On October 18, 2021 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 reported that the U.S. Patent and Trademark Office has allowed patent claims around its NKT cellular immunotherapy platform (Press release, Athenex, OCT 18, 2021, View Source [SID1234591446]). While similar claims had already been granted in the European Union, these claims are the first allowed on this technology in the U.S.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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.