Cellectis’ UCART19 Receives Advanced-Therapy Medicinal Product Classification from EMA

Regulatory News :

Cellectis (Paris:ALCLS) (Alternext: ALCLS.PA), a leader of allogeneic CAR T-cell therapies, is pleased to announce it received a Scientific recommendation from the European Medicines Agency (EMA), in consultation with the European Commission, for UCART19, its lead product candidate in adoptive immunotherapy against CD19 expressing leukemias and lymphomas.

UCART19 fulfills the definition of an Advanced-Therapy medicinal Product (ATmP) being eligible for Scientific Advices and Assessment from the EMA Committee for Advanced Therapies (CAT) as well as for European centralized Marketing Authorization Approval.

The EMA/CAT considers that Cellectis’ allogeneic engineered Chimeric Antigen Receptor (CAR+) T-cells fall within the definition of a Gene Therapy Medicinal Product.

Furthermore, Cellectis qualifies for the incentives available to Small and Medium size Enterprises (SME) developing ATmP.

About Cellectis
Cellectis is a biopharmaceutical company focused on oncology. The company’s mission is to develop a novel generation of therapy based on engineered T-cells to treat cancer. Cellectis capitalizes on its 14 years of expertise in genome engineering, based on TALEN™, meganucleases and the state-of-the-art electroporation technology Pulse Agile, to create a new generation of cancer immunotherapy for treating leukemias and solid tumors. Cellectis adoptive cancer immunotherapy for chronic and acute leukemias is based on the first allogeneic T-cell chimeric antigen receptor (CAR) technology. CAR technologies are designed to target surface antigens expressed on cells. These treatments reduce toxicities associated with current chemotherapeutics and have the potential for curative therapy. The Cellectis Group is focused on life sciences and uses leading genome engineering technologies to build innovative products in various fields and markets. Cellectis is listed on the NYSE Alternext market (ticker: ALCLS). To find out more about us, visit our website: www.cellectis.com.

Disclaimer
This press release and the information contained herein do not constitute an offer to sell or subscribe, or a solicitation of an offer to buy or subscribe for shares in Cellectis in any country. This press release contains forward-looking statements that relate to the Company’s objectives based on the current expectations and assumptions of the Company’s management only and involve unforeseeable risk and uncertainties that could cause the Company to fail to achieve the objectives expressed by the forward-looking statements.