- Allogeneic “off-the-shelf” chimeric antigen receptor-natural killer T cell (CAR-NKT) therapy platform could overcome many of the challenges of current autologous CAR-T therapies
- The CAR-NKT cell platform has tumor-homing properties and is unlikely to cause GvHD
- Phase 1 ANCHOR clinical study will enroll adult patients with relapsed/refractory (R/R) CD19 positive malignancies
HOUSTON–(BUSINESS WIRE)–Kuur Therapeutics, a leader in the development of off-the-shelf CAR-NKT cell immunotherapies for the treatment of hematological and solid malignancies, today announced the treatment of the first patients in its ANCHOR phase 1 study of KUR-502, an allogeneic CAR-NKT therapy.
“This is an important day, as the initiation and dosing of the first patients in the ANCHOR phase 1 clinical study marks the first time that patients have been treated with an allogeneic engineered CAR-NKT cell therapy,” said Dr. Carlos Ramos, Principal Investigator of the ANCHOR study, Professor of Medicine in the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine and member of the Dan L Duncan Comprehensive Cancer Center. “CAR-NKT cells have the potential to offer a distinct set of advantages over other lymphocytes commonly used for cell therapy, such as T cells. We are pleased to be advancing this ground-breaking first-in-human clinical study and anticipate that CAR-NKT cells could be an important treatment option for patients with both hematological and solid tumors in the future.”
“With the initiation of the ANCHOR study of KUR-502 in CD19 positive hematological malignancies, we are able to turn our focus to exploring the effects of off-the-shelf CAR-NKT cells.”
Kevin S. Boyle, Sr.,
Chief Executive Officer, Kuur Therapuetics
“This study will allow us to evaluate our platform technology with a validated target in CD19 and validated indications, generating critical data to advance our allogeneic efforts. Together with the results from our proof of concept GINAKIT2 study of KUR-501 in neuroblastoma, the forthcoming data from the ANCHOR study will guide future development of our next generation platform technology.”
KUR-502 is built on Kuur’s next-generation CAR-NKT platform, with novel engineering capabilities that harness and enhance the unique tumor-homing properties of NKT cells. This NKT platform technology was developed in the CAGT Lab of Dr. Leonid Metelitsa, Professor of Pediatrics-Oncology at Baylor College of Medicine and Texas Children’s Hospital and member of the Dan L Duncan Comprehensive Cancer Center, and KUR-502 was produced by the CAGT cGMP facility. One of the challenges with allogeneic therapies is that infusing a patient with donor-derived lymphocytes can induce graft versus host disease (GvHD), a potentially life-threatening condition in which the infused cells recognize the patient’s tissues as foreign. The NKT cells used in Kuur’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 Kuur’s collaborator, Baylor College of Medicine.
KUR-502 is an innovative allogeneic (off-the-shelf) product in which natural killer T cells are engineered with a chimeric antigen receptor targeting CD19. KUR-502 is engineered with a CD19-specific CAR construct that is additionally designed to secrete 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. In addition, the CAR-NKT cells express short hairpin RNA (shRNA) designed to downregulate HLA class I and class II expression, which may minimize rejection by the patient’s immune system and further enhance persistence. The CAR, IL-15 and shRNAs are effectively expressed in NKT cells via a single gammaretroviral vector, allowing for one-hit generation of off-the-shelf CAR-NKT cells. In contrast to off-the-shelf CAR therapy with conventional alpha-beta T cells, gene editing to remove the TCR to prevent GvHD is not required for off-the-shelf CAR-NKT therapy. KUR-502 is manufactured from healthy donors, from whom cell therapy products can be prepared in large quantities from a single procedure and used to treat many different patients.
Kuur Therapeutics is a clinical-stage biopharmaceutical company focused on the development of off-the-shelf CAR-NKT cell immunotherapies for the treatment of hematological and solid malignancies. The company’s revolutionary platform engineers CARs expressed by invariant NKT cells, a subset of T lymphocytes, and is being developed in partnership with Baylor College of Medicine and Texas Children’s Hospital. Allogeneic cell therapy has the potential to be much faster and less expensive than patient-specific autologous products, and NKT cells offer several advantages over other cell types for allogeneic immunotherapy applications. NKT cells have the cytotoxic and anti-tumor properties of conventional T cells, but with other biological attributes that are expected to improve their ability to attack hematological and solid tumors. These include innate tissue and solid tumor homing properties, as well as endogenous anti-tumor activity based on the ability to eliminate immune suppressive cells and activate host immune cells within the tumor microenvironment.
Kuur’s CAR-NKT platform is currently being explored in two phase 1 clinical studies, the proof of concept GINAKIT2 study of autologous therapy KUR-501, in patients with high risk, relapsed/refractory neuroblastoma, and the phase 1 ANCHOR study of allogeneic therapy KUR-502, in adult patients with relapsed/refractory CD19 positive malignancies.
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