Welcome to our dedicated page for Atossa Therapeutics news (Ticker: ATOS), a resource for investors and traders seeking the latest updates and insights on Atossa Therapeutics stock.
Overview
Atossa Therapeutics Inc (ATOS) is a clinical stage biopharmaceutical company that develops and markets innovative medicines, laboratory tests, and therapeutic delivery platforms focused on addressing unmet medical needs in oncology. With a primary emphasis on women’s breast health and breast cancer, the company is dedicated to advancing novel drug candidates and precision-targeted delivery systems, employing cutting-edge approaches such as selective estrogen receptor modulation and intraductal microcatheter technology.
Core Therapeutic Focus
The company’s flagship asset, (Z)-endoxifen, exemplifies its commitment to tackling critical challenges in breast cancer treatment. (Z)-endoxifen is a potent selective estrogen receptor modulator (SERM) that not only inhibits estrogen receptor activity but also facilitates its degradation. This dual action is strategically designed to address cases where resistance to traditional hormonal therapies exists, thus filling a significant therapeutic gap in oncology. Additionally, the formulation of (Z)-endoxifen is developed as an oral medication that bypasses the liver metabolism and gastric degradation issues, ensuring optimal bioavailability at therapeutic concentrations.
Innovative Drug Delivery Platforms
Beyond its core drug candidates, Atossa Therapeutics is also pioneering advanced delivery mechanisms to enhance therapeutic efficacy. The development of intraductal microcatheter technology represents a novel approach to deliver therapies directly to the site of breast cancer, thereby improving the targeting of treatments such as hormonal therapies, immunotherapies, and chimeric antigen receptor T-cell therapies. This targeted delivery strategy not only heightens the precision of treatment but also has the potential to reduce systemic side effects, contributing to an overall improved patient experience.
Clinical Development and Research Programs
Atossa’s development pipeline is robust, with multiple Phase 2 trials designed to evaluate the effectiveness of (Z)-endoxifen in diverse patient populations, including women with measurable breast density and those diagnosed with ductal carcinoma in situ. The company’s research initiatives extend to combination therapies, where (Z)-endoxifen is studied alongside other agents such as cyclin-dependent kinase (CDK) inhibitors, further broadening the therapeutic paradigm in breast cancer treatment. These programs underscore the company’s strategic emphasis on targeted oncology, employing rigorous clinical methods to substantiate the efficacy and safety of its novel therapies.
Intellectual Property and Market Position
Central to Atossa’s strategy is its strong intellectual property portfolio, which includes multiple issued U.S. patents and numerous pending applications. These patents cover both the composition of matter for (Z)-endoxifen and innovative formulation approaches, ensuring a competitive edge in the market. By protecting its technology and research investments, the company lays a solid foundation for long-term value creation, even as it navigates the challenges inherent to clinical stage development.
Competitive Landscape and Industry Expertise
Operating within the highly competitive biopharmaceutical industry, Atossa Therapeutics distinguishes itself through its integrated approach to drug development and delivery innovation. Its expertise in designing treatments that address both the efficacy and tolerability aspects of cancer care positions it uniquely among its peers. The company’s focus on precise molecular targeting and the development of therapeutics that are supported by robust scientific data bolsters its role as a knowledgeable and expertly positioned player in the oncology landscape.
Business Model and Operational Strategy
- Clinical Innovation: Concentrates on advancing clinical programs with a focus on unmet needs in breast cancer and breast health conditions.
- Targeted Delivery: Emphasizes pioneering approaches in delivering therapies directly to disease sites, using technologies like intraductal microcatheter systems.
- Intellectual Property: Leverages a strong portfolio of patents to secure its technological advancements and maintain market differentiation.
- Collaborative Research: Engages in strategic partnerships and clinical collaborations to enhance its research capabilities and validate its clinical hypotheses.
Conclusion
Atossa Therapeutics Inc exemplifies a focused, research-driven approach to addressing significant challenges in oncology. By combining novel therapeutic agents with innovative delivery systems, the company provides a comprehensive model for advancing personalized breast cancer treatment. Its commitment to enhancing patient outcomes through scientific rigor and technological innovation underscores its importance in the dynamic field of biopharmaceutical research. The detailed clinical programs, strategic intellectual property protections, and collaborative research efforts are all testaments to its expertise and nuanced understanding of complex oncology treatment paradigms.
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.
Atossa Therapeutics (NASDAQ: ATOS) announced Q3 2024 financial results and corporate updates. Key highlights include positive topline results from KARISMA-Endoxifen Phase 2 study showing significant mammographic breast density reductions of 19.3% and 26.5% in 1mg and 2mg treatment arms. The I-SPY 2 trial met its primary endpoint with 95% of patients completing treatment, showing 69% reduction in Ki-67 and 30.4% reduction in tumor volume. The company ended Q3 with $74.8 million in cash and no debt. Operating expenses decreased to $6.4 million in Q3 2024 from $7.5 million in Q3 2023.
Atossa Therapeutics (Nasdaq: ATOS) has appointed Claudia Lopez, DVM, MSc, as Vice President of Clinical Product Development. Dr. Lopez brings over 20 years of clinical development and strategic expertise, particularly in immunology, oncology, and metabolic disease. Previously Vice President of Clinical Development at Landos Biopharma, she has held leadership positions at Arena Pharmaceuticals and Takeda Pharmaceuticals. In her new role, Dr. Lopez will focus on advancing Atossa's clinical pipeline for breast cancer treatments, leveraging her experience in global clinical strategies, trial design, and regulatory alignment.
Atossa Therapeutics (ATOS) announced positive topline data from the KARISMA-Endoxifen Phase 2 study testing (Z)-endoxifen in premenopausal women with mammographic breast density (MBD). The study, conducted at Karolinska Institute, showed significant MBD reduction with low doses. Key results include:
- Relative density decrease of -19.3% and -26.5% for 1mg and 2mg doses respectively vs placebo
- Mean endoxifen plasma concentration of 5.18 ng/mL (1mg) and 10.87 ng/mL (2mg)
- side effects with only mild vasomotor symptoms reported
- Study included 240 women across three arms (80 each) over six months
Atossa Therapeutics (ATOS) announced promising preliminary results from a phase 2 trial of (Z)-endoxifen in the I-SPY 2 Endocrine Optimization Pilot study. The trial, involving 20 women with ER+/HER2- breast cancer, met its primary endpoint with 95% of patients receiving >75% of planned treatment at 10mg daily dose. Key findings showed a 69% reduction in Ki-67 (cancer cell division marker) and a 30.4% decrease in functional tumor volume after 3 weeks. The treatment was well-tolerated with only mild side effects reported, including hot flushes, insomnia, and fatigue, with no dose reductions or discontinuations required.
Atossa Therapeutics (NASDAQ: ATOS) announced its participation in a fireside chat at BIO-Europe 2024 in Stockholm, Sweden. The event, scheduled for November 4-6, 2024, will feature Dr. Steven Quay, CEO of Atossa, and Dr. Per Hall from the Karolinska Institute discussing the potential of combining AI-based risk models with emerging therapies to prevent breast cancer in high-risk patients.
The discussion will focus on the Stockholm Mammography Risk Stratified Trial (SMART), a study aiming to enroll 70,000 women to test an individualized, imaging-based screening model. This model is designed to identify women at the highest risk of developing breast cancer within two years. If validated, it could serve as a foundation for future trials investigating (Z)-endoxifen in breast cancer prevention.
Atossa Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines for oncology, with a focus on breast cancer prevention and treatment using (Z)-endoxifen.
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