21 January 2020 - - The first patient has been dosed in US-based clinical-stage biopharmaceutical company Cellectis' (PAR: ALCLS) (NASDAQ: CLLS) (Euronext Growth: ALCLS) (NASDAQ: CLLS) AMELI-01, the Phase 1 dose escalation clinical trial evaluating a new UCART123 product candidate in relapsed/refractory acute myeloid leukemia, the company said.

This trial, sponsored by Cellectis, is part of an Investigational New Drug from the US Food and Drug Administration for a new UCART123 construct and an optimised production process, and will evaluate the safety, expansion, persistence and clinical activity of the product candidate in patients with relapsed/refractory AML.

AMELI-01 replaces the first US clinical trial assessing the UCART123 product candidate.

This clinical trial is led by Gail J. Roboz, M.D., Professor of Medicine at Weill Cornell Medicine and New York-Presbyterian (New York, USA), in collaboration with Naveen Pemmaraju, M.D., Associate Professor, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center (Texas, USA), David Sallman, M.D., Assistant Member in the Malignant Hematology Department at H. Lee Moffitt Cancer Center (Florida, USA), and Daniel DeAngelo, M.D., Ph.D., Institute Physician and director of Clinical and Translational Research of Adult Leukemia at Dana Farber Cancer Institute (Massachusetts, USA).

Our wholly controlled product candidate, UCART123, is a gene-edited T-cell investigational drug that targets CD123, an antigen expressed at the surface of leukemic cells in AML.

In July 2019, the US Food and Drug Administration accepted an Investigational New Drug for Cellectis to conduct a Phase 1 clinical trial with an optimised version of the UCART123 product candidate in patients living with AML.

This IND includes a new UCART123 construct and an optimized production process, and replaces our previous IND on UCART123.

Cellectis is developing the first of its kind allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients.

As a clinical-stage biopharmaceutical company with over 20 years of expertise in gene editing, Cellectis is developing life-changing product candidates utilising TALEN, its gene editing technology, and PulseAgile, its pioneering electroporation system to harness the power of the immune system in order to target and eradicate cancer cells.

As part of its commitment to a cure, Cellectis remains dedicated to its goal of providing life-saving UCART product candidates to address unmet needs for multiple cancers including acute myeloid leukemia, B-cell acute lymphoblastic leukemia (B-ALL), multiple myeloma, Hodgkin lymphoma and non-Hodgkin lymphoma.

Cellectis headquarters are in Paris, France, with additional locations in New York, New York and Raleigh, North Carolina. Cellectis is listed on the NASDAQ Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS).