SEATTLE - Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company, in partnership with Quantum (NASDAQ:QMCO) Leap Healthcare Collaborative, announced the commencement of a new study to assess the efficacy of Atossa's proprietary (Z)-endoxifen in combination with Eli Lilly (NYSE:LLY)'s abemaciclib in treating ER+/HER2- breast cancer. The study will involve approximately 20 women diagnosed with this subtype of invasive breast cancer.
Participants will undergo a 24-week treatment regimen combining 40mg of (Z)-endoxifen once daily with 150mg of abemaciclib twice daily before their surgical procedures. This combined approach aims to tackle the challenge of treating women with less proliferative tumors, which often carry a high risk of late recurrence despite current hormonal or chemotherapy treatments.
Dr. Laura Esserman, director of the UCSF Breast Care Center and founder of Quantum Leap Healthcare Collaborative, emphasized the need for new treatment combinations in the pre-surgery setting. Dr. Steven Quay, President and CEO of Atossa, expressed optimism based on promising data that suggests (Z)-endoxifen can halt or even reduce tumors, as observed by MRI imaging.
The study aims to provide insights into the suitability of mono versus combination therapy in the neoadjuvant setting and may inform future exploration of this combination in advanced-stage and metastatic breast cancer.
(Z)-endoxifen, a potent Selective Estrogen Receptor Modulator (SERM), is known for its estrogen receptor inhibition and has shown efficacy in patients resistant to other hormonal treatments. It has been well tolerated in Phase 1 studies and is currently under investigation in four Phase 2 trials.
Quantum Leap, responsible for conducting the study, will collaborate with Atossa and Eli Lilly, who will each supply their respective study drugs. The study is part of the ongoing I-SPY 2 Endocrine Optimization Pilot Protocol, which targets newly diagnosed ER+ patients predicted to be responsive to endocrine therapy but unlikely to benefit from chemotherapy.
The information in this article is based on a press release statement from Atossa Therapeutics, Inc.
InvestingPro Insights
Atossa Therapeutics (NASDAQ:ATOS), while advancing its clinical studies, presents a mixed financial landscape according to recent InvestingPro data. The company's market capitalization stands at $208 million, reflecting its position in the biopharmaceutical industry. Despite a challenging profitability outlook, with an adjusted Price/Earnings (P/E) ratio for the last twelve months as of Q4 2023 at -7.56, Atossa has demonstrated significant price momentum. The one-year price total return as of recent data is an impressive 138.1%, highlighting investor optimism potentially spurred by its clinical developments and strategic partnerships.
InvestingPro Tips suggest that while Atossa holds more cash than debt, a strength for financial flexibility, it suffers from weak gross profit margins and is not expected to be profitable this year. However, the company has seen a strong return over the last month, three months, and six months, with respective total returns of 35.66%, 92.29%, and 165.11%. This suggests that despite profitability challenges, the market is responding positively to Atossa's potential in the biopharmaceutical space.
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