One in eight women will be diagnosed with breast cancer during their lifetime. However, breast cancer does not affect all women in the same way, and individual physiology plays a huge factor. Women with dense breast tissue face a higher risk of developing breast cancer and being diagnosed with later-stage disease. The global breast cancer treatment market was worth $31.9 billion in 2022 and is expected to reach a value of $85.5 billion by 2032, growing at a compound annual growth rate of 10.3% over the ten-year period. 50% of women have dense breast tissue, and as such there is a significant unmet need.

Breast cancer remains a widely recognized type of cancer, but it is important to stress that there is still a lot of work ahead in terms of prevention and treatment. In 2022 alone, there were an estimated 287,850 new cases of invasive breast cancer and 51,400 cases of DCIS diagnosed in women across the United States. Tragically, around 43,250 women lost their lives to breast cancer. These figures highlight the urgent need for continued efforts in combating this disease and finding effective solutions. Atossa Therapeutics (NASDAQ:ATOS) is working hard to do just that. 

ER+ breast cancer is the most common type of breast cancer. It is characterized by the presence of estrogen receptors on cancer cells, which causes the cancer cells to grow in response to estrogen 12. According to the U.S. National Cancer Institute, around 80% of all invasive breast cancers are ER-positive.

A new drug, (Z)-endoxifen, has shown promising potential in the treatment of ER+ breast cancer. It belongs to a class of targeted therapies called selective estrogen receptor modulators (SERMs) which help block estrogen and stop the cancer from spreading. What sets (Z)-endoxifen apart from other SERMs is its ability to specifically target a protein called PKCβ1, known to promote cancer growth. This drug has the ability to block all estrogen in a patient, including premenopausal women, without the need for additional medications.

What also makes (Z)-endoxifen unique is its ability to potentially work in all three areas of the Breast Cancer Paradigm: the prevention window, neoadjuvant phase and adjuvant phase. The drug can reduce the density of breast tissue to mitigate the risk of developing breast cancer. In addition, it can reduce cancer cell activity before surgery and also the risk of recurrent or new breast cancer post-initial treatment. This is rare, as most existing drugs like AstraZeneca’s (NASDAQ:AZN) tamoxifen only target one phase.

Researchers at Atossa Therapeutics are working diligently to harness the drug's full potential across all three phases of the paradigm. The standard treatments for breast cancer include surgery, radiation and/or chemotherapy. However, long-term drug therapy is also being researched to reduce the risk of new or recurrent cancer. If successful, (Z)-endoxifen could emerge as a unique and promising treatment option in the fight against breast cancer.

The company has obtained Health Canada's approval to commence the EVANGELINE study, a phase 2 clinical trial that focuses on a promising new treatment for pre-menopausal women with breast cancer. What makes this study different is its investigation of the combination therapy involving (Z)-endoxifen versus the conventional regimen of exemestane and goserelin as neoadjuvant treatment.

Atossa is a well-funded company that seems well-positioned to address the significant unmet need of breast cancer patients with elevated breast density and help with breast cancer treatment throughout the cancer’s progression, not just at one stage. With breast cancer being the second leading cause of cancer death in American women, the company’s drug pipeline could be key to the advancement of breast cancer treatment.

Featured photo by Susan G. Komen 3-Day on Unsplash.