Athenex, Texas Children’s Cancer Center, and the Center for Cell and Gene Therapy at Baylor College of Medicine Present New Clinical Data on GD2 CAR-NKT Cells in Neuroblastoma at ASGCT Annual Meeting

  • Data presented by investigators from the Texas Children’s Cancer Center
  • One PR, one CR and four SDs out of 11 patients enrolled
  • GD2 CAR NKT cells were well tolerated with no dose limiting toxicities
  • CAR-NKT AUC normalized to disease burden (AUC/Curie score) was associated with response to therapy.

BUFFALO, N.Y., May 17, 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, led by its Orascovery platform, today announced that investigators from Texas Children’s Cancer Center and the Center for Cell and Gene Therapy at Baylor College of Medicine presented new clinical data from the ongoing GINAKIT2 phase 1 study of Athenex’s cell therapy candidate KUR-501 targeting GD2 in neuroblastoma at the American Society of Gene & Cell Therapy (ASGCT) 24th Annual Meeting on Friday, May 14, at 11 am ET.

Observed responses to date in 11 evaluable, heavily pretreated patients with neuroblastoma, include one complete response (CR) and one partial response (PR). Four additional patients have exhibited stable disease (SD). The durations of response for the CR and PR were approximately 5 and 3 months, respectively. No patients experienced grade 2 or higher toxicities related to the GD2-CAR NKTs. Post-treatment tumor biopsies showed GD2-CAR NKTs homing to metastatic lesions at all dose levels. The CAR-NKT AUC normalized to disease burden (AUC/Curie score using MIBG scan quantified tumor burden) appears to be associated with response to therapy.

“The results of the ongoing phase I study further validate the clinical activity of CAR-NKT cells,” said Dr. Kurt Gunter, Chief Medical Officer of Athenex Cell Therapy. “The data thus far demonstrate clinical responses and tumor homing with an attractive safety profile. We are grateful to the patients and families for their participation in these studies and to the scientists and physicians at Texas Children’s Cancer Center and Baylor College of Medicine for their scientific leadership.”

Dr. Andras Heczey, from Baylor College of Medicine, presented updated data from the GINAKIT2 study of autologous CAR-NKT cells. The title of the presentation is “Natural Killer T Cells Expressing a GD2-CAR and IL-15 Are Safe and Can Induce Complete Remission in Children with Relapsed Neuroblastoma - A First-in-Human, Phase 1 Trial”. Dr. Heczey is the principal investigator for this study. The abstract and his work were selected for presentation at this year’s Clinical Trials Spotlight Symposium.

“We are encouraged by the reassuring safety profile, expansion/persistence/tumor trafficking parameters and by the evidence of clinical activity with autologous, engineered CAR-NKT cell therapy at relatively low doses,” said Dr. Heczey, Associate Professor of Pediatrics – Oncology at Baylor College of Medicine and member of the Dan L Duncan Comprehensive Cancer Center. “We look forward to advancing the program into additional dose levels and treating additional patients.”

About KUR-501

KUR-501 is an autologous product in which NKT cells are engineered with a CAR targeting GD2, which is expressed on almost all neuroblastoma tumors, as well as other malignancies. KUR-501 is being tested in the phase 1 GINAKIT2 clinical study (NCT03294954) in patients with R/R high risk neuroblastoma. The single-arm study will evaluate six dose levels of KUR-501 with patients receiving pre-dose lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine.

Neuroblastoma is a pediatric cancer and patients with R/R high risk neuroblastoma have a poor prognosis and a significant unmet medical need. 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.

The GINAKIT2 study is supported by Athenex, Inc., which acquired Kuur Therapeutics in May 2021, and Alex’s Lemonade Stand Foundation, is conducted by Athenex’s collaborator, BCM, and is currently recruiting patients.

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) Cell therapy, which includes recently acquired Kuur Therapeutics, 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

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, uncertainties around regulatory reviews and approvals; 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 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 meet funding conditions under our 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 potential 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; 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:

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

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

Tim McCarthy
LifeSci Advisors, LLC
Email: tim@lifesciadvisors.com


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