (Z)-endoxifen's impact on mammographic breast density and its potential in treating ductal carcinoma in situ (DCIS).
Collaborations with organizations like Eli Lilly and Quantum Leap Healthcare Collaborative further enhance Atossa's clinical capabilities, enabling the exploration of combination therapies such as (Z)-endoxifen with abemaciclib (a CDK 4/6 inhibitor) for high-risk breast cancer patients.
Intellectual Property and Competitive Positioning
Atossa's robust intellectual property portfolio includes multiple issued U.S. patents and numerous pending applications for (Z)-endoxifen and related technologies. This strong patent protection underscores the company's commitment to innovation and provides a competitive edge in the oncology therapeutics market.
Operating within the highly competitive biopharmaceutical industry, Atossa differentiates itself through its focus on targeted therapies, proprietary drug formulations, and patient-centric approaches. The company's emphasis on addressing gaps in current treatment paradigms positions it as a key player in the oncology space.
Market and Growth Potential
The global breast cancer therapeutics market continues to expand, driven by rising incidence rates and advancements in treatment options. Atossa's innovative pipeline addresses critical gaps in this market, particularly for patients with endocrine-resistant tumors or those seeking alternatives to chemotherapy. By focusing on both treatment and prevention, Atossa aims to capture a significant share of this growing market segment.
Challenges and Opportunities
As a clinical-stage company, Atossa faces challenges typical of the biopharmaceutical sector, including high R&D costs, regulatory hurdles, and the need for successful clinical trial outcomes. However, its strategic partnerships, strong intellectual property position, and focus on unmet medical needs provide a solid foundation for long-term growth and success.
Conclusion
Atossa Therapeutics Inc. exemplifies innovation and dedication in the fight against breast cancer. Through its proprietary (Z)-endoxifen and advanced delivery technologies, the company is poised to make a meaningful impact on oncology therapeutics. With a strong clinical pipeline, strategic collaborations, and robust intellectual property, Atossa is well-positioned to address significant unmet medical needs and drive advancements in breast cancer treatment and prevention.
Atossa Therapeutics (Nasdaq: ATOS) announces that board director Dr. Tessa Cigler and Weill Cornell Medicine have been awarded a $2.3 million CDC grant over five years. The grant aims to improve breast cancer care for young patients across New York City, focusing on equitable access, quality of life, and survival outcomes.
Dr. Cigler, who serves as Associate Professor of Clinical Medicine at Weill Cornell Medicine and co-principal investigator, will collaborate with Dr. Vered Stearns to enhance care coordination and provide culturally relevant resources. The initiative specifically targets patients from diverse racial, ethnic, and socio-economic backgrounds, implementing interventions to optimize physical, emotional, and mental well-being for both patients and caregivers.
Atossa Therapeutics (Nasdaq: ATOS) has responded to the Patent Trial and Appeal Board's (PTAB) final decision regarding U.S. Patent No. 11,572,334, which found all challenged claims unpatentable. While disappointed, the company states this ruling does not affect their current clinical development formulations.
Rather than pursuing an appeal due to time and cost considerations, Atossa will seek patent protection through a new Continuation Patent Application. The company also announced the issuance of a new patent (U.S. Patent No. 12,201,591) on January 21, 2025, for sustained release compositions of endoxifen.
Atossa's current patent portfolio includes multiple U.S. patents with numerous claims: No. 11,261,151 (21 claims), No. 11,680,036 (22 claims), No. 12,071,391 (44 claims), and the new No. 12,201,591 (31 claims), all covering their clinical development formulations.
Atossa Therapeutics (NASDAQ: ATOS) has released a shareholder letter highlighting significant progress in 2024 for their breast cancer prevention and treatment programs. The company completed the KARISMA-Endoxifen Phase 2 Study, which demonstrated significant reductions in mammographic breast density of 17.3% (1mg) and 23.5% (2mg) compared to placebo.
The EVANGELINE trial showed promising results in its pharmacokinetic run-in phase, with 50% of patients receiving 80mg (Z)-endoxifen with goserelin reaching target steady-state plasma concentrations. The I-SPY 2 Endocrine Optimization Pilot demonstrated 95% treatment compliance, with a 69% reduction in Ki-67 and 30.4% reduction in functional tumor volume after three weeks.
The company secured two additional U.S. patents for (Z)-endoxifen and maintains a strong financial position. For 2025, Atossa plans to focus on advancing (Z)-endoxifen into registrational trials and expanding global business development efforts.
Atossa Therapeutics (NASDAQ: ATOS) endorses the U.S. Surgeon General's Advisory highlighting alcohol as a major preventable cause of breast cancer. The Advisory reveals that alcohol contributes to nearly 100,000 cancer cases and 20,000 cancer deaths annually in the US, making it the third leading preventable cause of cancer after tobacco and obesity.
Breast cancer represents the largest portion of alcohol-related cancers in women, accounting for 44,180 cases annually (16.4% of all breast cancer diagnoses). The risk begins to rise with as little as one drink per day, yet less than 45% of Americans believe alcohol significantly affects cancer development.
The Advisory calls for updated health warning labels on alcoholic beverages, expanded public education efforts, and implementation of proven alcohol reduction strategies in cancer prevention initiatives.
Atossa Therapeutics (NASDAQ: ATOS) has announced groundbreaking research findings on compounds that work synergistically with (Z)-endoxifen for breast cancer treatment. The discovery, presented at the 2024 San Antonio Breast Cancer Symposium, utilized both insilico and chemical screening approaches to identify compounds that target specific enzymes and proteins involved in tumor survival.
The research demonstrated that combinations of these newly discovered compounds with (Z)-endoxifen induced enhanced cell death in MCF-7 breast cancer cells, particularly when using inhibitors of MEK, PI3K, and AKT. The findings suggest promising potential for combination therapies targeting topoisomerase, CDK, mTOR/PI3K, and AKT alongside (Z)-endoxifen, though further research is needed.
Atossa Therapeutics (NASDAQ: ATOS) announced full results from its Phase 2 KARISMA-Endoxifen trial, showing significant reductions in mammographic breast density (MBD) in premenopausal women. The randomized, double-blind study of 240 women aged 40-55 tested 1mg and 2mg doses of (Z)-endoxifen against placebo over six months.
The 1mg dose reduced MBD by 17.3 percentage points and the 2mg dose by 23.5 percentage points (both p<0.01), compared to 0.27 points for placebo. The 1mg dose showed no significant difference in adverse events versus placebo, while the 2mg dose had higher rates of side effects. Plasma concentrations were 4.8 ng/mL and 9.7 ng/mL for 1mg and 2mg doses respectively.
Atossa Therapeutics (ATOS) presented pharmacokinetic and tolerability data from its Phase 2 EVANGELINE trial at SABCS 2024. The trial investigates (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with ER+/HER2-negative breast cancer. Key findings include: 50% of patients receiving 80mg (Z)-endoxifen with goserelin met target steady-state plasma concentrations, while 38% reached target levels without goserelin. The 80mg dose achieved tissue levels double that of plasma levels in 90% of patients.
The treatment showed substantial tumor suppression across all dosing levels, with Ki-67 response rates above 85%. Quality of life data indicated the treatment was generally well-tolerated. Based on these results, EVANGELINE will proceed with an amended protocol comparing 40mg/day (Z)-endoxifen plus OFS to exemestane plus OFS, with recruitment expected to begin in 2025.
Atossa Therapeutics (NASDAQ: ATOS) presented research on the anti-cancer activity of (Z)-endoxifen and its byproducts at the AACR Special Conference. The study investigated four (Z)-endoxifen byproducts for treating estrogen receptor-positive (ERα+) breast cancer, including endocrine-resistant tumors.
Two compounds, AT416E and AT402E, showed strong anti-proliferative activity, with AT416E demonstrating enhanced inhibition of cell migration and invasion. All four byproducts exhibited greater anti-proliferative effects than (Z)-endoxifen in estrogen-deficient conditions, while (Z)-endoxifen proved most effective at inducing cell cycle arrest and apoptosis.
The company plans future in vivo studies to validate these compounds' potential in overcoming current endocrine therapy limitations.
Atossa Therapeutics (NASDAQ: ATOS) announced its upcoming presentation at the AACR Special Conference in Cancer Research in Toronto, December 9-11, 2024. The company will present a poster titled 'Anti-cancer Activity of (Z)-Endoxifen-Related Compounds in ERα+ Breast Cancer' on December 10, 2024.
The research focuses on optimizing therapeutic efficacy and tolerability through modifications to (Z)-endoxifen chemistry in treating estrogen receptor alpha-positive breast cancer. The presentation aims to demonstrate how these compounds could enhance potency and reduce adverse effects in cancer treatment outcomes.
Atossa Therapeutics (ATOS) announced that five abstracts featuring data on (Z)-endoxifen have been accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS) in December 2024. The presentations will showcase findings from various studies evaluating (Z)-endoxifen in breast cancer prevention and treatment, including phase 2 trials and combination therapy research. Key presentations include studies on breast cancer prevention, quality of life outcomes in premenopausal patients, pharmacokinetic profiles, synergistic treatment combinations, and a non-inferiority trial comparing (Z)-endoxifen to existing treatments.
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