Athenex Provides Update from FDA Type A Meeting Regarding Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast Cancer
Athenex, Inc. (NASDAQ: ATNX) announced a Type A meeting with the FDA in Q2 2021 to address issues raised in a February Complete Response Letter regarding oral paclitaxel and encequidar for metastatic breast cancer. The FDA showed support for the continued development of these therapies and agreed that a well-conducted trial could resolve the deficiencies noted in the CRL. Athenex plans to formulate a clinical study design to present to the FDA in Q4 2021. The company is also working on the same drugs for cutaneous angiosarcoma and received Orphan Drug Designation for both the FDA and the European Commission.
- FDA showed support for further development of oral paclitaxel and encequidar.
- Athenex intends to propose a well-designed clinical study to address FDA concerns.
- Received Orphan Drug Designation for treatments related to cutaneous angiosarcoma and soft tissue sarcoma.
- Complete Response Letter indicated deficiencies that need to be addressed before advancing.
BUFFALO, N.Y., July 06, 2021 (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 that the Company held a Type A meeting with the U.S. Food and Drug Administration (FDA) during the second quarter of 2021 to discuss the deficiencies raised in the Complete Response Letter (CRL) received in February.
At the meeting, Athenex provided additional analyses, including overall survival (OS) data on patient subgroups, to provide a more comprehensive summary of the risk/benefit assessment. Athenex also proposed to collect additional OS data that could inform the design of a new clinical study.
The FDA was supportive and encouraged the Company to continue development of oral paclitaxel and encequidar for the treatment of metastatic breast cancer. The FDA also agreed that a well-designed and well-conducted trial may adequately address the deficiencies raised in the CRL. Athenex is evaluating the optimal design for a new clinical study which it intends to present to the FDA in the fourth quarter of 2021.
“We appreciate the FDA’s support for the development of oral paclitaxel and encequidar in this meeting and expect to maintain a collaborative dialogue on this program,” said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. “We continue to believe that, if approved, oral paclitaxel and encequidar has the potential to address a major unmet need in metastatic breast cancer. We hope to agree on a program that is capital efficient and will result in value creation for our stakeholders.”
Athenex is also developing oral paclitaxel and encequidar for the treatment of cutaneous angiosarcoma, for which it has received Orphan Drug Designation from the FDA. Athenex also received Orphan Designations from the European Commission for oral paclitaxel and encequidar for the treatment of soft tissue sarcoma.
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 drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform, and a Global Supply Chain Platform. The Company’s current clinical pipeline is derived from four different technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) Cell therapy, and (4) Arginine deprivation therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active 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 “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” 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: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals; our ability to agree with the FDA on a new clinical study for oral paclitaxel that is capital efficient; our ability to scale our manufacturing and commercial supply operations for current and future approved products, and ability to commercialize our products, once approved; 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 preclinical and clinical results for Athenex’s drug candidates, which may not support further development of such drug candidates; risks related to counterparty performance, including our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and our need and ability to raise additional capital; uncertainties around our ability to meet funding conditions under our financing agreements and access to capital thereunder; risks and uncertainties inherent in litigation, including purported stockholder class actions; risks and uncertainties related to the COVID-19 pandemic and its potential impact on our operations, supply chain, cash flow and financial condition; competition; intellectual property risks; uncertainties around our ability to successfully integrate acquired and merged businesses in a timely and cost-effective manner and to achieve synergies; 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 facilities; 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.
CONTACTS
Investors
Daniel Lang, MD
Athenex, Inc.
Email: danlang@athenex.com
Tim McCarthy
LifeSci Advisors, LLC
Email: tim@lifesciadvisors.com
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