Athenex, Texas Children’s Cancer Center, and the Center for Cell and Gene Therapy at Baylor College of Medicine to Present Phase 1 Clinical Data for KUR-501, an autologous GD2 CAR-NKT Cell Therapy for Relapsed/Refractory High Risk Neuroblastoma at the ASG
- Data presented by investigators from the Texas Children’s Cancer Center’s
Center for Advanced Innate Cell Therapy andBaylor College of Medicine - Data demonstrate expansion of CAR-NKT cells post-transfer in all patients, and objective responses in patients with relapsed/refractory neuroblastoma
- Evidence of therapeutic efficacy with 25% (3/12) Overall Response Rate (ORR), 58% (4 stable disease, 2 partial responses, 1 complete response/12) Disease Control Rate (DCR), and 2 out of 3 responses at dose level 4 (1x108/m2)
- Durable Complete Response persisting 12 months
- Analysis found that responders correlate with CD62L+ NKT frequency in the pre-infusion products as well as CAR-NKT area under the curve (AUC) in the peripheral blood post-infusion
- Well tolerated with no dose limiting toxicity; no immune associated neurotoxicity syndrome (ICANS) at the first four dose levels and one case of grade 2 CRS
Details of the presentations are as follows:
Oral Presentation Details
Abstract 54: Anti-GD2 CAR NKT cells are safe and produce antitumor responses in patients with relapsed/refractory neuroblastoma
Date/Time:
Session: Gene and Cell Therapy Trials in Progress
Presenter: Dr. Andras Heczey,
Location:
“Observing evidence of a dose response is extremely encouraging, and we are excited to see two out of three responses at 100 million cells/m2,” said
About KUR-501
KUR-501, is an autologous NKT cell CAR product that targets GD2, a tumor-associated antigen that is expressed on almost all neuroblastomas as well as melanomas, some sarcomas, and a variety of other tumors. GINAKIT2, a phase 1 single arm clinical study (NCT03294954) of KUR-501, in patients with refractory or recurrent high-risk neuroblastoma will evaluate up to six dose levels of KUR-501 following lymphodepletion with cyclophosphamide and fludarabine.
Neuroblastoma, a pediatric cancer of the sympathetic nervous system, typically the adrenal gland, is associated with a poor prognosis in children with high-risk disease and is a significant unmet medical need. The KUR-501 development program will provide autologous proof-of-concept for CAR-NKT cells in solid tumors using a validated target.
The GINAKIT2 study is supported by
About Athenex, Inc.
Founded in 2003,
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 “believe,” “look forward to,” “potential,” 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: our history of operating losses and the substantial doubt about our ability to continue as a going concern; our strategic pivot to focus on our cell therapy platform and our plan to dispose of non-core assets; our ability to obtain financing to fund operations, successfully redirect our resources and reduce our operating expenses; our ability to refinance, extend or repay our substantial indebtedness owed to our senior secured lender; 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; the preclinical and clinical results for Athenex’s drug candidates, which may not support further development of such drug candidates; the Company’s 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 uncertainty of ongoing legal proceedings; 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; risks and uncertainties inherent in litigation, including purported stockholder class actions; the impact of the COVID-19 pandemic and other macroeconomic factors, like the war in
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Source: Athenex, Inc.