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Athenex to Host a KOL Webinar Today on CAR-NKT Cell Approach to Cancer and Latest Data at the 63rd ASH Annual Meeting

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Athenex announced a virtual Key Opinion Leader event to discuss its CAR-NKT cell therapy platform today at 9:00 a.m. ET. Interim results from the ANCHOR study on KUR-502 show an impressive 80% Overall Response Rate and 60% Complete Response at lower dose levels. In the study, five patients achieved significant responses, including a recent conversion of a partial response to complete response. The safety profile remains favorable, and enrollment continues. KOLs from Baylor and MD Anderson will present findings and insights during the webinar.

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The Company will host a virtual Key Opinion Leader event today at 9:00 a.m. ET to discuss its CAR-NKT cell therapy platform

Interim results from five evaluable patients in ANCHOR study of KUR-502 showed 80% Overall Response Rate and 60% Complete Response at lowest dose levels

BUFFALO, N.Y., Dec. 13, 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 it will host a virtual Key Opinion Leader (KOL) event today at 9:00am ET to discuss its NKT cell therapy programs.

Athenex had previously announced best responses from five patients of 2 partial responses (PR), 1 complete response with incomplete hematological recovery (CRi) and 1 complete response (CR) from the ANCHOR Phase 1 study of KUR-502 (allogeneic CD19 CAR-NKT cells) in relapsed /refractory lymphoma and leukemia. At the ASH Annual Meeting yesterday, the Company provided updated results from the study, which included a conversion of one patient (NHL-4) treated with dose level (DL) 2, from a PR to a CR. Safety profile of treatment with the allogeneic CAR-NKT cells remains favorable and further enrollment is ongoing.

Register for the KOL webinar on the Investor Relations portion of the website.

The webinar will feature presentations by KOLs Leonid Metelitsa, M.D., and Carlos Ramos, M.D., both from Baylor College of Medicine, and Sattva Neelapu, M.D., from MD Anderson Cancer Center. Dr. Metelitsa will provide an overview of Athenex's CAR-NKT cell-based approaches. Dr. Ramos will discuss the interim data from the ongoing ANCHOR study evaluating KUR-502 in relapsed or refractory lymphoma and leukemia. Dr. Neelapu will discuss the current treatment landscape and unmet medical needs in lymphoma and leukemia.

Presentations from Kurt Gunter, M.D., Chief Medical Officer for Cell Therapy at Athenex, and Daniel Lang, M.D., President of Athenex Cell Therapy, will follow to discuss clinical milestones and company objectives.

A question-and-answer session will follow the formal presentations.

About the Phase I Study of KUR-502 (Allogeneic CD19 CAR-NKT Cells) in Patients with Relapsed or Refractory B-Cell Malignancies (ANCHOR)

The phase I study is an open-label, dose-escalation study. NKT cells were isolated from the leukapheresis product of one HLA-unmatched healthy individual, transduced with the CAR, expanded ex vivo for 14 days (99.8% NKT purity), and cryopreserved. Patients received 107 (DL 1) or 3×107 (DL 2) CAR-NKT cells per square meter of body surface area following lymphodepleting conditioning with cyclophosphamide/fludarabine. Adverse events were evaluated per NCI criteria. When accessible, patients underwent core biopsies of an involved site at 2-5 weeks post-infusion. Response to therapy was assessed at 4 weeks per Lugano Criteria (for NHL) or NCCN guidelines (for ALL).

For further information about the study, visit ClinicalTrials.gov, identifier: NCT03774654.

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 mainly from the following core technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, and (3) Cell 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, including NKT Cell Therapy and related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals; our ability to pivot our business and to find new uses for the capacity at our Dunkirk manufacturing facility, once operational; 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 to continue as a going concern; uncertainties around our ability to enter into new financing agreements as we are unable to meet funding conditions under our existing 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 


FAQ

What were the interim results of the KUR-502 study by Athenex?

The interim results showed an 80% Overall Response Rate and a 60% Complete Response at the lowest dose levels in the ANCHOR study.

When is the Athenex KOL event scheduled?

The Athenex KOL event is scheduled for today at 9:00 a.m. ET.

Who are the KOLs presenting at the Athenex event?

KOLs presenting include Leonid Metelitsa, M.D., Carlos Ramos, M.D., and Sattva Neelapu, M.D.

What is the CAR-NKT cell therapy platform of Athenex?

Athenex's CAR-NKT cell therapy platform focuses on treating relapsed or refractory lymphoma and leukemia using engineered NKT cells.

What is the stock symbol for Athenex?

The stock symbol for Athenex is ATNX.

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