Cellectis announces first administration of UCART123 in man within the framework of its study …

UCART123 is the first product candidate allogeneic “off-the-shelf” from the edition of genes to be tested in the United States

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New York, June 27, 2017 – Cellectis (Alternext : ALCLS ; Nasdaq : CLLS), a biopharmaceutical company focused on clinical stage, specialized in the development of immunotherapies based on cells CAR-T ingénierées (UCART), announces that the first patient has been treated in the framework of a clinical study of Phase I aimed to test the candidate product UCART123 in acute leukemia myeloblastique (LAM). UCART123 is a product candidate controlled by Cellectis, ingénieré thanks to the technology of editing of the genome, TALEN®. This is the first time that a product candidate based on cells CAR-T and allogeneic targeting CD123 will be evaluated in a clinical study.

This clinical study on the LAM is led by Dr. Gail J. Roboz, principal Investigator, Director of clinical programs and translationnels on the leukemia and Professor of medicine at Weill Cornell Medicine, and NewYork-Presbyterian Hospital.

The clinical trial will assess the safety and efficacy of UCART123 in patients with LAM. The LAM is a neoplasm devastating hematopoietic stem cell clones, characterized by the uncontrolled proliferation of immature cells tumor accumulating in the bone marrow, blood, and sometimes in other tissues. These cells disrupt the normal hematopoiesis and induce quickly a bone marrow failure. In the United States, the number of new cases of AML per year is estimated to be 19 950, the number of deaths is estimated to be 10 430 per year. If the complete response rate may reach 80 % among the youngest patients who have received cytotoxic chemotherapy, the majority of patients with AML relapse and die from this disease. Patients with AML who are carriers of genetic characteristics in high-risk belong to the category of patients with an urgent health need unmet, to the extent that the results obtained with existing therapies, including allogeneic stem cell transplant, are particularly bad.

“After having received in a short period of time the authorization of the regulatory authorities and ethics committees to initiate clinical studies for UCART123, the recruitment and treatment of our first patient represents a major step for Cellectis, and we are eager to recruit a first patient for our second Phase I study to UCART123 targeting leukemia with plasmacytoid dendritic cells (LpDC),” said the Doctor Loan Hoang-Sayag, medical Director of Cellectis. “This first program targeting CD123, will represent a paradigm shift for our society, to the extent that it will provide a lot of information and additional data to be very useful to control our platform-cells CAR-T ingénierées allogeneic. ”

“We are delighted with the recruitment of our first patient in the study UCART123 and we hope that this new immunotherapy will prove to be a weapon in a significant and effective against AML,” said Dr. Roboz.

This clinical trial is part of a strategic alliance for translational research, formed between Cellectis and Weill Cornell Medicine in 2015. Dr. Monica Guzman, a Professor of pharmacology in medicine at Weill Cornell Medicine, is coinvestigatrice. His work focuses on the preclinical studies and tests in the initial phase to optimize the development of drugs targeting the stem cells against the cancer.

About Cellectis
Cellectis is a biopharmaceutical company in clinical stage specialized in the development of a new generation of cancer immunotherapies based on cells CAR-T ingénierées (UCART). Capitalizing on her 17 years of expertise in genome engineering, its technology editing of the genome, TALEN® and the pioneering technology of electroporation PulseAgile – Cellectis uses the power of the immune system to target and eliminate cancer cells.

Thanks to its technology frontier of genome engineering applied to life sciences, the Cellectis aims to create innovative products in multiple areas and targeting multiple markets.

Cellectis is listed on the Alternext market (code : ALCLS), as well as on the Nasdaq (code : CLLS). For more information, please visit our website : www.cellectis.com

Talking about gene editing? We do it.
TALEN® is a registered trademark, property of Cellectis

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