• Agreement covers manu­fac­tur­ing of clin­i­cal supply for Cellectis’ UCART pipe­line
• Manufacturing to take place at Lonza’s GMP site in Geleen, Netherlands

{{image}}Basel, Switzerland and New York, NY (Press Release) – Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS – Nasdaq: CLLS), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on allo­geneic gene-edited CAR T-cells (UCART), and Lonza (SWX: LONN), an­nounced to­day that the com­pa­nies have entered into a manu­fac­tur­ing service agree­ment covering clin­i­cal manu­fac­tur­ing of Cellectis’ allo­geneic UCART prod­uct can­di­dates targeting hema­to­logical malig­nan­cies. Lonza is in charge of implementing Cellectis’ manu­fac­tur­ing processes as per current Good Manufacturing Practices (cGMP) in a way that meets the highest quality and safety standards outlined by the FDA. The manu­fac­tur­ing will take place at Lonza's GMP facility in Geleen, Netherlands.

William Monteith, Executive Vice Pres­i­dent, Technical Operations, Cellectis:

“Working with Lonza, a world-class solu­tions provider with deep ex­peri­ence in the bio­tech and pharma industries in­creases our global capabilities and allows Cellectis to fur­ther strengthen its manu­fac­tur­ing ex­per­tise. This agree­ment not only bolsters our prod­uct supply for clin­i­cal trials, but it ensures that we are producing first-rate prod­uct can­di­dates so that we can poten­tially de­liver new hope to patients living with cer­tain blood cancers.”

Alberto Santagostino, Senior Vice Pres­i­dent, Head of Cell & Gene Technologies, Lonza:

“Early-stage innovators with great science, like Cellectis, can find an ideal part­ner in Lonza as we bring great value in tech­ni­cal devel­op­ment and manu­fac­tur­ing, industrializing processes and enabling the journey to com­mer­cial­iza­tion. We will draw on the ex­peri­ence at our cell and gene ther­apy center of excellence in the Netherlands, ideally equipped to sup­port Cellectis in bringing their promising pipe­line of allo­geneic CAR-T ther­a­pies to people around the world in need of life-saving prod­ucts.”

Lonza's supply will com­ple­ment Cellectis' on­go­ing col­lab­o­ration and in-house manu­fac­tur­ing sites, IMPACT and SMART, which are cur­rently under con­struc­tion.

The manu­fac­tur­ing process of Cellectis’ allo­geneic CAR T-cell prod­uct line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, non-alloreactive engi­neered CAR T-cells. UCARTs are in­tended to be readily avail­able CAR T-cells for a large patient pop­u­la­tion. Their pro­duc­tion is industrialized with defined pharma­ceu­tical release criteria.

About Lonza

Lonza is an integrated solu­tions provider that creates value along the Healthcare Continuum®. Through our Pharma Biotech & Nutrition segment and our Specialty Ingredients segment businesses, we har­ness science and tech­nology to serve mar­kets along this con­tin­uum. We focus on creating a healthy en­viron­ment, promoting a healthier lifestyle and preventing illness through consumers' preventive health­care, as well as im­prov­ing patient health­care by sup­porting our customers to de­liver inno­va­tive med­i­cines that help treat or even cure severe dis­eases.

Patients and consumers benefit from our ability to transfer our pharma know-how to the health­care, hygiene and fast-moving consumer goods en­viron­ment and to the preservation and pro­tec­tion of the world where we live.

Founded in 1897 in the Swiss Alps, Lonza to­day is a well-respected global com­pany with more than 100 sites and offices and approx­i­mately 15,500 full-time employees world­wide at the end of 2018. The com­pany gen­er­ated sales of CHF 5.5 billion in 2018 with a CORE EBITDA of CHF 1.5 billion. Fur­ther in­for­ma­tion can be found at www.lonza.com.

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 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.

Additional In­for­ma­tion and Disclaimer

Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Ex­change. It has a sec­ond­ary listing on the Singapore Ex­change Se­cu­ri­ties Trading Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing re­quire­ments but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.

Certain matters discussed in this news release may con­sti­tute for­ward-looking state­ments. These state­ments are based on current ex­pec­ta­tions and esti­mates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these ex­pec­ta­tions and esti­mates will be achieved. Investors are cautioned that all for­ward-looking state­ments in­volve risks and un­cer­tainty and are qualified in their entirety. The actual results may differ ma­teri­ally in the future from the for­ward-looking state­ments in­cluded in this news release due to var­i­ous factors. Fur­ther­more, except as other­wise re­quired by law, Lonza Group Ltd disclaims any intention or obli­ga­tion to up­date the state­ments con­tained in this news release.

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.