Allogene and Servier Partner to Advance Allogeneic CAR-T Therapies for Cancer

VCBeat (WeChat Official Account: vcbeat) has learned that Allogene Therapeutics, a biotechnology company founded by former executives of Kite Pharma, will launch the Phase I clinical trial of its CAR-T therapy in the first half of this year. The project has currently received authorization from the U.S. Food and Drug Administration (FDA).

Allogene, a clinical-stage biotechnology company founded by David Chang and Arie Belldegrun, co-founders of CAR-T manufacturer Kite Pharma, is dedicated to developing allogeneic chimeric antigen receptor T cell (allogeneic CAR-T) therapies for cancer.

Allogene, headquartered in South San Francisco, California, announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for the new clinical trial named the ALPHA study. Allogene will conduct this study in collaboration with the French pharmaceutical company Servier. The study will enroll 24 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma, who will receive treatment with the CAR-T cell therapy ALLO-501 and the CD52-targeting monoclonal antibody ALLO-647.

ALLO-501 targets CD19, an antigen widely expressed in B-cell non-Hodgkin lymphomas (such as DLBCL and FL). CAR-T therapy will be administered following a lymphodepletion regimen consisting of the chemotherapy agents fludarabine and cyclophosphamide, which are used to create space for CAR-T cell expansion. ALLO-647 is also part of the lymphodepletion regimen.

David Chang, CEO and Co-Founder of Allogene Therapeutics, stated, “The initiation of the ALPHA trial represents a significant milestone for the company, bringing us one step closer to the ‘on-demand’ manufacturing of CAR-T therapies and making treatment more accessible to patients at critical stages of their disease.”

Dr. Patrick Therasse, Head of Oncology Research and Development at Servier, stated: “The upcoming clinical studies under the ALPHA project will enable us to better explore the potential benefits of allogeneic CAR-T therapy for non-Hodgkin lymphoma.”

UCART19 is another CAR-T therapy under investigation by Allogene. It, along with ALLO-501, will be co-developed by Servier and Allogene under an exclusive license from Cellectis. Both UCART19 and ALLO-501 utilize the TALEN® gene-editing technology pioneered and owned by Cellectis. While they share the same construct and editing functionality, their manufacturing processes differ. The clinical program for UCART19 in the treatment of relapsed or refractory acute lymphoblastic leukemia (ALL) is sponsored by Servier. Allogene holds exclusive rights to UCART19 and ALLO-501 in the United States, while Servier holds exclusive rights in other countries.

Data presented at the 2018 American Society of Hematology (ASH) Annual Meeting showed that among 16 patients evaluable for efficacy, 14 achieved complete remission within 28 or 42 days after receiving UCART19 therapy.

Servier is an international pharmaceutical company managed by a non-profit foundation, with its headquarters in France. The Group reinvests 25% of its turnover into research and development, and allocates all of its profits to the research and development of new therapeutic solutions. Servier drives corporate growth by pursuing innovation in key therapeutic areas, including cardiovascular diseases, immuno-inflammatory and neuropsychiatric disorders, cancer, diabetes, and high-quality generic medicines.

(Compiled by: Liao Min)