Two CAR-T cell therapies, AT-19 and XYF-19, are under development by Shanghai YaKe Biotechnology and Xi'An Yufan Biotechnology, respectively, targeting various B-cell lymphomas. These therapies leverage engineered autologous T-cells to target CD19, a protein expressed on the surface of lymphoma cells, offering potential new treatment options for patients with relapsed or refractory disease.
AT-19: Targeting Follicular Lymphoma and Other B-Cell Malignancies
AT-19, developed by Shanghai YaKe Biotechnology, is a gene therapy currently in development for relapsed or refractory B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin's lymphomas. This includes diffuse large B-cell lymphoma, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), high-grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), and follicular lymphoma. The therapy involves intravenous administration of autologous T cells expressing CD19 chimeric antigen receptors, designed to specifically target and eliminate CD19-expressing cancer cells. AT-19 was also previously in development for minimal residual disease (MRD) in B-cell malignancies.
XYF-19: Broad Application Across B-Cell Hematological Malignancies
XYF-19, developed by Xi'An Yufan Biotechnology, is being investigated for the treatment of relapsed/refractory B-cell hematological malignancies. This includes B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), follicular lymphoma, marginal zone B-cell lymphoma, Waldenstrom macroglobulinemia, hairy cell leukemia, diffuse large B-cell lymphoma, Burkitt lymphoma, and mantle cell lymphoma. Similar to AT-19, XYF-19 is administered intravenously and comprises autologous T-cells genetically transduced with a lentiviral vector to express chimeric antigen receptors (CAR) targeting cells expressing CD19. Notably, the CAR-T cells in XYF-19 are electroporated with CRISPR guide RNA to disrupt the expression of endogenous HPK1.
CAR-T Therapy: A Promising Approach
Chimeric antigen receptor (CAR) T-cell therapy represents a significant advancement in cancer immunotherapy. This approach involves modifying a patient's own T cells to recognize and attack cancer cells. The T cells are collected from the patient, genetically engineered to express a CAR that binds to a specific antigen on the cancer cells (in this case, CD19), and then infused back into the patient. These modified T cells can then specifically target and kill cancer cells expressing the target antigen.
Likelihood of Approval
GlobalData's Likelihood of Approval analytics tool assesses and predicts the probability of a drug progressing to the next stage in clinical development (PTSR) and ultimately being approved (LoA). This analysis is based on a combination of machine learning and a proprietary algorithm that processes data points from various databases. These tools provide valuable insights into the potential success of AT-19 and XYF-19, helping to inform investment and development decisions.
