Cellectis’ Innovation Days event highlighted New Product Development, New Genome Surgery Platform .HEAL, and Manufacturing Capabilities
June 14, 2021 at 16:30 PM EDT
• Four new product candidates under pre-clinical development announced; UCART20x22; the first allogeneic bi-specific CAR-T cell targeting B-cell malignancies, and three additional product candidates for solid tumors UCARTMESO (targeting Mesothelin), UCARTMUC1 (targeting Mucin 1), UCARTFAP (targeting Cancer Associated Fibroblasts)
• .HEAL, Cellectis’ proprietary genome surgery HSC platform announced; initiating the Company’s venture into new disease targets; Sickle Cell Anemia, Lysosomal storage disease (LSD) and Primary Immunodeficiencies
• Cellectis’ GMP manufacturing facilities showcase new capabilities including; building more independence from contract manufacturing organizations and gain an increased control over gene and cell therapy process and development
• Proprietary integrated gene editing suite with Cellectis’ electroporation device PulseAgile and GeneEngine™; expanding its electroporation capabilities
NEW YORK, June 14, 2021 (GLOBE NEWSWIRE) -- Cellectis S.A. (NASDAQ: CLLS – EURONEXT GROWTH: ALCLS) (the “Company”), a clinical-stage biotechnological company employing its core proprietary technologies to develop products based on gene-editing with a portfolio of allogeneic chimeric antigen receptor (CAR) T-cells in the field of immuno-oncology and gene-edited hematopoietic stem cells (“HSC”) in other therapeutic indications, featured the Cellectis Innovation Days, a company event held on May 24-28, virtually. Each episode, ranging from 16 to 48 minutes, provides an inside look into the Company’s current and new product candidate pipeline, and manufacturing and technologies.
To watch a replay of all Cellectis Innovation Days episodes, click here.
“For the past four years, in addition to the clinical development of UCART22, UCARTCS1 and UCART123, we have been pushing forward the development our new pre-clinical UCART product candidates, venturing for the first time into the solid tumor space. Additionally, we are thrilled to announce Cellectis’ .HEAL genome surgery HSC platform, a new arm of Cellectis which focuses on monogenic diseases, like Sickle Cell Anemia. Lastly, we revealed our new in-house GMP manufacturing facilities in France and the United States, and unveiled our ability to move our product candidates from the bench, to bedside, with best-in-class proprietary technologies and techniques. We look forward to disclosing the potential of our newly announced capabilities over the coming years, and presenting upcoming clinical & translational data at future conferences.” said Dr. André Choulika, CEO, Cellectis.
Cellectis shared overview of the Company’s proprietary and partnered product pipelines
To date, more than 120 patients have been administered allogeneic CAR T cells utilizing technology developed by Cellectis, both in Cellectis-sponsored clinical trials and those of our licensing partners Allogene and Servier.
UCARTCS1 in patients with relapsed/ refractory multiple myeloma (r/r MM)
UCART22 in patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r B-ALL)
UCART123 in patients with relapsed or refractory acute myeloid leukemia (r/r AML)
Cellectis outlines four new UCART preclinical programs, targeting solid tumors
UCART20x22 ; the first allogeneic dual CAR T-cell candidate product for B-cell malignancies
UCARTMESO for mesothelin-expressing solid tumors
UCARTMUC1 for Mucin 1-expressing epithelial cancers
UCARTFAPtargeting Cancer Associated Fibroblasts (CAFs) in the tumor microenvironment
Investment in GMP manufacturing facilities provides Cellectis with more independence and control over gene and cell therapy process and development and production
Cellectis’ proprietary integrated gene editing suite; expanding electroporation capabilities
Cellectis reveals .HEAL, a genome surgery platform for genetic diseases
.HEAL highlights lead product candidate TALGlobin01, an autologous ex vivo TALEN®-edited CD34+ HSC therapy for the treatment of SCD.
Lysosomal storage disorders (LSD)
Hyper IgE syndrome
Still in collaboration with Pr. Toni Cathomen (University of Freiburg, Germany), Cellectis has developed a strategy applicable in HSCs and T-cells, in which a wild type cDNA sequence containing exon 9 to 24 is inserted into an intronic sequence of the STAT3 gene to restore its functionality. STAT3 is a signal transduction molecule that governs the cytokine response to extracellular signals. Mutation of STAT3 leads to Hyper IgE Syndrome. The expression level of STAT3 needs to be tightly regulated as two isoforms, STAT3α and STAT3β, that play oncogenic and tumor-suppressing roles, respectively, need to be expressed in certain ratio. This makes traditional gene therapy approaches very challenging. By using TALEN® designed by Cellectis, 70% of gene insertion could be achieved in poc experiments. Importantly, the STAT3α : STAT3β isoform expression ratio was maintained, which is a key step to restore function of STAT3 in patients.
Cellectis is a gene editing company, developing first of its kind therapeutic products. Cellecties utilizes an 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, and a platform to make therapeutic gene editing in hematopeitic stem cells for various diseases. As a clinical-stage biopharmaceutical company with over 21 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 treat diseases with unmet medical needs.
As part of its commitment to a cure, Cellectis remains dedicated to its goal of providing life-saving UCART product candidates for multiple cancers including acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL) and multiple myeloma (MM). .HEAL is a new platform focusing on hematopeitic stem cells to treat blood disorders, immunodeficiencies and lysosomial storage diseases.
Cellectis headquarters are in Paris, France, with 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.
TALEN® is a registered trademark owned by Cellectis.
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This presentation 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 “ “believe,” “expect,” “plan,” “designed to,” “suggest”, “look forward,” “will,” “should,” “would” 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 our research and development projects and priorities, our pre-clinical project development efforts, the timing and progress of clinical trials (including with respect to patient enrollment and follow-up), the timing of our presentation of clinical data, the adequacy of our supply of clinical vials, the timing of completion of construction of our Raleigh, North Carolina manufacturing facility, and operational capabilities at our manufacturing facilities. 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 numerous risks associated with biopharmaceutical product candidate development as well as the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation. With respect to our cash runway, our operating plans, including product development plans, may change as a result of various factors, including factors currently unknown to us. Furthermore, many other important factors, including those described in our Annual Report on Form 20-F and the financial report (including the management report) for the year ended December 31, 2020 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.