New York, NY (Press Release) – Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing im­mu­no­ther­apies based on gene-edited allo­geneic CAR T-cells (UCART), to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has lifted the clin­i­cal hold on the Phase 1 MELANI-01 trial eval­u­ating the UCARTCS1 prod­uct can­di­date for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple myeloma (MM).

Cellectis worked closely with the FDA over the past months, to address the agency’s re­quests, which in­clude ad­just­ments to the MELANI-01 clin­i­cal protocol de­signed to en­hance patient safety.

Cellectis con­tinues to work with the clin­i­cal site staff and in­ves­ti­ga­tors to ef­fi­ciently ob­tain the re­quired local ap­prov­als to reopen the trial and resume patient en­roll­ment.

“We re­main confident in the po­ten­tial clin­i­cal ben­e­fit of UCARTCS1 prod­uct can­di­date for patients with re­lapsed / re­frac­tory mul­ti­ple myeloma, a widely unmet med­i­cal need that Cellectis will con­tinue to address. The safety of patients en­rolled in our clin­i­cal trials re­mains our priority, and we are com­mit­ted to resuming the clin­i­cal de­vel­op­ment of this promising pro­gram,” said Carrie Brownstein, MD, Chief Medical Of­fi­cer, Cellectis.

Patient en­roll­ment is on­go­ing in Cellectis’ two other pro­pri­e­tary Phase 1 dose escalation trials: AMELI-01 eval­u­ating UCART123 in re­lapsed and re­frac­tory acute myeloid leukemia and BALLI-01 eval­u­ating UCART22 in re­lapsed and re­frac­tory B-cell acute lymphoblastic leukemia.

About MELANI-01

MELANI-01 is a Phase 1 open-label First-In-Human dose escalation clin­i­cal study eval­u­ating UCARTCS1 prod­uct can­di­date for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple myeloma (MM). UCARTCS1 is an allo­geneic, off-the-shelf, gene-edited T-cell prod­uct can­di­date de­signed for the treat­ment of CS1 / SLAMF7-expressing hema­to­logic malig­nan­cies. CS1 (SLAMF7) is highly ex­pressed on MM tumor cells.

Learn more about the on­go­ing clin­i­cal trials at www.clinicaltrials.gov

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 32,270 new cases of MM will be diag­nosed, and 12,830 deaths are ex­pected to oc­cur in 2020 in the U.S. alone.

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 20 years of ex­per­tise in gene edit­ing, Cellectis is devel­op­ing life-changing prod­uct can­di­dates uti­liz­ing 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 (AML), B-cell acute lymphoblastic leukemia (B-ALL) and mul­ti­ple myeloma (MM).

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 within the meaning of appli­cable se­cu­ri­ties laws, in­clud­ing the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995. Forward-looking state­ments may be identified by words such as “could”, “estimate”, “expect”, “intend”, “is de­signed to”, “may”, “might”, “potential”, “promising”, “remain confident”, “should” and “will,” or the neg­a­tive of these and similar ex­pres­sions. These for­ward-looking state­ments, which are based on our man­age­ment’s cur­rent ex­pec­ta­tions and assump­tions and on in­for­ma­tion cur­rently avail­able to man­age­ment, in­clude state­ments about the timing and progress of clin­i­cal trials (including with respect o patient en­rol­ment and follow-up), and the timing of our pre­sen­ta­tion of data. These for­ward-looking state­ments are made in light of in­for­ma­tion cur­rently avail­able to us and are sub­ject to nu­mer­ous risks and un­cer­tainties, in­clud­ing with respect to the duration and se­ver­i­ty of the COVID-19 pan­dem­ic and gov­ern­mental and regu­la­tory measures implemented in re­sponse to the evolving situation. Fur­ther­more, many other im­por­tant factors, in­clud­ing those factors de­scribed in our Annual Report on Form 20-F and the fi­nan­cial re­port (including the man­age­ment re­port) for the year ended De­cem­ber 31, 2019 and sub­se­quent filings Cellectis makes with the Se­cu­ri­ties Ex­change Com­mis­sion from time to time, as well as other known and un­known risks and un­cer­tainties may ad­versely affect such for­ward-looking state­ments and cause our actual re­sults, per­for­mance or achieve­ments to be ma­teri­ally dif­fer­en­t from those ex­pressed or im­plied by the for­ward-looking state­ments. 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.