Atossa Therapeutics

Atossa's (Z)-Endoxifen Shows 77.7% Tumor Reduction in Phase 2 Breast Cancer Trial

10 days ago

• 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 Shifts Focus to Metastatic Breast Cancer with (Z)-Endoxifen, Strengthens Patent Portfolio

11 days ago

• 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 Unveils SMART 2.0 Study to Reduce Interval Breast Cancer in High-Risk Women

25 days ago

• 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.

Dostarlimab Shows Promise in Eliminating Need for Surgery Across Multiple dMMR Cancer Types

a month ago

• Phase 2 trial results reveal dostarlimab (Jemperli) induced complete clinical responses in 100% of rectal cancer patients and 65% of non-rectal cancer patients with mismatch repair-deficient tumors, allowing 82 of 84 responders to avoid surgery. • The groundbreaking study demonstrated 92% recurrence-free survival at two years, with some patients maintaining complete responses for up to five years, potentially transforming treatment approaches for dMMR cancers. • Researchers highlight the significant quality-of-life benefits of avoiding surgical resection, particularly important for younger patients facing colorectal cancer diagnoses, as surgery can be debilitating and financially burdensome.

Nona Biosciences Expands Reach with Strategic Partnerships in Animal Health and Breast Cancer Therapeutics

4 months ago

• 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.

CAR-T Cell Therapy Industry Surges to $141.2 Billion in Funding as Clinical Success Drives Investment

5 months ago

• The CAR-T cell therapy industry has raised over $141.2 billion through various financing mechanisms, with potential total value reaching $281.7 billion when including undisclosed deals. • Since 2014, 89 CAR-T companies have secured $7.7 billion in venture capital funding, while 42 companies have raised $6.4 billion through IPOs, demonstrating sustained investor confidence. • Despite a slowdown in M&A activity in 2024, the sector continues to expand with 170+ companies developing 1,944 therapies, including 244 trials targeting solid tumors beyond the current blood cancer focus.

OS Therapies Advances OST-HER2 Towards FDA Submission with Manufacturing Agreements

5 months ago

• OS Therapies has initiated commercial manufacturing for OST-HER2, an immunotherapy targeting HER2, in preparation for a BLA submission to the FDA. • The company completed a Phase 2b trial of OST-HER2 for recurrent lung metastatic osteosarcoma, with positive results reported in early 2025. • OS Therapies anticipates a Type B or Type C meeting with the FDA before submitting the BLA for accelerated or conditional approval. • A patent notice of allowance from the USPTO provides market exclusivity for OST-HER2 commercial drug product into 2040.

Atossa Therapeutics' (Z)-Endoxifen Shows Promise in Phase 2 Breast Cancer Trial

5 months ago

• Atossa Therapeutics presented Phase 2 EVANGELINE trial data at SABCS 2024, evaluating (Z)-endoxifen for ER+/HER2-negative breast cancer in premenopausal women. • The trial achieved its primary endpoint, with 50% of patients on 80mg (Z)-endoxifen plus goserelin reaching target plasma concentrations. • Treatment demonstrated substantial tumor suppression, with Ki-67 response rates exceeding 85% across all dosing levels, indicating significant anti-tumor activity. • Based on these results, a randomized trial comparing 40mg (Z)-endoxifen plus OFS to exemestane plus OFS is planned to commence recruitment in 2025.

VistaGen's Fasedienol Shows Promise in Phase 3 Trials for Social Anxiety Disorder

6 months ago

• VistaGen's Phase 3 trials for fasedienol in acute social anxiety disorder are progressing, with PALISADE-4 active and results expected from PALISADE-3 and PALISADE-4 in 2025. • The Phase 2 PALISADE-2 trial demonstrated significant positive results, supporting the ongoing Phase 3 studies for fasedienol in treating social anxiety disorder. • VistaGen is also advancing itruvone for major depressive disorder, with a Phase 2b study planned after encouraging Phase 2a results, expanding its pipeline. • With a cash reserve of $97.6 million, VistaGen is financially stable through fiscal year 2026, supporting its clinical development programs.

Atossa's Endoxifen Shows Promise in Reducing Mammographic Breast Density in Phase II Trial

7 months ago

• Novel selective estrogen receptor modulator (Z)-endoxifen demonstrates significant reduction in mammographic breast density in premenopausal women during Phase II KARISMA trial. • The study represents a potential breakthrough in breast cancer risk management, as high mammographic density is a known risk factor for breast cancer development. • Atossa Therapeutics' advancement of endoxifen marks an important development in preventive breast cancer therapeutics, offering a potential new intervention option.

(Z)-Endoxifen Demonstrates Significant Reduction in Mammographic Breast Density in Phase 2 Trial

7 months ago

• Atossa Therapeutics' Phase 2 KARISMA-Endoxifen trial shows (Z)-endoxifen significantly reduces mammographic breast density (MBD) in premenopausal women. • The study found a relative significant density change of -19.3% and -26.5% in the 1 mg and 2 mg arms, respectively, compared to placebo. • (Z)-endoxifen was generally well-tolerated, with only a slight increase in vasomotor symptoms reported during the six-month trial period. • These results suggest (Z)-endoxifen could potentially offer a novel approach to breast cancer prevention, especially for women with dense breasts.

Breakthroughs in Biotech: Promising Developments in Diabetes, Cancer, and Lymphoma Treatments

2 years ago

Recent advancements in the biotech sector highlight significant progress in treatments for diabetes, breast cancer, multiple myeloma, and T cell lymphoma, with several companies receiving FDA approvals or making notable strides in clinical trials.