Athenex Announces Clinical Pass – GuruFocus.com

BUFFALO, NY, May 16, 2022 (GLOBE NEWSWIRE) — Athenex, Inc., (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 a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada). Agreement applies to expansion phase of Phase 1 clinical trial evaluating Athenex’s oral paclitaxel in combination with Merck’s anti-PD-1 treatment KEYTRUDA® (pembrolizumab) for certain patients with NSCLC.

The agreement will support the expansion phase of the trial to expand on encouraging preliminary results from the KX-ORAX-011 Phase 1 clinical trial evaluating Oraxol (encequidar plus oral paclitaxel) in combination with pembrolizumab for certain patients with NSCLC. The two companies will form a joint development committee to review clinical trial results.

“We would like to collaborate with Merck to further study the therapeutic potential of Oraxol plus KEYTRUDA® in patients with NSCLC who have progressed on previous anti-PD1/anti-PD-L1 therapy or in combination with chemotherapy,” said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. “If preliminary efficacy and safety data can be confirmed, this could lead to a new paradigm in the treatment of certain patients with NSCLC.”

KX-ORAX-011 is an ongoing Phase 1 trial evaluating Oraxol in combination with pembrolizumab in patients with advanced solid tumors. After completion of the dose escalation phase, the expansion phase is currently evaluating combination therapy in patients with NSCLC who have progressed on prior anti-PD1/anti-PD-L1 therapy or in combination with a chemotherapy. The NSCLC expansion cohort is actively recruiting and aims to enroll approximately 50 patients.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About oral paclitaxel
Athenex’s oral paclitaxel and encequidar (“oral paclitaxel”) are in early development for solid malignancies. Encequidar, the cornerstone of Athenex’s Orascovery technology platform, is a highly specific and potent inhibitor of the transport protein called P-glycoprotein (P-gp) in the gastrointestinal (GI) tract. By localizing P-gp inhibitory activity in the gastrointestinal tract, encequidar enhances the absorption of chemotherapeutic agents while limiting the potential for unnecessary P-gp inhibition at other sites in the body. The potency, selectivity and low absorption of the encequidar allow the oral administration of IV chemotherapies.

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 pursuing this mission, Athenex draws on years of experience in research and development, clinical trials, regulatory standards and manufacturing. The Company’s current clinical pipeline is mainly derived from the following core technologies: (1) Cell Therapy based on NKT cells, (2) Orascovery, based on a P-glycoprotein inhibitor, and (3) Inhibition of Src Kinase . Athenex employees around the world are dedicated to improving the lives of cancer patients by creating more active, accessible and tolerable treatments. For more information, visit www.athenex.com.

Forward-looking statements

Except for historical information, all statements, expectations and assumptions in this press release are forward-looking statements. These forward-looking statements are generally identified by words such as “anticipate”, “believe”, “continue”, “could”, “expect”, “guidance”, “implement”, “intend”, “may”, ” to plan “. , “”current”, “will” and similar expressions. Actual results may differ materially from those expressed or implied in the forward-looking statements. Important factors that could cause actual results to differ materially include: our history of operating losses and our need and ability to raise additional capital to continue our business; our ability to successfully redirect our resources and reduce our operating expenses; our ability to weather uncertainties about our ability to complete new funding agreements as we are unable to meet the terms of funding under our existing funding agreements and access capital thereunder; the stage of development of our lead clinical candidates, including including NKT cell therapy and associated risks related to drug development, clinical trials clinical, regulatory, uncertainties surrounding regulatory reviews and approvals; preclinical and clinical results of 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 to obtain approval of its drug candidates in a timely manner, if at all; risks related to our ability to successfully integrate Kuur’s business into our existing businesses, including uncertainties associated with maintaining relationships with customers, suppliers and employees, as well as differences in operations, cultures and management philosophies that may delay successful integration and our ability to bear the additional cost burden of Kuur’s business; risks relating to the performance of counterparties, including our dependence on third parties to succeed in certain areas of Athenex’s business; risks and uncertainties inherent in litigation, including purported shareholder class actions; risks and uncertainties related to the COVID-19 pandemic and its continued impact on our operations, supply chain, cash flows and financial condition; competition; intellectual property risks; risks related to international business and China; the risk of development, operational delays, production slowdowns or stoppages or other disruptions at our manufacturing facility as well as our ability to secure alternate sources of supply to meet our obligations and requirements; if we enter into a preferred contract manufacturing agreement with ImmunityBio; the risk that our common stock may be delisted from the Nasdaq Global Market if we are unable to restore compliance with its continuous listing standards, and the other risk factors set forth from time to time in our filings with the SEC , copies of which are available free of charge from the Investor Relations section of our website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon request from our Department investor relations. All information provided in this release is as of the date hereof and we undertake no obligation and do not intend to update these forward-looking statements except as required by law.

Athenex contacts

Investors

Daniel Lang, MD
Athens, Inc.
E-mail: [email protected]

Caileigh Dougherty
Athens, Inc.
E-mail: [email protected]

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