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Cellectis S.A. (symbol: CLLS) is a clinical-stage biopharmaceutical company that specializes in developing cutting-edge cancer immunotherapies using gene-edited T-cells, known as UCART. With over 18 years of experience in gene editing, Cellectis leverages its proprietary TALEN® technology and PulseAgile electroporation system to harness the power of the immune system to combat cancer.
Cellectis is dedicated to creating innovative products in the fields of immuno-oncology and beyond. Its portfolio includes allogeneic Chimeric Antigen Receptor T-cells (CAR-T) product candidates and gene-edited hematopoietic stem and progenitor cells (HSPC) for various therapeutic applications.
Recent achievements include advancements in gene correction and gene insertion technologies, presented at esteemed scientific conferences. For instance, the company has introduced a novel method for circularizing non-viral single-strand DNA templates, enhancing gene editing outcomes in HSPCs. Cellectis is also collaborating with renowned pharmaceutical companies like AstraZeneca, further expanding its pipeline of allogeneic CAR T-cell therapies.
Financially, Cellectis is listed on both the NASDAQ (ticker: CLLS) and the NYSE Alternext (ticker: ALCLS) markets. The company's ongoing projects and research efforts are supported by robust investment and partnership agreements, showcasing its commitment to improving health outcomes through innovative biotechnological solutions.
For more information, visit the company's website at www.cellectis.com.
Cellectis (NASDAQ: CLLS) has published an article in Molecular Therapy showcasing their innovative SMART DUAL CAR T-cell approach for treating solid tumors. Using TALEN® gene editing technology, Cellectis has developed allogeneic CAR T-cells that express:
1. A constitutive CAR targeting FAP+ cancer-associated fibroblasts (CAFs) in solid tumors
2. An inducible CAR, expressed only in the presence of FAP+ CAFs, targeting mesothelin
This strategy aims to overcome challenges in solid tumor treatment, including low T-cell infiltration, immunosuppressive microenvironment, and on-target off-tumor toxicity. In mice models, these SMART Dual CAR T-cells efficiently infiltrated and targeted triple-negative breast tumors without observable off-tumor toxicity.
Cellectis (NASDAQ: CLLS), a clinical-stage biotechnology company focused on gene-editing and cell therapies, has appointed Dr. Adrian Kilcoyne as its new Chief Medical Officer. Dr. Kilcoyne brings extensive experience in oncology and cell therapy from his previous roles at Celularity, Humanigen, AstraZeneca, and Celgene. His appointment is expected to strengthen Cellectis' clinical development efforts in advancing their pipeline of next-generation CAR T-cell therapies.
Dr. Kilcoyne's background includes a medical degree from Trinity College, Dublin, training in Gynecological Oncology and Public Health Medicine, and an MBA. He replaces Dr. Mark Frattini, who is departing to pursue other opportunities. The company's CEO, André Choulika, expressed confidence in Dr. Kilcoyne's ability to contribute to Cellectis' mission of providing transformative UCART therapies to patients with significant unmet medical needs.
Cellectis provided its financial results for Q2 2024, reporting a cash position of $273 million as of June 30, 2024, and a cash runway projection into 2026. Key highlights include:
Pipeline Updates: UCART22 received ODD from both the FDA and the European Commission for ALL treatment, and RPDD from the FDA. CLLS52 (alemtuzumab) also received ODD from the FDA for ALL treatment.
Financial Performance: Consolidated revenues and other income increased to $16 million for the six months ended June 30, 2024, compared to $5.6 million for the same period in 2023. Consolidated net loss reduced to $19.6 million from $41.8 million, reflecting better financial management and increased revenues.
Partnerships: Cellectis announced a $140 million investment from AstraZeneca, which now owns approximately 44% of Cellectis' share capital.
Research: A significant publication in Nature Communications on their non-viral gene therapy approach for SCD.
Cellectis (CLLS) has released its monthly share capital and voting rights information as of July 31, 2024, in compliance with French financial market regulations. The report indicates that the total number of shares in the capital is 100,093,635, while the total number of voting rights stands at 88,029,164. This information is important for investors to understand the company's ownership structure and potential voting power distribution.
The press release provides contact details for media and investor relations, including Pascalyne Wilson (Director of Communications) and Arthur Stril (Interim Chief Financial Officer). This transparency in reporting and accessibility to company representatives demonstrates Cellectis' commitment to maintaining open communication channels with stakeholders and complying with regulatory requirements.
Cellectis (NASDAQ: CLLS) announced that the FDA has granted Orphan Drug Designation (ODD) to CLLS52 (alemtuzumab), used in the lymphodepletion regimen for UCART22 in the BALLI-01 clinical trial for relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). The addition of alemtuzumab to the fludarabine and cyclophosphamide regimen has shown sustained lymphodepletion and higher UCART22 cell expansion, leading to greater clinical activity.
Cellectis invented the combination of CD52 knockout UCART cells with a lymphodepleting regimen containing an anti-CD52 antibody. The CD52 knockout aims to make UCART products resistant to alemtuzumab. ODD status may help expedite and reduce costs for development, approval, and commercialization of CLLS52 for ALL treatment.
Cellectis (NASDAQ: CLLS) announced that the FDA has granted Orphan Drug (ODD) and Rare Pediatric Disease Designation (RPDD) Status to its UCART22 product candidate for treating Acute Lymphoblastic Leukemia (ALL). ALL represents 10% of leukemia cases in the US, progressing rapidly and often fatal if untreated. The designations highlight UCART22's potential to address urgent needs in ALL treatment, especially for patients ineligible for stem cell transplantation or relapsing after other therapies.
UCART22, an allogeneic CAR T-cell therapy, is being evaluated in the BALLI-01 Phase 1/2 study. Recent data showed a 67% preliminary response rate at Dose Level 2 for UCART22-P2, manufactured by Cellectis. The company expects to provide updates on BALLI-01 by year-end 2024. These FDA designations may expedite development and reduce costs for UCART22.
On July 5, 2024, Cellectis provided an update on its share capital and voting rights as required by Article 223-16 of the French financial markets authority.
The company, listed on the Euronext Growth market under ISIN code FR0010425595, reported a total of 100,093,635 shares in its capital as of June 30, 2024.
The total number of voting rights for the same period was 88,029,364.
For any queries, media can contact Pascalyne Wilson, Director of Communications, or Patricia Sosa Navarro, Chief of Staff to the CEO. Investor relations are managed by Arthur Stril, Interim CFO, and Ashley R. Robinson from LifeSci Advisors.
Cellectis, a clinical-stage biotechnology company listed on Euronext Growth (ALCLS) and Nasdaq (CLLS), held its shareholders' general meeting on June 28, 2024, in Paris. Approximately 40% of shares were exercised during the meeting, resulting in the adoption of resolutions 1 through 28 and the rejection of resolution 29, aligning with management's recommendations. Detailed voting results and resolutions are accessible on Cellectis' official website.
Cellectis, a clinical-stage biotechnology company, has published a scientific article in Scientific Reports, revealing three key factors for efficient TALE base editing. This gene-editing technology, which does not create DNA breaks like CRISPR/Cas9, holds promise for treating genetic diseases by converting cytosine (C) to thymine (T). The study identifies spacer length, TALEB architecture, and surrounding base composition as critical elements for enhancing editing efficiency. This research deepens the understanding of TALE base editors, potentially expanding their therapeutic applications. The full article is available on the Scientific Reports website.
Cellectis announced a breakthrough in gene therapy for Sickle Cell Disease (SCD) using a non-viral approach published in Nature Communications. The therapy employs TALEN® technology for precise HBB gene correction in hematopoietic stem and progenitor cells (HSPCs). This method achieves over 50% expression of normal hemoglobin in treated cells, effectively correcting the sickle cell phenotype without adverse effects. The preclinical data shows promising therapeutic potential and efficient engraftment in animal models, indicating readiness for clinical application. This innovative approach offers hope for addressing SCD and other genetic diseases.
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