Allogene Therapeutics, in Collaboration with Servier, Announces FDA Clearance of the IND for ALLO-501, an anti-CD19 Allogeneic CAR T (AlloCAR T™) Therapy
January 28, 2019 at 08:30 am EST
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Allogene Therapeutics, Inc. announced that the U.S. Food & Drug Administration (FDA) has cleared Allogene’s Investigational New Drug (IND) application for ALLO-501 in patients with relapsed/refractory non-Hodgkin lymphoma (NHL). Allogene is the sponsor of the ALLO-501 program. The Phase 1 portion of the study is designed to assess the safety and tolerability at increasing dose levels of ALLO-501 in the most common NHL subtypes of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). ALLO-501 will be administered following lymphodepletion with fludarabine/cyclophosphamide (Flu/Cy) and ALLO-647, Allogene’s proprietary anti-CD52 monoclonal antibody. The ALPHA Phase 1 trial will treat up to 24 patients and is on track for initiation in the first half of 2019. NHL is the most common hematological malignancy in the United States, with 74,680 new cases and 19,910 deaths estimated in 2018.1 B-cell lymphomas, such as DLBCL and FL, make up approximately 85% of NHL cases in the United States. DLBCL is the most common type of NHL in the United States, accounting for one out of every three cases. A retrospective analysis of patients with relapsed/refractory DLBCL, who were not treated with autologous CAR T therapy, found that outcomes in this population are poor, with a median overall survival of approximately six months and only seven percent attaining a complete response. UCART19 and ALLO-501 are being developed under a joint clinical development collaboration between Servier and Allogene, and are exclusively licensed from Cellectis. UCART19 and ALLO-501 utilize the TALEN® gene-editing technology pioneered and owned by Cellectis. Both ALLO-501 and UCART19 feature the same construct and editing but are manufactured using a different process. The UCART19 clinical program for the treatment of relapsed/refractory acute lymphoblastic leukemia (ALL) is sponsored by Servier. Allogene has exclusive rights to UCART19 and ALLO-501 in the U.S. while Servier retains exclusive rights for all other countries.
Allogene Therapeutics, Inc. is a clinical-stage immuno-oncology company. The Company is focused on development of genetically engineered allogeneic T cell product candidates for the treatment of cancer and autoimmune diseases. It is focused on four core programs: Large B-Cell Lymphoma (LBCL), Chronic Lymphocytic Leukemia (CLL), Autoimmune Disease and Renal Cell Carcinoma. It is developing a pipeline of multiple allogeneic chimeric antigen receptor (CAR) T cell product candidates utilizing protein engineering, gene editing, gene insertion and advanced proprietary T cell manufacturing technologies. Its product candidate, cemacabtagene ansegedleucel, referred to as cema-cel, is an engineered allogeneic CAR T cell product candidate that targets CD19, a protein expressed on the cell surface of B cells and a validated target for B cell driven hematological malignancies. It is focused on developing cema-cel for LBCL and CLL. Its pipeline also includes ALLO-316, ALLO-329 and ALLO-647.
Allogene Therapeutics, in Collaboration with Servier, Announces FDA Clearance of the IND for ALLO-501, an anti-CD19 Allogeneic CAR T (AlloCAR T™) Therapy
ALLOGENE THERAPEUTICS, INC. 
