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Athenex Announces Initiation of a Phase I/II Clinical Study of Oraxol in Combination with Anti-PD1

BUFFALO, N.Y., Nov. 26, 2018 (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 it has initiated a Phase I/II clinical study to assess the safety, tolerability and activity of Oraxol in combination with an anti-PD1 antibody (pembrolizumab) in patients with advanced solid malignancies, in collaboration with Mayo Clinic.

Oraxol is an innovative oral formulation of paclitaxel, a very effective and commonly used anti-cancer chemotherapy, combined with HM30181A, a novel gastrointestinal tract specific P-glycoprotein pump inhibitor. Pembrolizumab is a checkpoint inhibitor approved by the United States Food and Drug Administration (FDA). 

The study (KX-ORAX-011) is a Phase I/II study being conducted in patients with urothelial, gastric/gastroesophageal or non-small cell lung cancer that have previously failed treatment with a checkpoint inhibitor. The primary outcome measures are tumor response rate and determination of maximum tolerated dose, while the secondary outcome measures include progression free survival, overall survival, duration of response and pharmacokinetics.

Dr. Rudolf Kwan, Chief Medical Officer of Athenex, commented, “Oraxol has an excellent pharmacokinetic profile. Early studies showed that Oraxol, given without concomitant steroids, has the potential to offer a better efficacy and safety profile when compared with traditional intravenous paclitaxel. We are excited to test the hypothesis that a combination of Oraxol with checkpoint inhibitors will achieve a good efficacy and safety profile in patients who have already failed prior checkpoint inhibitor treatment.”
               
Dr. Johnson Lau, Chief Executive Officer of Athenex, stated, “The recent approval by the FDA of an anti-PD1 drug in combination with carboplatin and paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer serves as recognition of the synergy of immunotherapy in combination with chemotherapeutic drugs. We believe that Oraxol may be an excellent choice in combination with cancer immunotherapy and success in this study could be a major milestone, reinforcing the Company’s commitment to delivering safe and effective innovative therapies to cancer patients.”

For more information about the study, please visit https://www.clinicaltrials.gov/ct2/show/NCT03588039?term=Oraxol&rank=7.

Oraxol is currently also being tested in combination with ramucirumab (an anti-VEGF-R2 monoclonal antibody) in a Phase I/II study in patients with gastric cancer. Athenex reported earlier in the year the encouraging results in the first cohort of patients.

The Orascovery platform was developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery and development 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 platform technologies: (1) Orascovery, based on non-absorbed P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell receptor-engineered T-cells (TCR-T), 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. Athenex has offices in Buffalo and Clarence, New York; Cranford, New Jersey; Houston, Texas; Chicago, Illinois; Hong Kong; Taipei, Taiwan and multiple locations in Chongqing, China. For more information, please visit www.athenex.com.

Forward-Looking Statement
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,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “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: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, manufacturing and commercialization; our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and need to raise additional capital to continue as a going concern; competition; intellectual property risks; risks relating to doing business in China; 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
Investor Relations:
Tim McCarthy
Managing Director, LifeSci Advisors, LLC
Tel: +1 716-427-2952 
Direct: +1 212-915-2564

Athenex, Inc.:
Randoll Sze
Chief Financial Officer
Email: randollsze@athenex.com 

Jacqueline Li
Corporate Development and Investor Relations
Email: jacquelineli@athenex.com

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Athenex, Inc.