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Athenex Announces Promising Early and Complete Response Data from a Clinical Study of Oraxol in Cutaneous Angiosarcoma

Preliminary data show rapid, visible response to Oraxol monotherapy in the first seven subjects, including three complete responses

BUFFALO, N.Y., May 03, 2019 (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 preliminary data showing promising early clinical responses in the first part of a two part study of Oraxol (oral paclitaxel and encequidar, also known as HM30181A) monotherapy in patients with unresectable cutaneous angiosarcoma.

To date, 10 patients have been enrolled in the clinical study, which is being conducted in four sites in the U.S. and Hong Kong. The first 7 patients have received at least six weeks of treatment, which is the timepoint for the first response assessment; 3 patients have not yet reached the first assessment timepoint. Oraxol is being administered once daily for three consecutive days every week during the treatment period.

All 7 patients showed significant and visible reduction of the cutaneous angiosarcoma within one or two weeks of treatment. Three patients had complete responses based on RECIST v1.1 criteria, with two complete responses occurring by 6 weeks of treatment.

Selected images showing early visible response in one week, from a patient with complete response (Patient A) are available at

http://www.globenewswire.com/NewsRoom/AttachmentNg/d1f1371f-7086-451e-99da-c4c8eeecbf64

http://www.globenewswire.com/NewsRoom/AttachmentNg/38c102f2-0bf7-44e6-aae7-2515b09e8887

http://www.globenewswire.com/NewsRoom/AttachmentNg/f69c732f-6d5b-4b9a-b64b-06307f265bd4

Selected images showing a patient with complete response after 6 weeks of treatment (Patient B) are available at

http://www.globenewswire.com/NewsRoom/AttachmentNg/e30decf6-d6a3-4d5e-8289-e163a4bb8f9a

http://www.globenewswire.com/NewsRoom/AttachmentNg/9d565685-8c14-40e2-bb5f-a5f8162bd3ea

None of the patients enrolled have discontinued treatment due to death, disease progression, or adverse events. No peripheral neuropathy has been reported.

Based on the preliminary data, the study has met the criteria required to proceed to full enrollment.

Dr. Rudolf Kwan, Chief Medical Officer of Athenex, stated, “I am impressed by the rapid clinical response to Oraxol monotherapy treatment in this group of difficult-to-treat patients. The high response rate observed, including three patients who had early complete response, is consistent with the hypothesis that oral delivery of paclitaxel can potentially achieve a more desirable pharmacokinetic profile and a better clinical outcome. I believe the good tolerance of Oraxol in this older patient population would be welcome by both clinicians and patients. This may represent a paradigm shift in the treatment of patients with cutaneous angiosarcoma.”

Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex, commented, “The consistently high response rate observed in various clinical settings, including in the treatment of metastatic breast cancer, unresectable gastric cancer, and now cutaneous angiosarcoma, highlight the potential of Oraxol as an effective therapeutic for a broad range of cancers. With results showing high response rates, lack of significant neuropathy and oral convenience with no need for concomitant use of intravenous steroid pre-treatment, I believe Oraxol also has the potential to transform treatment regimens that use a high potency chemotherapeutic agent in combination with other newly developed anti-cancer therapeutics. We are already evaluating the combination of Oraxol with ramucirumab and Oraxol with an anti-PD1 (pembrolizumab) in clinical studies.”

Oraxol (oral paclitaxel and encequidar, or HM30181A) was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of angiosarcomas in April 2018.

The clinical trial, designed and led by Principal Investigator Vinod Ravi, M.D., associate professor of Sarcoma Medical Oncology at The University of Texas MD Anderson Cancer Center, is open at MD Anderson in Houston, Fred Hutchinson Cancer Center in Seattle and Prince of Wales Hospital, Shatin, in Hong Kong. For more details about the clinical study, please visit ClinicalTrials.gov at https://clinicaltrials.gov/ct2/show/NCT03544567.

Athenex is completing a Phase III clinical trial of Oraxol in the treatment of metastatic breast cancer. In April 2019, the company presented an abstract on preclinical data of oral paclitaxel and HM30181A (encequidar) in angiosarcoma at the American Association of Cancer Research Annual Meeting 2019 in Atlanta, Georgia. In December 2018, Athenex announced positive second cohort results of Oraxol-plus-ramucirumab Phase 1b clinical trial in gastric cancer (more details can be found here). In October 2018, Athenex presented encouraging clinical trial efficacy and safety results of Oraxol in the treatment of metastatic breast cancer in a Phase II clinical trial in Taiwan at ESMO 2018 (more details can be found here).

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

About Angiosarcoma
Angiosarcomas are a type of soft tissue sarcoma characterized by rapidly proliferating, extensively infiltrating, anaplastic cells derived from blood and lymphatic vessels. Angiosarcomas arise in various body sites, including cutaneous, soft tissue, and visceral locations. Angiosarcomas are frequently metastatic at diagnosis, with a natural history complicated by local recurrence, distant metastases, and poor overall survival. Angiosarcomas represent about 2% of soft tissue sarcomas and 5.4% of cutaneous soft tissue sarcomas.

There is no approved treatment for angiosarcoma and survival is limited with treatments currently available. However, reports in the literature of objective tumor response support the use of intravenous paclitaxel in the treatment of angiosarcoma.

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 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 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,” “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; 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 

Athenex, Inc.