Athenex Announces Data on Oral Paclitaxel and Encequidar to be Presented at the 2020 San Antonio Breast Cancer Symposium (SABCS)

• Spotlight poster on updated PFS and OS data from the pivotal Phase 3 clinical trial of oral paclitaxel in metastatic breast cancer

BUFFALO, N.Y., Nov. 17, 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 and related conditions, announced today that oral paclitaxel and encequidar (“oral paclitaxel”) data will be presented in four separate poster presentations at the 2020 San Antonio Breast Cancer Symposium (SABCS) to be held virtually December 8-11. Presentations will include, from the pivotal Phase 3 clinical trial of oral paclitaxel in metastatic breast cancer (MBC), a spotlight poster on progression-free survival (PFS) and overall survival (OS), and posters on neuropathy (CIPN), and management of gastrointestinal (GI) side effects. An additional poster explores oral paclitaxel in the treatment of cutaneous angiosarcoma of the breast.

The symposium will also feature an immersive Athenex Oncology virtual exhibit experience with distinct hubs for CIPN, Medical Affairs, and the Facing MBC Together program.

Details of the oral paclitaxel presentations are as follows:

Spotlight Poster Presentation

Abstract Title: Oral Paclitaxel and Encequidar (oPac+E) versus IV Paclitaxel (IVPac) in the treatment of metastatic breast cancer (mBC) patients (Study: KX-ORAX-001)

Session: Spotlight Poster Discussion 1

Program Number: PD1-08

Date and Time: Wednesday, December 9, 2020, at 4:00 PM to 5:15 PM Central Time (CT)

For more information, please visit: https://www.sabcs.org/Program/Spotlight-Sessions/Spotlight-Poster-Discussion-1

Abstracts selected for spotlight poster presentation will only have titles posted to the SABCS website until the embargo lifts on December 9, 2020, when the complete abstract will post online.

Additional Poster Presentations

Abstract Title: A phase 2 study of Oral Paclitaxel and Encequidar (oPac+E) in the treatment of cutaneous angiosarcoma: the breast angiosarcoma group

Program Number: PS13-05

Session: Poster Session 13

Date and Time: Wednesday, December 9, 2020, at 8:00 AM CT

For more information, please visit: https://www.sabcs.org/Program/Poster-Sessions/Poster-Session-13

Abstract Title: Lower rates of neuropathy with Oral Paclitaxel and Encequidar (oPac+E) compared to IV Paclitaxel (IVPac) in treatment of metastatic breast cancer (mBC): Study KX-ORAX-001

Program Number: PS13-06

Session: Poster Session 13

Date and Time: Wednesday, December 9, 2020, at 8:00 AM CT

For more information, please visit: https://www.sabcs.org/Program/Poster-Sessions/Poster-Session-13

Abstract Title: Oral Paclitaxel and Encequidar (oPac+E) in the treatment of metastatic breast cancer (mBC): Management of gastrointestinal adverse events (GI AE). Study KX-ORAX-001

Program Number: PS13-11

Session: Poster Session 13

Date and Time: Wednesday, December 9, 2020, at 8:00 AM CT

For more information, please visit: https://www.sabcs.org/Program/Poster-Sessions/Poster-Session-13

Athenex Exhibit Booth

Athenex Oncology will have an immersive virtual exhibit experience at SABCS. This unique booth will feature three separate hubs: 1) Chemotherapy-Induced Peripheral Neuropathy (CIPN) augmented reality simulation, designed to deepen a visitor’s understanding and virtually experience what it feels like to have CIPN; 2) Facing MBC Together, a public education and patient support program that addresses the issue of isolation for people living with metastatic breast cancer; and 3) Medical Affairs, where visitors can learn about how inhibition of P-gp facilitates absorption of orally administered chemotherapies. The booth will be accessible to meeting registrants throughout SABCS during exhibit hall hours, which are from 10am-7pm on Tuesday, December 8; 8am-7:45pm on Wednesday, December 9; and 10am-5pm on Thursday and Friday, December 10 and 11 (all Central Time). 

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 www.athenex.com.

About Oral Paclitaxel
Athenex’s oral paclitaxel and encequidar (“oral paclitaxel”) is the first oral formulation of paclitaxel in late-stage development for the treatment of metastatic breast cancer (MBC), and is also in earlier stages of development for other malignancies. Data from a pivotal phase 3, open-label, randomized, multicenter study involving more than 400 patients with MBC suggests that oral paclitaxel is superior to IV paclitaxel in terms of efficacy (as measured by confirmed tumor response) and tolerability. Encequidar, the cornerstone of Athenex’s Orascovery technology platform, is a highly specific and potent inhibitor of an active transport protein called P-glycoprotein (P-gp) in the gastrointestinal (GI) tract. By localizing P-gp inhibitory activity in the GI tract, encequidar improves the absorption of chemotherapeutic agents while limiting the potential for unnecessary P-gp inhibition at other sites in the body. The potency, selectivity, and non-systemic absorption of encequidar enables the administration of many traditional IV chemotherapies more easily, allowing for greater bioavailability and a potentially longer duration of therapy. On September 1, 2020, Athenex announced that the FDA accepted the Company’s New Drug Application (NDA) for Oral Paclitaxel for the treatment of MBC and granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2021.

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; uncertainties around our ability to meet funding conditions under our financing agreements and access to capital thereunder; risks and uncertainties related to the COVID-19 pandemic and its potential impact on our operations, cash flow and financial condition; competition; intellectual property risks; risks relating to doing business internationally and in China; the risk of production slowdowns or stoppages or other interruptions at our Chongqing facilities; 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

Investors
Steve Rubis
Athenex, Inc.
Email: stevenrubis@athenex.com

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

Media
Gloria Gasaatura
LifeSci Advisors, LLC
Email: ggasaatura@lifesciadvisors.com