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Athenex Presents Interim Data from Oral Paclitaxel Phase II Study in Cutaneous Angiosarcoma at ASCO20 Virtual Scientific Program

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BUFFALO, N.Y., May 29, 2020 (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, today presented interim data from an ongoing Phase II clinical trial in which oral paclitaxel and encequidar ("Oral Paclitaxel", formerly known as Oraxol) monotherapy showed encouraging efficacy and tolerability in elderly patients with unresectable cutaneous angiosarcoma, an aggressive malignancy with poor prognosis. The interim results are being presented at the American Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program, being held from May 29 to 31, 2020, and reflect data from 22 evaluable patients out of 26 enrolled patients (16 males and 10 females, median age 75 years (range: 49-93 years)).

The interim data showed a clinical benefit rate (CR+PR+SD) of 100% in 22 evaluable patients receiving Oral Paclitaxel treatment, who reached their first post treatment efficacy evaluation. All 22 patients experienced reduction in tumor size. Complete responses (CR) were observed in 27.3% of patients (6/22), partial responses (PR) were observed in 22.7% of patients (5/22), and stable disease was observed in 50% of patients (11/22). Oral Paclitaxel has been generally well tolerated in this predominantly elderly population.

"The responses to Oral Paclitaxel observed thus far are very encouraging, especially given the highly aggressive nature of cutaneous angiosarcoma and the lack of approved treatment options for this disease," said lead investigator Vinod Ravi, MD, MBA, associate professor in the Department of Sarcoma Medical Oncology in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston, Texas. "Oral Paclitaxel appears to be well tolerated, even in older patients. We look forward to continue advancing the study, which will allow us to further characterize this potentially valuable treatment option for angiosarcoma."

Dr. Rudolf Kwan, Chief Medical Officer of Athenex, commented, "The interim data in this Phase II trial add to the growing body of evidence supporting the potential broad clinical utility of Oral Paclitaxel, which has already shown strong clinical data in a Phase III pivotal trial in patients with metastatic breast cancer."

The interim Phase II data, presented as Poster #11517 A Phase II Study of Oral Paclitaxel with Encequidar in the Treatment of Unresectable Cutaneous Angiosarcoma will be part of the Sarcoma Highlights Session on Sunday, May 31 at 3:30pm ET, at the ASCO20 Virtual Scientific Program. A copy of the poster presentation is available on Athenex's website here.

About the Phase II Study of Oral Paclitaxel in Angiosarcoma

This single-arm Phase II study evaluates the activity, safety and tolerability of Oral Paclitaxel administered once daily for three consecutive days per week in patients with unresectable cutaneous angiosarcoma. Enrollment is ongoing at sites in the U.S., United Kingdom, Hong Kong and Taiwan, with a planned total enrollment of 43 subjects. For more information, refer to ClinicalTrials.gov Identifier: NCT03544567.

In April 2018, the U.S. Food and Drug Administration granted an Orphan Drug Designation for Oral Paclitaxel for the treatment of angiosarcoma. In addition, in October 2019, the Company received Orphan Designations from the European Commission for oral paclitaxel and encequidar for the treatment of soft tissue sarcoma.

The Orascovery platform, based on P-gp pump inhibition technology, was initially 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, 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 platform technologies: (1) Orascovery, based on 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; multiple locations in Chongqing, China; Manchester, UK; Guatemala City, Guatemala and Buenos Aires, Argentina. For more information, please visit http://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, 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; risks and uncertainties related to the COVID-19 pandemic and its potential impact on our operations, cash flow and financial condition; our ability to integrate CIDAL's assets into our existing operations; competition; intellectual property risks; risks relating to doing business internationally and in China; the uncertainty of when, if at all, we will be able to resume full API production operations in Chongqing; 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
Athenex, Inc.:
Jacqueline Li
Corporate Development and Investor Relations
Email: JacquelineLi@athenex.com

Investor Relations:
Tim McCarthy
Managing Director, LifeSci Advisors, LLC
Direct: 212-915-2564

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