ATOS

On March 21, Atossa announced that Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, will be evaluated in a new study arm of the ongoing I-SPY 2 clinical trial. The I-SPY 2 TRIAL evaluates neoadjuvant treatments for locally advanced breast cancer and is a collaborative effort among academic investigators from major cancer research centers across the United States, Quantum Leap Healthcare Collaborative, the U.S. Food and Drug Administration, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium. Approximately 20 patients will be treated with (Z)-endoxifen for up to 24 weeks prior to surgery. The new study arm evaluating (Z)-endoxifen is part of the ongoing I-SPY 2 Endocrine Optimization Pilot Protocol (EOP), which targets patients with newly diagnosed estrogen receptor-positive (ER+) invasive breast cancer whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit. These patients have substantial risk for recurrence, often after five years, and need novel agents that are more tolerable and effective than the current standard of care and address the risk of recurrence.

On Feb. 13, Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet need in cancer, announced that the United States Patent and Trademark Office (USPTO) has granted a new patent (No. 11,572,334) directed to (Z)-endoxifen encapsulated in an enteric capsule. Enteric capsules have an acid resistant coating to prevent them from dissolving when they pass through the stomach. Enteric capsules are dissolved when they pass through an alkaline environment, which is usually when they reach the small intestine. Delivering oral (Z)-endoxifen via an enteric capsule prevents breakdown of the endoxifen in the stomach. This patent further reinforces Atossa’s broad Intellectual Property portfolio related to (Z)-endoxifen. A short ‘explainer’ video about the new patent can be found here: https://youtu.be/MrcEYp4Pptc

Dr. Steven Quay, Atossa’s President and Chief Executive Officer stated, “We are very pleased with the scope and breadth of this new key patent. It ensures that in the U.S., Atossa will have the only (Z)-endoxifen treatment delivered orally with an enteric capsule, which we believe is the optimal way to deliver the drug. This new patent, further strengthens our intellectual property estate and should create long-term stockholder value. There are a number of research-level medical applications of endoxifen outside of breast cancer, including in bipolar disorder disease in adults and in modulating genetically modified, cell-based therapies for cancer and immune diseases, that may require access to our endoxifen patents and technologies. Atossa will monitor these activities carefully as they approach commercialization, with an eye to establishing appropriate licensing arrangements for the benefit of Atossa shareholders.”

Atossa’s trials seek to address significant unmet medical need in breast cancer. While there are several FDA-approved neoadjuvant therapies for ER- breast cancers, few good options exist for ER+ patients, which account for approximately 78% of breast cancers. Current treatment approaches for premenopausal women diagnosed with ER+ breast cancer include ovarian suppression, which can induce menopause and dramatically impact a patient’s quality of life. Additionally, MBD affects more than 10 million women in the United States and many millions more worldwide. Increased MBD reduces the ability of mammograms to detect cancer. Studies have also shown that women with MBD have an increased risk of developing breast cancer and that the higher the MBD, the higher the incidence of breast cancer.

Atossa’s trials include the following:

Phase 2 “EVANGELINE” study – (Z)-endoxifen and exemestane + goserelin as neoadjuvant treatment in premenopausal women with ER+/HER2- breast cancer. The EVANGELINE trial is expected to enroll approximately 175 patients at up to 25 sites across the United States and builds on an earlier Phase 2 study that showed treatment with (Z)-endoxifen reduced Ki-67, a commonly used measure of cellular proliferation and growth in breast cancer tissue. The EVANGELINE trial will evaluate safety and tolerability of treatment with (Z)-endoxifen, reduction in Ki-67 and pathological response. It will also study whether treatment with (Z)-endoxifen in premenopausal women could provide clinical benefit without the need for ovarian suppression.

Phase 2 “Karisma-Endoxifen” study – (Z)-endoxifen in premenopausal women with elevated mammographic breast density (MBD). This randomized, double-blind, placebo-controlled trial of healthy, pre-menopausal women with increased breast density is expected to enroll 240 study participants. The treatment cohort receives daily doses of (Z)-endoxifen for six months, over the course of which mammograms will be conducted to measure reduction in MBD. Patients will also be given a mammogram at 24 months to assess the durability of the MBD changes.

Approximately one in eight women and one in 1,000 men will be diagnosed with breast cancer during their lifetime. Every two minutes an American woman is diagnosed with breast cancer; 40,000 die each year. The American Cancer Society (ACS) estimates that approximately 270,000 women will be diagnosed with breast cancer in the United States this year. It is the second leading cause of cancer death in American women.  Atossa Therapeutics is developing a drug “(Z)-endoxifen” to reduce mammographic breast density and, for patients who have recently been diagnosed with the most common type of breast cancer, to reduce tumor activity prior to surgery. Study by others have shown that reducing breast density can reduce the risk of breast cancer. (Z)-Endoxifen has the potential to work in all three areas of the Breast Cancer Paradigm: to mitigate breast cancer risk (by reducing the density of breast tissue); to reduce the cancer cell activity before surgery; and to reduce the risk of recurrent or new breast cancer after the initial treatment. Atossa is also developing oral (Z)-endoxifen in the “window of opportunity” between diagnosis of breast cancer and surgery. For these newly diagnosed patients, taking oral (Z)-Endoxifen before surgery may “turn down” the cancer cell activity. (Z)-Endoxifen has been identified as a key tamoxifen metabolite that helps reduce the risk of getting future breast cancer. Studies have shown that increasing the levels of (Z)-endoxifenin breast cancer patients reduces the risk of future recurrence. Atossa’s proprietary Oral form of (Z)-Endoxifen was the subject of a comprehensive Phase 1 clinical study in healthy women in Australia. All objectives from this study were successfully met. In addition, Atossa’s Oral (Z)-Endoxifen was subject of an open-label Phase 2 clinical study administered in the “window of opportunity” between diagnosis of breast cancer and surgery. Positive results were achieved with the patients enrolled.  

Atossa is led by accomplished scientist and entrepreneur, Dr. Stephen Quay, MD, PhD. Dr. Quay has served as Chief Executive Officer, President and Chairman of the Board of Directors of the Company since the Company was incorporated in April 2009. Dr. Quay is certified in Anatomic Pathology with the American Board of Pathology, completed both an internship and residency in anatomic pathology at Massachusetts General Hospital, a Harvard Medical School teaching hospital, and is a former faculty member of the Department of Pathology, Stanford University School of Medicine. Dr. Quay is a named inventor on 87 U.S. patents, 130 pending U.S. patent applications, and is named inventor on patents covering five pharmaceutical products that have been approved by the U.S. Food and Drug Administration. Dr. Quay received an M.D. in 1977 and a Ph.D. in 1975 from the University of Michigan. He received his B.A. degree in biology, chemistry and mathematics from Western Michigan University in 1971. He was selected to serve on the Company’s Board of Directors because of his role as a founder of the Company, as well as his qualifications as a physician and the principal researcher overseeing the clinical and regulatory development of the Company’s pharmaceutical programs. View Dr. Quay’s TedX Talk “How to Be Smart When You’re Dense: Preventing Breast Cancer by 2030.”

As of December 31, 2022, we had cash, cash equivalents and restricted cash of $111,000.  

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