NASDAQ:ATOS

Thinking about buying stock in Cardiff Oncology, BIOLASE, Akebia Therapeutics, Astera Labs, or Atossa Therapeutics?

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Tuesday, March 26, 2024

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Key Points: 
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Quantum Leap Healthcare Collaborative Initiates Landmark Phase 2 RECAST DCIS Platform Trial to Evaluate Alternative DCIS Treatments with Atossa Therapeutics, Havah Therapeutics, and the Menarini Group

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Monday, October 30, 2023

SAN FRANCISCO, Oct. 30, 2023 /PRNewswire/ -- Quantum Leap Healthcare Collaborative (QLHC) announces the enrollment launch for the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS), a Phase 2 platform study aimed at preventing the progression of DCIS to breast cancer. The study is evaluating three investigational endocrine therapy arms: (Z)-endoxifen, a selective estrogen receptor modulator (SERM) in development by Atossa Therapeutics (Nasdaq: ATOS); HAVAH T+Ai™, a proprietary combination of testosterone (T) and anastrozole (Ai) that targets the androgen and estrogen receptor pathways in development by Havah Therapeutics; and ORSERDU® (elacestrant), the only FDA approved oral selective estrogen receptor degrader (oSERD) in development by Stemline Therapeutics Inc. (Stemline), a wholly-owned subsidiary of the Menarini Group. 

Key Points: 
  • Surgery is the current standard treatment for DCIS even though many patients never progress to breast cancer, which means that patients are often over-treated with invasive procedures.
  • A key element in reducing overtreatment of DCIS is identifying biomarkers that reflect the risk of progression so that those with low-risk lesions are spared surgery.
  • RECAST DCIS features the assessment of imaging and molecular-based biomarkers in addition to evaluating new investigational agents in this setting.
  • The three collaborators for this trial, Atossa Therapeutics, Havah Therapeutics, and Stemline, all aim to find alternative solutions for DCIS patients and are providing different agents for assessment.

Fast-food consumption by adolescent girls may sow the seeds of breast cancer decades later

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Wednesday, October 11, 2023

SEATTLE, Oct. 11, 2023 /PRNewswire/ -- Physician-Scientist Dr. Steven Quay, MD, PhD is calling for nutritional guidelines for adolescent girls to reduce processed and fast-food consumption during puberty to prevent future breast cancer. His recommendation is based on recent research showing a link between consumption of a particular set of chemicals produced by the high temperatures used to fry or grill foods that have a high level of sugars and the induction of pre-cancerous changes during pubertal breast development. While the study was in mice, similar changes can be seen in adolescent breast development. A video explaining the paper and the basis of Dr. Quay's recommendation can be found here: Breast cancer prevention video.

Key Points: 
  • While the study was in mice, similar changes can be seen in adolescent breast development.
  • A video explaining the paper and the basis of Dr. Quay's recommendation can be found here: Breast cancer prevention video .
  • "Decades ago, I formulated a hypothesis that the seeds of future breast cancer are sown during puberty, when the breast is undergoing development.
  • The understanding of this link between breast development and future breast cancer should be used to inform nutritional guidelines for adolescent girls."

Societal CDMO Enters Agreement With Atossa Therapeutics to Provide Clinical Trial Services (CTS) for Innovative Selective Estrogen Receptor Modulator

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Tuesday, May 23, 2023

SAN DIEGO and GAINESVILLE, Ga., May 23, 2023 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO”; Nasdaq: SCTL ), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has been selected by Atossa Therapeutics (Nasdaq: ATOS ) to provide a range of its Clinical Trial Services (CTS) offerings focused on Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen.

Key Points: 
  • SAN DIEGO and GAINESVILLE, Ga., May 23, 2023 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO”; Nasdaq: SCTL ), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has been selected by Atossa Therapeutics (Nasdaq: ATOS ) to provide a range of its Clinical Trial Services (CTS) offerings focused on Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen.
  • The agreement spans a range of activities including analytical method transfer/development and validation, cleaning verification method validation, manufacturing of multiple R&D engineering batches, and stability testing of the R&D engineering batches.
  • “Societal’s demonstrated expertise in the technology transfer of established drug products, along with our long track record of successfully formulating and manufacturing innovative small molecules, positions us well to align with Atossa and support the ongoing clinical development of the company’s proprietary oral formulation of (Z)-endoxifen.
  • We are eager to initiate this important work and deliver exceptional results for Atossa,” said David Enloe, chief executive officer of Societal CDMO.

Physician-Scientist Dr. Steven Quay Provides Recommendations to the United States Preventive Services Task Force on Breast Cancer Screening Policies and Practices

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Thursday, May 11, 2023

SEATTLE, May 11, 2023 /PRNewswire/ -- Physician-Scientist Dr. Steven Quay, MD, PhD has provided a set of recommendations to the United States Preventive Services Task Force (USPSTF) following the publication of their draft report on breast cancer screening.

Key Points: 
  • SEATTLE, May 11, 2023 /PRNewswire/ -- Physician-Scientist Dr. Steven Quay, MD, PhD has provided a set of recommendations to the United States Preventive Services Task Force (USPSTF) following the publication of their draft report on breast cancer screening.
  • The draft recommendations were made available for public comment on May 9, 2023 and can be found here: Breast Cancer: Screening .
  • Dr. Quay has spent the last decade conducting research on breast cancer, including its prevention, and has 71 patents and patent applications related to his work.
  • High breast density is a known, modifiable risk factor for future breast cancer as well as reducing the sensitivity of mammography for breast cancer detection.

Atossa Therapeutics and Quantum Leap Healthcare Announce New Study Arm to Evaluate (Z)-Endoxifen in the Ongoing I-SPY 2 Clinical Trial

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Tuesday, March 21, 2023

"Data from this trial will supplement data generated through our ongoing Phase 2 EVANGELINE trial, which is investigating (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with ER+ / HER2- breast cancer.

Key Points: 
  • "Data from this trial will supplement data generated through our ongoing Phase 2 EVANGELINE trial, which is investigating (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with ER+ / HER2- breast cancer.
  • The Karisma-Endoxifen trial is a randomized, double-blind, placebo-controlled efficacy study of oral (Z)–endoxifen in premenopausal women with measurable breast density.
  • Atossa will supply (Z)-endoxifen and provide financial support to Quantum Leap for this study.
  • Quantum Leap, as sponsor, will provide the clinical sites and clinical expertise.