Latest news with #Atossa
Globe and Mail
6 days ago
- Business
- Globe and Mail
ER+/ HER2-VE Breast Cancer Pipeline Outlook Report 2025: Key 20+ Companies and Breakthrough Therapies Shaping the Future Landscape
DelveInsight's, 'ER positive, HER2 negative Breast Cancer Pipeline Insight 2025' report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in ER positive, HER2 negative Breast Cancer pipeline landscape. It covers the ER+/ HER2 -ve Breast Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the ER+/ HER2 -ve Breast Cancer therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Stay ahead with the latest insights! Download DelveInsight's comprehensive ER+/ HER2 -ve Breast Cancer Pipeline Report to explore emerging therapies, key Companies, and future treatment landscapes @ ER+/ HER2 -ve Breast Cancer Pipeline Outlook Report In August 2025, Yale University announced a phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial. Patients with ER+ breast cancer anatomic stage IIB or III at diagnosis who are at least five years from diagnosis and have completed intended course of adjuvant endocrine therapy and are currently off endocrine therapy will be screened with ctDNA testing. In July 2025, Atossa Therapeutics Inc. announced a study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or "SERM", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part. DelveInsight's ER+/ HER2 -ve Breast Cancer pipeline report depicts a robust space with 20+ active players working to develop 25+ pipeline therapies for ER+/ HER2 -ve Breast Cancer treatment. The leading ER+/ HER2 -ve Breast Cancer Companies such as AstraZeneca, Atossa Therapeutics, Inc., Accutar Biotechnology Inc, VelosBio Inc, Merus N.V., Pfizer, Olema Pharmaceuticals, Inc., Eli Lilly and Company, Novartis Pharmaceuticals, Hoffmann-La Roche, Ellipses Pharma, BeiGene and others. Promising ER+/ HER2 -ve Breast Cancer Therapies such as Entinostat, Aromatase Inhibitor (AI) Therapy, cetuximab, cisplatin, Palbociclib 125Mg Tab and others. Discover how the ER+/ HER2 -ve Breast Cancer treatment paradigm is evolving. Access DelveInsight's in-depth pipeline Analysis for a closer look at promising breakthroughs @ ER+/ HER2 -ve Breast Cancer Clinical Trials and Studies Camizestrant: AstraZeneca Camizestrant, is a next-generation oral selective estrogen receptor degrader (SERD), as a promising treatment for ER-positive, HER2-negative breast cancer. This drug, developed by AstraZeneca, and has shown significant potential in improving progression-free survival (PFS) compared to the standard treatment with fulvestrant, which has been the mainstay therapy for almost two decades. Camizestrant has demonstrated significant efficacy in clinical trials, particularly the SERENA-2 phase II trial. In this study, camizestrant was compared to fulvestrant, a well-established treatment. Patients receiving camizestrant showed improved progression-free survival (PFS) at doses of 75 mg and 150 mg, with median PFS of 7.2 and 9.2 months, respectively, compared to 3.7 months for those on fulvestrant. This trial also highlighted camizestrant's ability to reduce ESR1-mutant circulating tumor DNA, indicating a strong efficacy in combatting endocrine-resistant tumors. Safety profiles from these studies indicate that camizestrant is generally well-tolerated, with manageable side effects such as fatigue, anemia, and mild visual disturbances. The favorable balance between efficacy and safety has supported the advancement of camizestrant into further phase III trials, like SERENA-4 and SERENA-6, which are exploring its use in combination with CDK4/6 inhibitors for broader clinical application. Currently, the drug is in Phase III stage of its development for the treatment of HER2-negative breast cancer. (Z)-endoxifen: Atossa Therapeutics, Inc. (Z)-endoxifen is the most active metabolite of the FDA approved Selective Estrogen Receptor Modulator (SERM), tamoxifen. Studies have demonstrated that the therapeutic effects of tamoxifen are driven in a concentration-dependent manner by (Z)-endoxifen. In addition to its potent anti-estrogen effects, (Z)-endoxifen at higher concentrations has been shown to target PKCβ1, a known oncogenic protein. (Z)-endoxifen also appears to deliver similar or even greater bone agonistic effects while resulting in little or no endometrial proliferative effects compared with tamoxifen. Atossa is developing a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach as acidic conditions in the stomach convert a greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa's (Z)-endoxifen has been shown to be well tolerated in Phase I studies and in a small Phase II study of women with breast cancer. Currently, the drug is in Phase II stage of its development for the treatment of ER-positive, HER2-negative breast cancer. AC699 is a potent and selective orally bioavailable, chimeric degrader of estrogen receptor (ER) α, and offers a potential new breast cancer treatment option based on a differentiated mechanism of action as compared to fulvestrant and novel SERDs with deeper ERα degradation as demonstrated in preclinical studies. AC699 is currently being evaluated in an ongoing Phase I clinical study as a single agent for the treatment of ER-positive / HER2-negative locally advanced or metastatic breast cancer. The primary objectives are to evaluate the safety and tolerability of AC699. Secondary and exploratory objectives include pharmacokinetics, preliminary efficacy and pharmacodynamic evaluation. The study uses a 3+3 dose-escalation design, with once-daily oral dosing of AC699 at 100, 200, 300, 400, and 600 mg. The ER+/ HER2 -ve Breast Cancer pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of ER+/ HER2 -ve Breast Cancer with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for ER+/ HER2 -ve Breast Cancer Treatment. ER+/ HER2 -ve Breast Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. ER+/ HER2 -ve Breast Cancer Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the ER+/ HER2 -ve Breast Cancer market. Get a detailed analysis of the latest innovations in the ER+/ HER2 -ve Breast Cancer pipeline. Explore DelveInsight's expert-driven report today! @ ER+/ HER2 -ve Breast Cancer Unmet Needs ER+/ HER2 -ve Breast Cancer Companies AstraZeneca, Atossa Therapeutics, Inc., Accutar Biotechnology Inc, VelosBio Inc, Merus N.V., Pfizer, Olema Pharmaceuticals, Inc., Eli Lilly and Company, Novartis Pharmaceuticals, Hoffmann-La Roche, Ellipses Pharma, BeiGene and others. ER+/ HER2-VE Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical ER+/ HER2 -ve Breast Cancer Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Download DelveInsight's latest report to gain strategic insights into upcoming ER+/ HER2 -ve Breast Cancer Therapies and key developments @ ER+/ HER2 -ve Breast Cancer Market Drivers and Barriers, and Future Perspectives Scope of the ER+/ HER2 -ve Breast Cancer Pipeline Report Coverage- Global ER+/ HER2 -ve Breast Cancer Companies- AstraZeneca, Atossa Therapeutics, Inc., Accutar Biotechnology Inc, VelosBio Inc, Merus N.V., Pfizer, Olema Pharmaceuticals, Inc., Eli Lilly and Company, Novartis Pharmaceuticals, Hoffmann-La Roche, Ellipses Pharma, BeiGene and others. ER+/ HER2 -ve Breast Cancer Therapies- Entinostat, Aromatase Inhibitor (AI) Therapy, cetuximab, cisplatin, Palbociclib 125Mg Tab and others. ER+/ HER2 -ve Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination ER+/ HER2 -ve Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Which companies are leading the race in ER+/ HER2 -ve Breast Cancer drug development? Find out in DelveInsight's exclusive pipeline Report—access it now! @ ER+/ HER2 -ve Breast Cancer Emerging Drugs and Major Companies Table of Content Introduction Executive Summary ER+/ HER2-VE Breast Cancer: Overview Pipeline Therapeutics Therapeutic Assessment ER positive, HER2 negative Breast Cancer– DelveInsight's Analytical Perspective Late Stage Products (Phase III) Camizestrant: AstraZeneca Drug profiles in the detailed report….. Mid Stage Products (Phase II) (Z)-endoxifen: Atossa Therapeutics, Inc. Drug profiles in the detailed report….. Early Stage Products (Phase I) AC699: Accutar Biotechnology Inc Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug Name: Company Name Drug profiles in the detailed report….. Inactive Products ER+/ HER2-VE Breast Cancer Key Companies ER+/ HER2-VE Breast Cancer Key Products ER+/ HER2-VE Breast Cancer- Unmet Needs ER+/ HER2-VE Breast Cancer- Market Drivers and Barriers ER+/ HER2-VE Breast Cancer- Future Perspectives and Conclusion ER+/ HER2-VE Breast Cancer Analyst Views ER+/ HER2-VE Breast Cancer Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
Yahoo
02-06-2025
- Business
- Yahoo
Atossa Therapeutics to Present at the Jefferies Global Healthcare Conference
SEATTLE, June 2, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced that Dr. Steven Quay, M.D., Ph.D., President and Chief Executive Officer, will present at the Jefferies Global Healthcare Conference on Thursday, June 5, 2025 at 7:35 a.m. Eastern Time. A live webcast of the presentation can be accessed on the Investors section of the Atossa website under "Events and Presentations" at The webcast will be archived for 30 days. About Atossa TherapeuticsAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company dedicated to transforming breast cancer treatment through innovative science and patient-focused solutions. The company's lead product candidate, (Z)-endoxifen, is a highly potent SERM designed for use across the breast cancer spectrum, including prevention, neoadjuvant, adjuvant, and metastatic settings. Atossa is committed to advancing its robust clinical research programs to improve patient outcomes while creating sustainable value for shareholders. For more information, visit View original content to download multimedia: SOURCE Atossa Therapeutics Inc Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
20-05-2025
- Business
- Associated Press
Join Atossa Therapeutics' Exclusive Live Investor Webinar and Q&A Session on May 22
SEATTLE, WASHINGTON / ACCESS Newswire / May 20, 2025 / Atossa Therapeutics, Inc. (Nasdaq:ATOS) ('Atossa' or the 'Company'), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, is pleased to invite investors to a webinar on May 22, 2025, at 4:15 p.m. ET. The exclusive event, hosted by RedChip Companies, will feature Dr. Steven Quay, CEO of Atossa Therapeutics. Attendees will gain insight into Atossa's strategic approach to redefining breast cancer treatment through its lead clinical candidate, (Z)-endoxifen - a next-generation SERM with best-in-class potential. With a focus on metastatic breast cancer, where current therapies often fall short, Atossa is advancing multiple Phase 2 studies that demonstrate strong clinical activity, improved tolerability, and a favorable safety profile. The presentation will highlight recent progress across key development programs, upcoming milestones, and how the Company's differentiated science and capital-efficient model are designed to deliver both clinical impact and long-term shareholder value. A live question and answer session will follow the presentation. To register for the free webinar, please visit: Questions can be pre-submitted to [email protected] or online during the live event. About Atossa Therapeutics Atossa Therapeutics, Inc. (Nasdaq:ATOS) is a clinical-stage biopharmaceutical company dedicated to transforming breast cancer treatment through innovative science and patient-focused solutions. The company's lead product candidate, (Z)-endoxifen, is a highly potent SERM designed for use across the breast cancer spectrum, including prevention, neoadjuvant, adjuvant, and metastatic settings. Atossa is committed to advancing its robust clinical research programs to improve patient outcomes while creating sustainable value for shareholders. For more information, visit FORWARD LOOKING STATEMENTS This press release contains certain information that may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We may identify these forward-looking statements by the use of words such as 'expect,' 'potential,' 'continue,' 'may,' 'will,' 'should,' 'could,' 'would,' 'seek,' 'intend,' 'plan,' 'estimate,' 'anticipate,' 'believe,' 'design,' 'predict,' 'future,' or other comparable words. All statements made in this press release that are not statements of historical fact, including statements regarding data related to the (Z)-endoxifen program, the safety, tolerability and efficacy of (Z)-endoxifen, the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval, benefits of the Company's strategy of pursuing a metastatic indication for (Z)-endoxifen, the expected design and enrollment of trials and timing of data and related publications, and the potential market and growth opportunities for the Company, are forward-looking statements. Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes, to differ materially from those projected or anticipated, including risks and uncertainties associated with: our ability to obtain patent coverage for our product candidates; macroeconomic conditions and increasing geopolitical instability; the expected timing of releasing data; any variation between interim or preliminary and final clinical results or analysis; actions and inactions by the FDA and foreign regulatory bodies; the outcome or timing of regulatory approvals needed by Atossa, including those needed to continue our planned (Z)-endoxifen trials; our ability to satisfy regulatory requirements; our ability to regain compliance or maintain compliance with the continued listing requirements of the Nasdaq Stock Market; our ability to successfully develop and commercialize new therapeutics; the success, costs and timing of our development activities, including our ability to successfully initiate or complete our clinical trials, including our (Z)-endoxifen trials; our anticipated rate of patient enrollment; our ability to contract with third-parties and their ability to perform adequately; our estimates on the size and characteristics of our potential markets; our ability to successfully defend litigation and other similar complaints and to establish and maintain intellectual property rights covering our products; whether we can successfully complete our clinical trial of oral (Z)-endoxifen in women with mammographic breast density and our trials of (Z)-endoxifen in women with breast cancer, and whether the studies will meet their objectives; our expectations as to future financial performance, expense levels and capital sources, including our ability to raise capital; our ability to attract and retain key personnel; our anticipated working capital needs and expectations around the sufficiency of our cash reserves; and other risks and uncertainties detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its Annual Reports on Form 10-K and Quarterly Reports on 10-Q. Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Contact: Michael Parks VP, Investor and Public Relations 484-356-7105 [email protected] Contact: Dave Gentry RedChip Companies, Inc. 1-407-644-4256 [email protected] SOURCE: Atossa Therapeutics, Inc. press release
Yahoo
14-05-2025
- Business
- Yahoo
Atossa Therapeutics Announces Full Results from I‑SPY 2 Endocrine‑Optimization Sub‑Study Evaluating Low‑Dose (Z)‑Endoxifen
Feasibility endpoint achieved; rapid Ki‑67 suppression and substantial MRI‑confirmed tumor shrinkage observed with favorable safety profile SEATTLE, May 14, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today reported full results from the Phase 2 Endocrine Optimization Pilot (EOP) sub‑study within the I‑SPY 2 TRIAL evaluating low‑dose oral (Z)‑endoxifen (10 mg daily) as a neoadjuvant treatment in 20 women with stage II/III estrogen‑receptor–positive (ER+), HER2‑negative breast cancer. Key Findings: Primary feasibility goal surpassed – 95 percent of participants (19/20) completed at least 75 percent of planned dosing, far exceeding the predefined 75 percent threshold. Early anti‑proliferative activity – Median Ki‑67 fell from 10.5 percent at baseline to 5 percent by Week 3 (prior to ovarian suppression); 65 percent of patients achieved Ki‑67 ≤ 10 percent at that time point, and suppression was maintained at surgery. Robust imaging response – Median functional tumor volume (FTV) measurement (performed at baseline, week 3, week 12, and at surgery) decreased 77.7 percent (range 9.0 cc → 1.2 cc) from baseline to surgery, and the longest tumor diameter from baseline to preoperative MRI was reduced by 36.8 percent. Well‑tolerated safety profile – Adverse events were predominantly Grade 1; vasomotor symptoms (hot flushes) and fatigue were most common. Only three Grade 3 events (two skin infections, one post‑procedural infection) occurred in a single patient and were deemed unrelated to study drug; no Grade 4 or Grade 5 events were reported. Pathologic Findings:No participants achieved a pathologic complete response (pCR), and residual cancer burden (RCB) classes skewed toward RCB‑II/III, indicating moderate to extensive residual disease. This result was anticipated based on earlier window‑of‑opportunity (neoadjuvant) studies that showed significant pathologic clearance typically requires higher systemic exposures to (Z)-endoxifen (> 500 ng/mL) to enable inhibition of PKCβ1 in addition to ERα. The 10 mg dose in this pilot was intentionally selected to establish tolerability and early biologic activity in the endocrine‑naïve setting; therefore, limited pCR rates at this dose are consistent with prior dose–response observations. "These results show that even at a low capsule strength (Z)‑endoxifen is bioactive, producing rapid Ki‑67 suppression and meaningful tumor shrinkage, while remaining highly tolerable. The study strengthens our scientific hypothesis that dual targeting of ERα and PKCβ1 is key to inducing a pathological response," said Steven Quay, M.D., Ph.D., President and Chief Executive Officer of Atossa. "Importantly, it paves the way for our ongoing I‑SPY 2 cohorts evaluating higher, potentially PKCβ1‑engaging doses of (Z)‑endoxifen alone and in combination with the CDK4/6 inhibitor abemaciclib, where we aim to translate early biomarker gains into deeper pathologic responses." Atossa is actively enrolling participants into an additional I‑SPY 2 cohort testing (Z)‑endoxifen at a 40 mg daily dose and in combination with abemaciclib, with and without ovarian function suppression. Top‑line data from these arms are expected beginning in 2026. About (Z)-Endoxifen(Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator (SERM) with demonstrated ability to inhibit—and potentially degrade—estrogen receptors. It has shown activity even in tumors that have developed resistance to other endocrine therapies. Beyond its anti-estrogenic properties, (Z)-endoxifen also targets protein kinase C beta 1 (PKCβ1), an oncogenic signaling protein, at clinically achievable blood levels. Importantly, (Z)-endoxifen seems to deliver comparable or superior bone-protective effects relative to tamoxifen, while exhibiting minimal or no endometrial proliferative activity—addressing key limitations of current standard-of-care therapies. Atossa is developing a proprietary oral formulation of (Z)-endoxifen that is enteric-coated to bypass stomach acid, which would otherwise convert the active (Z)-isomer to its inactive (E)-form. This innovation ensures optimal bioavailability and therapeutic integrity. Clinical studies have shown Atossa's (Z)-endoxifen to be well tolerated in both healthy women and those with breast cancer. Atossa is prioritizing the development of (Z)-endoxifen for the treatment of metastatic breast cancer, where novel therapeutic options are urgently needed. The compound is currently being evaluated in three Phase 2 trials: one in women with ductal carcinoma in situ (DCIS) and two in women with ER+/HER2- breast cancer, including the EVANGELINE trial and the combination I-SPY study. Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including three recently issued U.S. patents and numerous pending applications worldwide. About Atossa TherapeuticsAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company dedicated to transforming breast cancer treatment through innovative science and patient-focused solutions. The company's lead product candidate, (Z)-endoxifen, is a highly potent SERM designed for use across the breast cancer spectrum, including prevention, neoadjuvant, adjuvant, and metastatic settings. Atossa is committed to advancing its robust clinical research programs to improve patient outcomes while creating sustainable value for shareholders. For more information, visit FORWARD LOOKING STATEMENTSThis press release contains certain information that may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We may identify these forward-looking statements by the use of words such as "expect," "potential," "continue," "may," "will," "should," "could," "would," "seek," "intend," "plan," "estimate," "anticipate," "believe," "design," "predict," "future," or other comparable words. All statements made in this press release that are not statements of historical fact, including statements regarding data related to the (Z)-endoxifen program, the safety, tolerability and efficacy of (Z)-endoxifen, the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval, benefits of the Company's strategy of pursuing a metastatic indication for (Z)-endoxifen, the expected design and enrollment of trials and timing of data and related publications, and the potential market and growth opportunities for the Company, are forward-looking statements. Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes, to differ materially from those projected or anticipated, including risks and uncertainties associated with: our ability to obtain patent coverage for our product candidates; macroeconomic conditions and increasing geopolitical instability; the expected timing of releasing data; any variation between interim or preliminary and final clinical results or analysis; actions and inactions by the FDA and foreign regulatory bodies; the outcome or timing of regulatory approvals needed by Atossa, including those needed to continue our planned (Z)-endoxifen trials; our ability to satisfy regulatory requirements; our ability to regain compliance or maintain compliance with the continued listing requirements of the Nasdaq Stock Market; our ability to successfully develop and commercialize new therapeutics; the success, costs and timing of our development activities, including our ability to successfully initiate or complete our clinical trials, including our (Z)-endoxifen trials; our anticipated rate of patient enrollment; our ability to contract with third-parties and their ability to perform adequately; our estimates on the size and characteristics of our potential markets; our ability to successfully defend litigation and other similar complaints and to establish and maintain intellectual property rights covering our products; whether we can successfully complete our clinical trial of oral (Z)-endoxifen in women with mammographic breast density and our trials of (Z)-endoxifen in women with breast cancer, and whether the studies will meet their objectives; our expectations as to future financial performance, expense levels and capital sources, including our ability to raise capital; our ability to attract and retain key personnel; our anticipated working capital needs and expectations around the sufficiency of our cash reserves; and other risks and uncertainties detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its Annual Reports on Form 10-K and Quarterly Reports on 10-Q. Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. View original content to download multimedia: SOURCE Atossa Therapeutics Inc Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
29-04-2025
- Business
- Associated Press
Atossa Therapeutics Proposes Potentially Groundbreaking Study Aimed at Reducing Interval Breast Cancer in High-Risk Women at AACR 2025
SEATTLE, April 29, 2025 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ('Atossa' or the 'Company'), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today outlined a framework for a pioneering Phase 3 clinical study titled SMART 2.0. The proposed trial would investigate the potential of oral (Z)-endoxifen, a potent Selective Estrogen Receptor Modulator (SERM) for estrogen receptor inhibition, to significantly reduce interval breast cancer in women identified as high-risk through advanced mammographic screening techniques. The proposed SMART 2.0 study was presented at the American Association for Cancer Research (AACR) Annual Meeting and represents a future research program and potential partnership opportunity to advance this critical initiative for women at high risk of breast cancer. Interval breast cancers, diagnosed between regular mammography screenings, are typically more aggressive and challenging to treat than screen-detected cancers. Mammographic density has been recognized as a critical, modifiable risk factor for breast cancer and can complicate early detection. Previous research indicates (Z)-endoxifen, like tamoxifen, effectively reduces breast density and potentially enhances mammogram sensitivity. However, the adverse effects associated with tamoxifen limit its widespread use. Atossa's innovative approach utilizes low-dose (1mg) Z-endoxifen, which reduced mammographic density by nearly 20 percent at six months and systemic side effects that were not statistically different than placebo in the Phase 2 KARISMA trial - an important step toward lowering the risk of interval breast cancer. The proposed SMART 2.0 trial would randomize participants identified by leveraging an AI Risk model into treatment and placebo groups to evaluate the effectiveness of (Z)-endoxifen over two years. The primary endpoint would measure the relative reduction in interval breast cancer incidence and tolerability compared to placebo over a two-year period of time. 'The SMART 2.0 study proposal represents a significant step forward for the advancement of breast cancer prevention,' said Steven C. Quay, CEO of Atossa Therapeutics. 'By targeting mammographic density with Z-endoxifen, we hope to establish a safer, more effective preventive therapy for women at high risk.' The company aspires to conduct a trial such as this in the future in an effort to provide the pivotal data required for regulatory approval of Z-endoxifen as a preventative treatment option. About (Z)-Endoxifen (Z)-endoxifen is one of the most potent Selective Estrogen Receptor Modulator (SERM) for estrogen receptor inhibition and may cause estrogen receptor degradation. It has also been shown to have efficacy in the setting of patients with tumor resistance to other hormonal treatments. In addition to its potent anti-estrogen effects, (Z)-endoxifen has been shown to target PKCβ1, a known oncogenic protein, at clinically attainable blood concentrations. Finally, (Z)-endoxifen appears to deliver similar or even greater bone agonistic effects while resulting in little or no endometrial proliferative effects compared with standard treatments, like tamoxifen. Atossa is developing a proprietary oral formulation of (Z)-endoxifen that is encapsulated to bypass the stomach, as acidic conditions in the stomach convert a significant proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa's (Z)-endoxifen has been shown to be well tolerated in clinical studies of women with and without breast cancer. (Z)-endoxifen is currently being studied both for the treatment and prevention of breast cancer, including a program in metastatic breast cancer that was announced earlier this year. About Atossa Therapeutics Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company dedicated to transforming breast cancer treatment through innovative science and patient-focused solutions. The company's lead product candidate, (Z)-endoxifen, is a highly potent SERM designed for use across the breast cancer spectrum, including prevention, neoadjuvant, adjuvant, and metastatic settings. Atossa is committed to advancing its robust clinical research programs to improve patient outcomes while creating sustainable value for shareholders. For more information, visit FORWARD LOOKING STATEMENTS This press release contains certain information that may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We may identify these forward-looking statements by the use of words such as 'expect,' 'potential,' 'continue,' 'may,' 'will,' 'should,' 'could,' 'would,' 'seek,' 'intend,' 'plan,' 'estimate,' 'anticipate,' 'believe,' 'design,' 'predict,' 'future,' or other comparable words. All statements made in this press release that are not statements of historical fact, including statements regarding data related to the (Z)-endoxifen program, the safety, tolerability and efficacy of (Z)-endoxifen, the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval, benefits of the Company's strategy of pursuing a metastatic indication for (Z)-endoxifen, the expected design and enrollment of trials and timing of data and related publications, and the potential market and growth opportunities for the Company, are forward-looking statements. Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes, to differ materially from those projected or anticipated, including risks and uncertainties associated with: our ability to obtain patent coverage for our product candidates; macroeconomic conditions and increasing geopolitical instability; the expected timing of releasing data; any variation between interim or preliminary and final clinical results or analysis; actions and inactions by the FDA and foreign regulatory bodies; the outcome or timing of regulatory approvals needed by Atossa, including those needed to continue our planned (Z)-endoxifen trials; our ability to satisfy regulatory requirements; our ability to regain compliance or maintain compliance with the continued listing requirements of the Nasdaq Stock Market; our ability to successfully develop and commercialize new therapeutics; the success, costs and timing of our development activities, including our ability to successfully initiate or complete our clinical trials, including our (Z)-endoxifen trials; our anticipated rate of patient enrollment; our ability to contract with third-parties and their ability to perform adequately; our estimates on the size and characteristics of our potential markets; our ability to successfully defend litigation and other similar complaints and to establish and maintain intellectual property rights covering our products; whether we can successfully complete our clinical trial of oral (Z)-endoxifen in women with mammographic breast density and our trials of (Z)-endoxifen in women with breast cancer, and whether the studies will meet their objectives; our expectations as to future financial performance, expense levels and capital sources, including our ability to raise capital; our ability to attract and retain key personnel; our anticipated working capital needs and expectations around the sufficiency of our cash reserves; and other risks and uncertainties detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its Annual Reports on Form 10-K and Quarterly Reports on 10-Q. Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Contact: Michael Parks VP, Investor and Public Relations 484-356-7105 [email protected]
