Cellectis’ UCARTCS1 MELANI-01 Trial Commenced at MD Anderson Cancer Center

New York, NY (Press Release) – Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS; Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on gene-edited off-the-shelf CAR T-cells (UCART), to­day an­nounced the Com­pany has dosed the first patient in its UCARTCS1 clin­i­cal trial, MELANI-01, the first allo­geneic off-the-shelf CAR-T prod­uct can­di­date the U.S. Food and Drug Admin­istra­tion (FDA) has cleared to enter into clin­i­cal devel­op­ment for re­lapsed / re­frac­tory mul­ti­ple myeloma (R/R MM). The UCARTCS1 clin­i­cal trial is a Phase 1 dose-escalation study to eval­u­ate the safety, ex­pan­sion, persistence and clin­i­cal ac­­tiv­ity of UCARTCS1 cells in R/R MM patients.

“This first patient dosing for our MELANI-01 clin­i­cal trial is an im­por­tant ad­vancement, as our team has worked tirelessly to de­vel­op and take the CS1 target from the lab to the clinic,” said Dr. André Choulika, Chairman and CEO, Cellectis. “In taking this next clin­i­cal step, we look for­ward to deepen­ing our under­stand­ing of UCARTCS1 as a poten­tial new treat­ment op­tion for re­lapsed / re­frac­tory mul­ti­ple myeloma patients in the future.”

The MELANI-01 clin­i­cal trial is cur­rently open at MD Anderson Cancer Center in Houston, Texas, under the supervision of Dr. Krina Patel, Prin­ci­pal In­ves­ti­ga­tor, Study Coordinating In­ves­ti­ga­tor, Assis­tant Pro­fessor, ­De­part­ment of Lymphoma/Myeloma, Division of Cancer Medicine at MD Anderson Cancer Center, as well as Hackensack Meridian in New Jersey under the supervision of Dr. David Siegel, Director of the Multiple Myeloma In­sti­tute at John Theurer Cancer Center (JTCC) at Hackensack Uni­ver­sity Medical Center. Another site is planned to open at Weill Cornell Medicine in New York under the leadership of Dr. Adriana Rossi, Asso­ci­ate Clinical Director, Myeloma Center and Assis­tant Pro­fessor of Medicine, Division of He­ma­tol­ogy and Medical Oncology.

About Multiple Myeloma (MM)

Multiple myeloma is a cancer that affects a type of white blood cells called plasma cells that are spe­cial­ized mature B cells, which secrete anti­bodies to combat in­fec­tions. Multiple myeloma is char­ac­ter­ized by the un­con­trolled pro­lif­er­a­tion of neoplastic plasma cells in the bone mar­row, where they over­crowd healthy blood cells. Although MM is a chronic dis­ease and an exact cause has not yet been identified, re­searchers have made sig­nif­i­cant progress over the years in managing the dis­ease through better under­stand­ing MM’s pathophysiology. The progress in finding a cure needs to be con­tinued as The American Cancer Society esti­mates that 32,110 new cases of MM will be diag­nosed, and 12,960 deaths are ex­pec­ted to oc­cur in 2019 in the U.S. alone.

About UCARTCS1

UCARTCS1 is an allo­geneic, off-the-shelf, gene-edited T-cell prod­uct can­di­date de­signed for the treat­ment of mul­ti­ple myeloma. CS1 (SLAMF7) is highly ex­pressed on MM tumor cells and is an attractive target. The lim­i­ta­tion so far has been the presence of the CS1 target on the surface of T-cells, which has hindered the access to CAR-Ts. For example, the in­tro­duc­tion of a CAR con­struct in T-cells induces cross T-cell reactivity and leads to destruction of the CS1+ T-cell pop­u­la­tion during manu­fac­tur­ing. Cellectis solved this issue by using TALEN® gene edit­ing to knock out the CS1 gene from T-cells before introducing the CS1 CAR con­struct.

About Cellectis

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 19 years of ex­per­tise in gene edit­ing, Cellectis is devel­op­ing life-changing prod­uct can­di­dates uti­liz­ing TALEN®, its pro­pri­e­tary 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 (AML), B-cell acute lymphoblastic leukemia (B-ALL), mul­ti­ple myeloma (MM), Hodgkin lym­phoma (HL) and non-Hodgkin lym­phoma (NHL).

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). For more in­for­ma­tion, visit www.cellectis.com.

Follow Cellectis on social media: @cellectis, LinkedIn and YouTube.

TALEN® is a registered trademark owned by Cellectis.

Disclaimer

This press re­lease con­tains “forward-looking” state­ments that are based on our man­agement’s cur­rent ex­pec­ta­tions and assump­tions and on in­for­ma­tion cur­rently avail­able to man­agement. Forward-looking state­ments in­volve­ known and unknown risks, un­cer­tainties and other factors that may cause our actual re­­sults, per­for­mance or achieve­ments to be ma­teri­ally dif­fer­en­t from any future re­­sults, per­for­mance or achieve­ments ex­pressed or im­plied by the for­ward-looking state­ments. Fur­ther in­for­ma­tion on the risk factors that may affect com­pany business and fi­nan­cial per­for­mance is in­cluded in Cellectis’ Annual Report on Form 20-F and the fi­nan­cial report (including the man­agement report) for the year ended De­cem­ber 31, 2018 and sub­se­quent filings Cellectis makes with the Se­cu­ri­ties Ex­change Com­mis­sion from time to time. Except as re­quired by law, we assume no obli­ga­tion to up­date these for­ward-looking state­ments pub­licly, or to up­date the reasons why actual re­­sults could differ ma­teri­ally from those antic­i­pated in the for­ward-looking state­ments, even if new in­for­ma­tion be­comes avail­able in the future.

Source: Cellectis.