SEATTLE - Atossa Therapeutics, Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company, announced today significant protocol amendments to its ongoing Phase 2 EVANGELINE study, which is evaluating the combination of its proprietary (Z)-endoxifen and Eli Lilly (NYSE:LLY)'s abemaciclib as a pre-surgical treatment for Estrogen Receptor positive (ER+)/Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer.
The protocol modifications include an increased (Z)-endoxifen dosage from 40 mg to 80 mg daily, based on encouraging safety and efficacy data from the initial pharmacokinetic (PK) cohort. This cohort exhibited an average reduction in the tumor proliferation marker Ki-67 of 92% and a mean tumor size reduction of 37% after 24 weeks of treatment.
The study will now enroll around 80 participants across two cohorts, each consisting of pre-and-menopausal women, to receive the updated 80 mg dose of (Z)-endoxifen combined with 150 mg of abemaciclib twice daily for up to 24 weeks before surgery. The second cohort will additionally include ovarian function suppression (OFS) in premenopausal women to allow direct comparison of safety and efficacy between the groups.
Dr. Steven Quay, President and CEO of Atossa, expressed enthusiasm for the protocol update and the support from Eli Lilly for the trial. He highlighted the preliminary data affirming the safety profile of the 80 mg (Z)-endoxifen dose and its potential clinical benefit for premenopausal women without the need for OFS.
(Z)-endoxifen, touted as a potent Selective Estrogen Receptor Modulator (SERM), is being developed by Atossa to prevent and treat breast cancer. It has shown efficacy in patients with resistance to other hormonal treatments and is involved in four Phase 2 trials targeting various breast cancer conditions.
This press release statement serves as the basis for the updates to the study, which is a collaborative effort with Eli Lilly, with each company providing their respective study drugs. The modifications aim to optimize the treatment's antitumor efficacy and further establish (Z)-endoxifen's safety and efficacy, particularly in premenopausal women.
In other recent news, Atossa Therapeutics has been making strides in breast cancer research and treatment. The company reported positive outcomes from its Phase 2 EVANGELINE clinical trial, which assessed (Z)-endoxifen as a neoadjuvant treatment for certain types of breast cancer. The trial showed a significant reduction in Ki-67 levels, a marker for tumor growth, in six out of seven participants.
Atossa also announced an expanded research agreement with Weill Cornell Medicine to study the combination of antibody-drug conjugates (ADCs) and (Z)-endoxifen in treating advanced breast cancer. The research aims to investigate the synergy between these drugs, which could potentially enhance anti-tumor effects.
In collaboration with Quantum (NASDAQ:QMCO) Leap Healthcare Collaborative, Atossa launched a new study to assess the efficacy of (Z)-endoxifen in combination with Eli Lilly's abemaciclib in treating ER+/HER2- breast cancer. The study will involve approximately 20 women diagnosed with this subtype of invasive breast cancer.
Furthermore, H.C. Wainwright has increased the price target for Atossa Genetics (NASDAQ:ATOS) to $6.00 from the previous $4.00, maintaining a Buy rating on the stock. This revision follows Atossa's announcement of its first-quarter 2024 financial results and updates on its corporate activities. These recent developments highlight Atossa's continued commitment to advancing breast cancer research and treatment.
InvestingPro Insights
As Atossa Therapeutics, Inc. (NASDAQ: ATOS) advances its clinical trials, investors and stakeholders are keenly observing the company's financial health and market performance. Here are some insights based on the latest data available from InvestingPro:
InvestingPro Data shows that Atossa Therapeutics has a market capitalization of $143.36 million. Despite the company's efforts in advancing its clinical studies, it has a negative P/E ratio of -4.94, indicating that it is not currently profitable. This aligns with the fact that analysts do not anticipate the company will be profitable this year, which is one of the InvestingPro Tips provided for Atossa.
Another key metric is the company's Price / Book ratio, which stands at 1.67 as of the last twelve months. This suggests that the stock is potentially undervalued relative to the company's book value, which could be of interest to value investors.
From a performance standpoint, the stock has experienced a 1-month price total return of -19.72%, reflecting recent market challenges. However, it is noteworthy that the company holds more cash than debt on its balance sheet, which is a positive sign of financial stability and is highlighted as an InvestingPro Tip.
For investors looking for more in-depth analysis and additional insights, there are currently 6 more InvestingPro Tips available for Atossa Therapeutics. These tips could provide valuable context for the company's financial outlook and stock performance.
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