Cellectis Receives IND clearance for UCART20x22, its First in-house Manufactured Product Candidate for the Treatment of B-cell Malignancies

· UCART20x22 is Cellectis’ first allogeneic dual CAR T, targeting CD20 and CD22 simultaneously

· UCART20x22 is Cellectis’ first product candidate fully designed, developed and manufactured in-house

· Phase 1/2a clinical trial NatHaLi-01 expected to begin in second half of the year

August 1st, 2022 - New York, NY – Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared Cellectis’ Investigational New Drug (IND) application to initiate a Phase 1/2a clinical trial of UCART20x22 for patients with relapsed or refractory Non-Hodgkin Lymphoma (r/r NHL). The Company plans to begin enrolling patients in the NatHaLi-01 study in the second half of the year.

“We are delighted that the FDA has cleared our IND application for UCART20x22”, said André Choulika, PhD, Chief Executive Officer of Cellectis. “This is a very exciting product candidate, for two reasons: UCART20x22 will be our first dual allogeneic CAR T product candidate to enter clinical development, and dual targeting of CD20 and CD22, both validated targets in B-cell malignancies, has the potential to enhance tumor cell killing and increases the breadth of antigen targeting. These advantages may increase the addressable patient population and represent a potential therapeutic alternative to CD19-directed therapies.

UCART20x22 is also our first product candidate with fully integrated in-house development, showcasing our transformation into an end-to-end cell and gene therapy company, from discovery, process development, and GMP manufacturing to clinical development. We are very excited to start the clinical trial for patients with relapsed or refractory Non-Hodgkin Lymphoma.”

UCART20x22 features TALEN®-mediated disruptions of the TRAC gene (that has been shown to reduce the risk of graft-versus-host disease) and of the CD52 gene (to allow using a CD52-directed monoclonal antibody in patients’ preconditioning regimen and enhancing CAR T engraftment, expansion and persistence).

The Dose Finding portion of the study will evaluate UCART20x22 in a broad range of mature B-cell Non-Hodgkin lymphomas (NHL) which accounts for approximately 4% of all cancers[1]. It is estimated that 81,560 new cases of NHL and 20,720 deaths related to the disease occurred in the US in 2021[2], and 122,979 new cases of NHL and 49,684 deaths related to NHL occurred in Europe in 2020[3].
 

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[1] https://seer.cancer.gov/statfacts/html/nhl.html

[2] Siegel et al 2021-- https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21654

[3] International Agency for Research on Cancer 2020