GYA01 / Gyala Therap - LARVOL DELTA

CART Cell Therapy Targeting CD84 Alone or in Combination with CD19 for the Treatment of B-Cell Malignancies (ASH 2024) - "Moreover, it has been reported that patients with lower pre-therapy median CD19 density had increased risk of relapse after axicabtagene ciloleucel. In summary, CART84 cells demonstrated cytotoxicity towards B-ALL and aggressive B-cell lymphoma, both in vitro and in vivo, highlighting their potential as a therapeutic option for relapsed CD19negative B-cell malignancies. Furthermore, the "IF-BETTER" CD19/CD84-targeted dual CART cells, enhanced with their co-receptor, offer a promising approach for addressing CD19low B-ALL and B-cell lymphomas, while maintaining the safety profile of CD19-directed CART cell therapy."

CAR T-Cell Therapy • Combination therapy • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Burkitt Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • TFRC

Gyala Therapeutics unveils first-in-class CAR-T therapy targeting CD84 showing strong preclinical efficacy in hard-to-treat leukemias (PRNewswire) - "Strong and specific cytotoxicity against AML, T-ALL, and aggressive B-cell lymphoma cell lines, as well as primary patient samples. Significant efficacy in animal models, eradicating disease and prolonging survival."

Preclinical • Acute Myelogenous Leukemia • T Acute Lymphoblastic Leukemia

Gyala secures €3 million financing from Invivo Partners, Nara Capital and CDTI Innvierte to launch a Phase I trial in AML patients in H2 2025 (PRNewswire)

Financing • New P1 trial • Acute Myelogenous Leukemia • T Acute Lymphoblastic Leukemia

A novel chimeric antigen receptor T-cell therapy targeting CD84 for the treatment of acute myeloid and T-cell lymphoblastic leukemias. (PubMed, Leukemia) - "Furthermore, CART84 eliminated primary leukemic blasts while exhibiting low cytotoxicity against CD34+ HSPC in vitro and in humanized mouse models in vivo, suggesting a low risk of myelotoxicity. These results support CD84 as a promising target for AML and T-ALL and provide the foundation for our upcoming first-in-human phase I/II clinical trial using CD84-directed CAR T cell therapy for patients with R/R AML and T-ALL (EudraCT 2024-519966-31-00)."

Journal • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CD34

HARNESSING CMV-VSTS FOR ALLOGENEIC CART84 THERAPY TO TARGET AML (EHA 2025) - "To better preserve CMV specificity in thawed CMV-VSTs, we tested OKT-3 as an activation method prior to transduction, which successfully maintained CMV specificity but resulted in low CAR84 expression.Additionally, we evaluated ARI-0001, an academic CD19-targeting CAR, as a control. Given the limited CAR84 expression in CMV-VSTs, efforts continue to optimize CAR84 expression while maintaining CMV specificity. This study highlights CMV-VSTs as a potential allogeneic CART platform and underscores the need for further refinement of transduction protocols to enhance therapeutic efficacy."

IO biomarker • Acute Myelogenous Leukemia • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Oncology • CD28 • CD4 • CD8

CAR T-CELL THERAPY TARGETING CD84 ALONE OR IN COMBINATION WITH CD19 FOR THE TREATMENT OF B-CELL MALIGNANCIES (EHA 2024) - "CART84 cells are highly cytotoxic towards aggressive B-cell lymphoma both in vitro and in vivo. CART84showed specific proliferation and cytokine secretion when co-cultured with CD84+ tumour cells. Furthermore, CD19/CD84-directed dual CAR T cells successfully expanded and displayed cytotoxicity againstCD19+/CD84+ NALM-6 cells in vitro, but not towards CD19-/CD84+ MOLM-13 cells."

CAR T-Cell Therapy • Combination therapy • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19