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Athenex Presents Data from Oral Paclitaxel + Pembrolizumab Phase 1 Study at ESMO 2021

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Safety Data Help Establish Part B Dose Expansion and Phase 2 Dose; Data showed encouraging anti-tumor activity (4 PR out of 8 evaluable patients) in NSCLC patients who failed prior PD1/PDL1 therapies

BUFFALO, N.Y., Sept. 16, 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, announced today the presentation of data from a Phase 1 study to assess the safety, tolerability, and activity of oral paclitaxel and encequidar (Oral Paclitaxel) in combination with pembrolizumab in patients with advanced solid malignancies. The data are being presented in a poster presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2021, being held from September 16th to September 21st.

“The encouraging interim Phase 1 data suggest promising anti-cancer activity and expected safety and tolerability observations for oral paclitaxel with pembrolizumab in lung cancer patients who had progressed on PD1/PDL1 therapies,” said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. “PD1/PDL1 therapies are important treatments for lung cancer but most patients eventually progress, and those patients represent an area of high unmet medical need. We are currently working to confirm these data in the dose expansion phase of this study.”

Phase 1 Study with Expansion Cohorts to Assess the Safety, Tolerability, and Activity of Oraxol (Oral Paclitaxel + Encequidar) in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies

The primary objective for the dose escalation phase of the study was to determine the maximum tolerated dose (MTD) and identify the recommended Phase 2 dose (RP2D) of Oral Paclitaxel in combination with pembrolizumab in patients with advanced solid tumors.

The dose escalation phase of the study enrolled 21 patients. Activity data were presented on 17 patients who were evaluable for a response, including eight NSCLC patients as well as patients with head and neck cancer, uveal melanoma, oesophageal cancer, colon cancer and bladder cancer. Four patients had partial response, 10 patients had stable disease, and three patients had progressive disease. The duration on treatment ranged from 9 to 676+ days.

There were a total of 10 NSCLC patients enrolled, of which eight were evaluable for response. Four patients achieved partial response and four patients achieved stable disease. All had discontinued previous checkpoint inhibitor therapy due to progressive disease.

MTD of the combination was not reached. The RP2D in combination with pembrolizumab was selected as Oral Paclitaxel 270 mg QD Days 1-3 for 2 weeks of a 3-week cycle. The study is proceeding to expansion cohorts and will enroll additional patients with NSCLC to further evaluate the safety and clinical activity of Oral Paclitaxel with pembrolizumab.

About the Phase 1 Study of Oral Paclitaxel and Encequidar in Combination with Pembrolizumab

The Phase 1 study is an open-label dose-escalation design study, to be followed by a 2-arm expansion cohort. The dose escalation utilized the “3+3” design and eligible patients had metastatic or unresectable solid tumors for which pembrolizumab is an FDA approved therapy. The Oral Paclitaxel dose range explored was 270-330mg administered for 2 days up to a maximum of 5 days per week x 2 weeks of a 3-week cycle. Pembrolizumab 200mg IV was administered every three weeks. The primary objective for Part A of the study was to determine the maximum tolerated dose (MTD) and identify the recommended Phase 2 dose of Oral Paclitaxel in combination with pembrolizumab in subjects with advanced solid tumors. Secondary objectives included safety and tolerability, the pharmacokinetics of paclitaxel, and preliminary anti-tumor activity. MTD and dose limiting toxicities were determined based on toxicities observed during the first 3-week cycle of treatment. Response was determined by CT scan evaluated by RECIST 1.1 every 9 weeks. The Part B dose expansion phase will enroll subjects with NSCLC to further evaluate the activity, safety and tolerability of the study treatment.

For further information about the study, visit ClinicalTrials.gov, identifier: NCT03588039.

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 and time 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 our ability to successfully integrate the business of Kuur 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; 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 ongoing 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 as well as our ability to find alternative sources of supply to meet our obligations and requirements; 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

Investors

Daniel Lang, MD
Athenex, Inc.
Email: danlang@athenex.com

Caileigh Dougherty
Athenex, Inc.
Email: cdougherty@athenex.com