Atossa (ATOS) Reports Positive Results From EVANGELINE Study

Atossa Therapeutics, Inc. ATOS recently announced promising safety and efficacy data from the company’s Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) clinical trial.

(Z)-endoxifen is being assessed as a neoadjuvant treatment for premenopausal women with Grade 1 or 2 Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer as part of the EVANGELINE research.

More on the EVANGELINE Study

In Phase 2 EVANGELINE study, participants are likely to receive neoadjuvant treatment for up to six months, followed by surgery. The study is expected to enroll approximately 175 patients at up to 25 sites across the United States.

The main goal of the EVANGELINE trial is to ascertain the impact of (Z)-endoxifen medication on the proliferation of tumor cells and how this trial differs from that of the current standard of care, exemestane + goserelin.

Changes in Ki-67 levels are probably the best way to assess clinical improvement across treatment arms. An often-utilized indicator of cellular development and proliferation in breast cancer tissue is Ki-67. Data from a previous phase 2 study showed that treatment with (Z)-endoxifen reduced Ki-67 by 65.1%, which is clinically meaningful as reducing Ki-67 improves long-term survival for ER+ breast cancer patients.

More on the Results

The data is obtained from the EVANGELINE study's 40 mg pharmacokinetic (PK) run-in cohort. During the 28-day treatment, seven women were included in the cohort. Six of the seven patients who had Ki-67 levels less than 10% at 28 days continued receiving treatment for an extra five months. The seventh patient stopped receiving medication and underwent surgery in accordance with the trial protocol. The patient’s Ki-67 dropped 19% but remained more than 10%.

Among the six patients who were treated for a total of 24 weeks in the EVANGELINE study, magnetic resonance imaging (MRI) central review demonstrated target lesion reduced in all patients with one complete response, one partial response and four stable disease per Response Evaluation Criteria in Solid Tumors criteria. Data from the study showed that the treatment led to a reduction in Ki-67 of 63% at 28 days and 92% at 24 weeks. The average target lesion decrease was 32% at 12 weeks and 37% at 24 weeks of the study.

The 40mg EVANGELINE result is very positive because it demonstrated that (Z)-endoxifen could reduce or completely eradicate the tumor, as determined by MRI imaging, in addition to stopping the growth of ER+ breast cancer.

More on (Z)-endoxifen

(Z)-endoxifen is the most effective selective estrogen receptor modulator when it comes to inhibiting estrogen receptors and degrading them. Additionally, it has demonstrated benefits when used in patients who have tumor resistance to previous hormonal therapies.

Though blood concentrations can be clinically achieved, (Z)-endoxifen has demonstrated the ability to target PKCβ1, a known oncogenic protein, in addition to its strong anti-estrogen actions.

In conclusion, as compared to traditional therapies such as tamoxifen, (Z)-endoxifen appears to have equivalent or perhaps stronger bone agonistic actions with little to no endometrial proliferative effects.

Comparison With Peers

AstraZeneca AZN and partner Daiichi Sankyo recently announced that the FDA had accepted their biologics license application (BLA) seeking approval of the antibody-drug conjugate, datopotamab deruxtecan (Dato-DXd), for a breast cancer indication.

AstraZeneca and Daiichi Sankyo are jointly developing Dato-DXd. AstraZeneca/Daiichi Sankyo are also seeking approval of Dato-DXd for advanced nonsquamous non-small cell lung cancer (NSCLC). A BLA for the NSCLC indication is under review with the FDA.

Accuray Incorporated ARAY recently announced that new data presented at the 2024 Radiosurgery Society Meeting in Chicago supports the use of the CyberKnife System in the treatment of high-risk and recurrent prostate cancer.

The CyberKnife, along with Accuray's proprietary Synchrony technology, detects movement in the prostate during treatment and instantly synchronizes the treatment delivery beam to the tumor's new location in real-time. Accuray’s CyberKnife System has strong potential as the company continues to leverage its potential in its precision Treatment Planning System and radiosurgery market.

Myriad Genetics, Inc. MYGN recently announced the issuance of a patent by the U.S. Patent and Trademark Office, which will strengthen its ability to deliver a tumor-informed, high-definition, molecular residual disease (MRD) assay to the market.

Myriad Genetics’ patented method describes a key aspect of tumor-informed MRD assays that detect circulating tumor DNA (ctDNA) through sequencing. Specifically, it relates to the manner in which a sample is sufficiently enriched with ctDNA so that it can be detected, if present, with high sensitivity and specificity.

The Precise MRD assay leverages MYGN’s existing technology, laboratory systems and processes, infrastructure and intellectual property and builds upon its FDA-approved MyChoice companion diagnostic and FirstGene platforms.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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