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Athenex Announces Publication of Data from Phase 3 Study Comparing Oral Paclitaxel Plus Encequidar Versus Intravenous Paclitaxel in Patients with Metastatic Breast Cancer in the Journal of Clinical Oncology

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Athenex, Inc. (NASDAQ: ATNX) announced the publication of results from its Phase III study comparing oral paclitaxel plus encequidar to intravenous paclitaxel for metastatic breast cancer. The findings indicate improved tumor response with oral administration, along with positive trends in progression-free and overall survival. Reduced neuropathy was also noted, offering a potentially effective at-home treatment option. The company underscores the importance of managing toxicity, particularly in patients with abnormal liver function.

Positive
  • Significantly improved tumor response reported with oral paclitaxel plus encequidar compared to IV administration.
  • Positive trends observed in progression-free survival and overall survival.
  • Less frequent and severe neuropathy associated with oral treatment, enhancing patient comfort.
Negative
  • Potential risks of early neutropenia and infections in patients with elevated liver enzymes.
  • Uncertainties surrounding the company's ability to maintain compliance with Nasdaq listing standards.

BUFFALO, N.Y., July 25, 2022 (GLOBE NEWSWIRE) -- Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced the publication of their manuscript, “Open-Label, Randomized, Multicenter, Phase III Study Comparing Oral Paclitaxel Plus Encequidar Versus Intravenous Paclitaxel in Patients with Metastatic Breast Cancer”. The article, along with results, can be found on the American Society of Clinical Oncology Journal’s website at this link.

“We are pleased with the publication of the phase 3 data, which show that oral paclitaxel plus encequidar significantly improves tumor response in patients with metastatic breast cancer, compared to IV administration. Positive trends were observed in progression free survival and overall survival,” said Hope S. Rugo, MD, Professor of Medicine, University of California San Francisco Comprehensive Cancer Center. “With oral administration of paclitaxel plus encequidar, we observed less frequent and less severe neuropathy, which is often a limiting toxicity with IV taxanes. In patients with abnormal liver function, we identified a predisposition to early neutropenia and infections in patents with elevated liver enzymes at baseline, allowing for better toxicity management moving forward. We believe that for appropriate patients with advanced or metastatic breast cancer, this could potentially be an effective at home treatment option.”

About Athenex, Inc.

Founded in 2003, Athenex, Inc. is a global clinical-stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation cell therapy drugs for the treatment of cancer. In pursuit of this mission, Athenex leverages years of experience in research and development, clinical trials, regulatory standards, and manufacturing. The Company’s current clinical pipeline is derived mainly from the following core technologies: (1) Cell therapy, based on NKT cells and (2) Orascovery, based on a P-glycoprotein inhibitor. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active, accessible and tolerable treatments. For more information, please visit www.athenex.com.

Forward-Looking Statements

Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “continue,” “could,” “expect,” “intend,” “look forward,” “may,” “potential,” “will,” and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: our ability to complete the sale of our equity interests in our China subsidiaries; our history of operating losses and the substantial doubt about our ability to continue as a going concern; our strategic pivot to focus on our cell therapy platform and our plan to dispose of non-core assets; our ability to obtain financing to fund operations, successfully redirect our resources and reduce our operating expenses; our ability to refinance, extend or repay our substantial indebtedness owed to our senior secured lender; the development stage of our primary clinical candidates, including NKT Cell Therapy and related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals; the preclinical and clinical results for Athenex’s drug candidates, which may not support further development of such drug candidates; the Company’s ability to successfully demonstrate the safety and efficacy of its drug candidates and gain approval of its drug candidates on a timely basis, if at all; the uncertainty of ongoing legal proceedings; risks related to our ability to successfully integrate the business of Kuur Therapeutics into our existing businesses, including uncertainties associated with maintaining relationships with customers, vendors, and employees, as well as differences in operations, cultures, and management philosophies that may delay successful integration and our ability to support the added cost burden of Kuur’s business; risks related to counterparty performance, including our reliance on third parties for success in certain areas of Athenex’s business; risks and uncertainties inherent in litigation, including purported stockholder class actions; the impact of the COVID-19 pandemic and other macroeconomic factors, such as the war in Ukraine, and their ongoing impact on our operations, supply chain, cash flow, and financial condition; competition; intellectual property risks; risks relating to doing business internationally and in China; the risk of development, operational delays, production slowdowns or stoppages or other interruptions at our manufacturing facility as well as our ability to find alternative sources of supply to meet our obligations and requirements; the risk that our common stock will be delisted from the Nasdaq Global Market if we are unable to regain compliance with its continued listing standards, and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon request from our Investor Relations Department. All information provided in this release is as of the date hereof, and we assume no obligation and do not intend to update these forward-looking statements, except as required by law.

Athenex Contacts

Investor Relations

Daniel Lang, MD
Athenex, Inc.
E-mail: danlang@athenex.com

Caileigh Dougherty
Athenex, Inc.
E-mail: cdougherty@athenex.com 


FAQ

What were the results of the Athenex Phase III study for metastatic breast cancer?

The study showed that oral paclitaxel plus encequidar significantly improved tumor response compared to intravenous paclitaxel.

What are the implications of the Phase III study for patients with metastatic breast cancer?

The oral treatment may offer a more comfortable at-home option and demonstrate better toxicity management.

What are the next steps for Athenex following the Phase III study publication?

Athenex aims to manage identified risks, particularly in patients with liver function concerns, and to continue developing its oral treatment options.

How might the study results impact Athenex's stock performance?

Positive study results could enhance investor confidence and potentially lead to an increase in stock value based on improved treatment options for metastatic breast cancer.

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