Atossa Therapeutics, Inc. operates as a clinical-stage pharmaceutical company, which engages in the development of novel therapeutics and delivery methods for the treatment of breast cancer and other breast conditions. The company was founded by Steven C. Quay and Shu Chih Chen in December 2008 and is headquartered in Seattle, WA.
相关临床试验
10
2 进行中
药物批准
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成立时间
2009
进行中（未招募）
2
20.0%
已完成
6
60.0%
终止
1
10.0%
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1
10.0%
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- A new study from Karolinska Institutet demonstrates that low-dose endoxifen, tamoxifen's active metabolite, reduces breast density as effectively as standard tamoxifen treatment. - The trial found that 1 mg of endoxifen reduced breast density by 19% and 2 mg by 26%, comparable to tamoxifen's 18.5% reduction. - Participants receiving 1 mg endoxifen experienced a safety profile similar to placebo, suggesting better tolerability than current tamoxifen therapy. - The proof-of-concept study involved 240 healthy premenopausal women and represents a potential breakthrough for breast cancer prevention strategies.
- The FDA has granted Rare Pediatric Disease designation to Atossa Therapeutics' (Z)-Endoxifen for treating Duchenne Muscular Dystrophy, expanding the drug's development beyond oncology. - This regulatory milestone may qualify Atossa for a Priority Review Voucher upon approval, which has recently sold for $100-160 million. - (Z)-Endoxifen offers a differentiated mechanism as a SERM/D that doesn't target specific exon defects, potentially providing broader treatment access for DMD patients. - The designation provides enhanced FDA interaction and regulatory framework as Atossa advances the program toward clinical trials for this devastating childhood disease.
- The Duchenne Muscular Dystrophy market reached approximately $2.15 billion in 2023 and is expected to grow significantly due to increased drug uptake and anticipated gene therapy launches. - Over 75 companies are actively developing pipeline therapies for DMD, with recent FDA designations including Atossa Therapeutics' (Z)-Endoxifen receiving Rare Pediatric Disease designation. - Capricor Therapeutics announced positive Phase 3 HOPE-3 trial results for Deramiocel, while the FDA accepted their BLA for review with Priority Review designation. - Current approved treatments include EMFLAZA, VYONDYS 53, EXONDYS 51, AMONDYS 45, VILTEPSO, and gene therapy ELEVIDYS in the US, with AGAMREE launched in Germany in 2024.
- Insilico Medicine and Atossa Therapeutics published a comprehensive AI-enabled study in Nature Scientific Reports identifying (Z)-endoxifen as a potential treatment for glioblastoma multiforme, one of the deadliest brain tumors. - The research utilized Insilico's PandaOmics platform to evaluate over 900 cancer indications, revealing that endoxifen could counteract key pathways driving tumor growth and treatment resistance in glioblastoma. - Laboratory validation demonstrated that (Z)-endoxifen significantly suppressed GBM cell proliferation and induced apoptosis, showing greater cytotoxic activity than high-dose temozolomide in vitro. - The study represents a breakthrough in drug repurposing for glioblastoma, which has a devastating five-year survival rate of roughly 4%.
- The Evangeline Phase 2 clinical trial is evaluating (Z)-endoxifen as a chemotherapy-free treatment for premenopausal women with early-stage estrogen receptor-positive breast cancer. - Mayo Clinic researchers report success rates of 80% to 90% with endoxifen, which targets estrogen receptors without causing the severe menopausal side effects associated with current treatments. - The trial addresses a growing medical need as breast cancer rates are rising among women under 50, with physicians reporting increased diagnoses in patients in their twenties and thirties. - The study aims to provide superior efficacy compared to tamoxifen while avoiding the quality-of-life impacts of aromatase inhibitors that induce early menopause in younger patients.
- Atossa Therapeutics has amended its Phase II EVANGELINE study of (Z)-endoxifen for premenopausal women with ER+/HER2- breast cancer, reducing participant numbers from 214 to 40-65 to support NDA activities. - The I-SPY 2 trial demonstrated promising efficacy with 95% of subjects completing planned dosing and median Ki-67 levels dropping from 10.5% to 5% by week 3. - The company's proprietary enteric oral formulation of (Z)-endoxifen has shown favorable safety profiles across over 700 subjects with no maximum tolerated dose identified up to 360 mg/day. - Atossa is targeting an IND submission in Q4 2025 for metastatic breast cancer treatment while advancing multiple Phase 2 trials across different breast cancer indications.
- Atossa Therapeutics' low-dose (Z)-endoxifen demonstrated significant tumor shrinkage with a 77.7% reduction in functional tumor volume in women with ER+/HER2- breast cancer during the I-SPY 2 trial. - The drug exhibited rapid anti-proliferative activity with median Ki-67 levels dropping from 10.5% to 5% by week 3, while maintaining a favorable safety profile with predominantly Grade 1 adverse events. - Despite promising tumor shrinkage, no pathologic complete responses were observed at the 10mg dose, supporting the hypothesis that higher doses engaging PKC𝛽1 will be needed for optimal efficacy in future trials.
- Atossa Therapeutics has strategically repositioned (Z)-endoxifen to target metastatic breast cancer, addressing a significant unmet medical need where current treatments offer limited durability and substantial side effects. - The company has significantly expanded its intellectual property protection with three new U.S. patents, bringing its portfolio to over 200 patent claims related to (Z)-endoxifen formulations and applications. - (Z)-endoxifen, a potent selective estrogen receptor modulator (SERM), has demonstrated promising tolerability across multiple clinical trials and is currently being evaluated in three Phase 2 studies.
- Atossa Therapeutics has proposed a pioneering Phase 3 clinical study called SMART 2.0 to investigate if oral (Z)-endoxifen can reduce interval breast cancer in high-risk women identified through advanced mammographic screening. - The company's low-dose (1mg) (Z)-endoxifen reduced mammographic breast density by nearly 20 percent at six months in the Phase 2 KARISMA trial, with systemic side effects not statistically different from placebo. - Unlike tamoxifen, which has limiting adverse effects despite its effectiveness, (Z)-endoxifen appears to offer similar or greater bone benefits with minimal endometrial proliferative effects, potentially providing a safer preventive option.
- Nona Biosciences has entered a strategic collaboration with Invetx to develop next-generation animal health biotherapeutics using their proprietary HCAb Harbour Mice® platform, marking their first expansion into the animal health sector. - The company has also partnered with Atossa Therapeutics to discover novel antibody therapies for breast cancer, leveraging their H2L2 Harbour Mice® platform to identify next-generation therapeutic candidates. - Nona's Harbour Mice® technology generates fully human monoclonal antibodies in both conventional and heavy chain-only formats, offering significant advantages for antibody development across multiple therapeutic areas.
