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Athenex and the Center for Cell and Gene Therapy Announce Allowance of Our First U.S. Patent Claims Around CAR-NKT Cell Therapy

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Patent includes a pharmaceutical composition claim comprising a plurality of genetically modified CD62L-positive human NKT cells comprising at least one chimeric antigen receptor (CAR)

Patent protection helps validate the groundbreaking innovation of Dr. Leonid Metelitsa in harnessing NKT cell technologies for adoptive cell transfer therapy in oncology

BUFFALO, N.Y., Oct. 18, 2021 (GLOBE NEWSWIRE) -- Athenex (NASDAQ: ATNX), the leading developer of NKT cell therapy and the Center for Cell and Gene Therapy at Baylor College of Medicine, Texas Children’s Hospital and Houston Methodist Hospital today announced that the U.S. Patent and Trademark Office has allowed patent claims around its NKT cellular immunotherapy platform. While similar claims had already been granted in the European Union, these claims are the first allowed on this technology in the U.S.

“Va24-invariant natural killer T (NKT) cells are a specialized T cell population in the body that play a role in many types of immune responses,” said Leonid Metelitsa, M.D., Ph.D., Professor and Director, Center for Advanced Innate Cell Therapy, Texas Children's Cancer and Hematology Center, Department of Pediatrics, Baylor College of Medicine. “We discovered that under certain conditions, NKT cells acquire CD62L, which is a marker of central memory T cells (G. Tian et al., J Clin Invest, 2016). When we redirected these cells with a tumor-specific CAR, we found that CD62L-positive NKT cells mediated durable antitumor responses in pre-clinical tumor models, while CD62L-negative cells did not. This discovery led to the development of cell therapy products that are currently in early phase clinical testing.”

Dan Lang, M.D., President, Athenex Cell Therapy, Vice President, Corporate Development/Communication commented, “We are very pleased to have received allowance of claims on one of our foundational patent families on NKT cells. These claims are important for our platform technology because we believe CD62L+ NKT cells have a high rate of in vitro expansion, enhanced in vivo persistence, and potent anti-tumor activity. We look forward to further studying these important attributes in our KUR-501 and KUR-502 clinical development programs, both of which use this technology. We have over 100 patent applications pending and issued around the world, and we believe this first U.S. patent allowance firmly establishes Athenex as one of the leaders in NKT cell therapy.”

About KUR-501
KUR-501 is an autologous product in which natural killer T (NKT) cells are engineered with a chimeric antigen receptor (CAR) targeting GD2, which is expressed on almost all neuroblastoma tumors. KUR-501 is also designed to address key limitations of current CAR immune cell therapies by secreting the cytokine IL-15, which has been shown in nonclinical studies to increase the persistence of CAR-NKT cells and improve their efficacy within the immunosuppressive tumor microenvironment. KUR-501 is being tested in a phase 1 GINAKIT2 clinical study (NCT03294954) in patients with R/R high-risk neuroblastoma at Texas Children’s Hospital by Andras Heczey, M.D., Associate Professor of Pediatrics-Oncology at Baylor College of Medicine. The KUR-501 development program is also designed to provide autologous proof-of-concept for CAR-NKT cells in solid tumors using a validated target and has extensive potential applications in the treatment of hematological and solid tumors.

About KUR-502
KUR-502 is built on Athenex’s next-generation CAR-NKT platform with novel engineering capabilities that harness and enhance the unique tumor-homing properties of NKT cells. The NKT cells used in Athenex’s CAR-NKT platform have an invariant T cell receptor that does not distinguish between self- and non-self tissues, making the cells unlikely to induce GvHD when given to another person. Preclinical data generated by Baylor College of Medicine indicate that while human CAR-T cells cause severe GvHD, CAR-NKT cells from the same donor do not.

The ANCHOR (NCT03774654) study is a phase 1, first-in-human, dose escalation evaluation of KUR-502 in adults with R/R CD19 positive malignancies including B cell lymphomas, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL). The single-arm study will evaluate three dose levels with patients receiving lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine followed by infusion with KUR-502.

Patients with R/R CD19 positive malignancies have limited effective treatment options. While CD19-directed autologous CAR-T cells are now available for these patients, they are limited by delays to get treatment, a requirement for patient leukapheresis, and issues with inferior quality leukapheresis starting material due to prior treatment. Off-the-shelf KUR-502 is designed to overcome these limitations.

The ANCHOR study is being sponsored and conducted by Athenex’s collaborator, the Center for Cell and Gene Therapy (CAGT) at Baylor with Carlos Ramos, M.D., Professor in the CAGT, serving as Principal Investigator and is currently recruiting participants at Houston Methodist Hospital.

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.

About Baylor College of Medicine
Baylor College of Medicine in Houston is recognized as a premier health sciences university and is known for excellence in education, research, and patient care. It is the only private medical school in the greater southwest and is ranked 22nd among medical schools for research and 17th for primary care by U.S. News & World Report. Baylor is listed 20th among all U.S. medical schools for National Institutes of Health funding and No. 1 in Texas. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Luke’s Medical Center, part of CHI St. Luke’s Health. Currently, Baylor has more than 3,000 trainees in medical, graduate, nurse anesthesia, physician assistant, orthotics, and genetic counselling, as well as residents and postdoctoral fellows. Follow Baylor College of Medicine on Facebook and Twitter

About Texas Children’s Hospital

Texas Children’s Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children’s hospital in Texas, and among the top in the nation, Texas Children’s has garnered widespread recognition for its expertise and breakthroughs in pediatric and women’s health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for pediatric research; Texas Children’s Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children’s Hospital West Campus, a community hospital in suburban West Houston; and Texas Children’s Hospital The Woodlands, the first hospital devoted to children’s care for communities north of Houston. The organization also created Texas Children’s Health Plan, the nation’s first HMO for children; Texas Children’s Pediatrics, the largest pediatric primary care network in the country; Texas Children’s Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that’s channeling care to children and women all over the world. Texas Children’s Hospital is affiliated with Baylor College of Medicine. For more information, go to www.texaschildrens.org. Get the latest news by visiting the online newsroom and Twitter at twitter.com/texaschildrens.

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; 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


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