Athenex Announces Exclusive License Agreement with National Cancer Institute to Utilize T Cell Receptors Targeting Mutated p53, KRAS, and EGFR for the Development of Autologous and Allogeneic Cell Therapies

Athenex plans to expand the allogeneic NKT cell R&D pipeline with these new licensed TCRs to target solid tumors

BUFFALO, N.Y., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Athenex (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 a licensing agreement with the National Cancer Institute (NCI), an institute of the National Institutes of Health (NIH), to expand the development of T cell receptor (TCR) based allogeneic natural killer T (NKT) cell and autologous T cell therapeutic products for the treatment of human cancers.

Under the terms of the agreement, Athenex is granted worldwide rights to the development, manufacturing, and commercialization of allogeneic NKT products engineered via viral and non-viral means, and autologous T cell therapy products engineered via retrovirus and lentivirus-mediated gene transfer, to express certain TCRs discovered in the laboratory of Dr. Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI. The licensed TCRs recognize unique antigens derived from ‘hotspot’ mutations in p53, KRAS, and EGFR genes shared among multiple patients and tumor types. Athenex plans to engineer the TCRs into its NKT cell platform to develop an allogeneic “off-the-shelf” approach for solid tumor treatment.

“We are very pleased to have entered this licensing agreement that covers these important T cell receptors. KRAS and p53 are the most commonly mutated genes in epithelial cancers, including lung and colorectal cancers ⁽¹⁾,” said Daniel Lang, M.D., President, Athenex Cell Therapy, Vice President, Corporate Development and Communication. “By expressing these TCRs in our NKT cell platform, we are able to potentially expand beyond hematologic malignancies into solid tumors, and therefore expand the market by over one hundred thousand patients in the U.S. annually. Licensing these clinically important TCRs builds on the foundation we started by acquiring Kuur Therapeutics, and we believe further advances our objectives to be one of the leaders in cell therapy.”

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 technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) Cell therapy, 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. 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.

References

(1)	Hartmaier, R., Albacker, L., Chmielecki, J., Bailey, M., He, J., Goldberg, M., Ramkissoon, S., Suh, J., Elvin, J., Chiacchia, S., Frampton, G., Ross, J., Miller, V., Stephens, P., Lipson, D. (2017). High-Throughput Genomic Profiling of Adult Solid Tumors Reveals Novel Insights into Cancer Pathogenesis. Cancer Res, 77(9) 2464-2475. https://cancerres.aacrjournals.org/content/77/9/2464

Athenex Contacts

Investors

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

Caileigh Dougherty
Athenex, Inc.
Email: cdougherty@athenex.com