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Pharma & Biotech

Atossa Therapeutics’ breast cancer drug milestone sparks investor enthusiasm

Atossa Therapeutics Inc (NASDAQ:ATOS) shares continued to move higher on Wednesday, buoyed by the news that a patient with pre-menopausal breast cancer had successfully completed a five-year treatment using its investigative breast cancer therapy (Z)-endoxifen.

Shares of the biotechnology company added 5% at $1.63 late morning Wednesday. The stock is up 32.5% week-over-week.

The company yesterday revealed the treatment results. It highlighted that the patient, who was diagnosed with Estrogen Receptor positive (ER+)/Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer, remains cancer-free with no significant safety or tolerability issues reported during the treatment.

The patient was treated with (Z)-endoxifen, Atossa Therapeutics’ selective estrogen receptor modulator, under the US Food and Drug Administration’s expanded access program, which allows patients to make use of investigational drugs outside of a clinical trial setting.

Atossa Therapeutics is also advancing (Z)-endoxifen through clinical trials, targeting multiple stages of the breast cancer continuum.

It will present data from the 40mg pharmacokinetic run-in cohort of its ongoing Phase 2 EVANGELINE study at the American Association for Cancer Research Annual Meeting being held in San Diego, California, from April 5 to 10.

This trial is evaluating (Z)-endoxifen as a neoadjuvant treatment for premenopausal women diagnosed with ER+/HER2- breast cancer.

Meanwhile, in a separate Phase 2 trial, the company is targeting ductal carcinoma in situ (DCIS), which is considered one of the earliest forms of breast cancer. It is non-invasive and has a low risk of becoming invasive, however, the current standard of care treatments are aggressive, including surgery, radiation therapy and/or hormone therapy.

This study was designed to offer women diagnosed with DCIS up to six months of neoadjuvant endocrine therapy to determine their suitability for long-term active surveillance without surgery. It aims to enroll up to 110 patients, with the first patient in the study dosed in February 2024.

Atossa Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.

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