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Cellectis Gets Investigational New Drug Approval From FDA For Phase 1 Trials With UCART123

Posted by on February 6, 2017 5:34 PM
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Categories: Stocks

February 6, 2017: Cellectis announced that it has received an Investigational New Drug approval from the FDA to conduct Phase 1 clinical trials with UCART123, the Company’s most advanced, wholly owned TALEN gene-edited product candidate, in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN). This marks the first allogeneic, “off-the-shelf” gene-edited CAR T-cell product candidate that the FDA has approved for clinical trials.

Cellectis intends to initiate Phase 1 trials in the first half of 2017.

February 5, 2017: Cellectis is a high risk boom or bust play. I bought Cellectis stock last week in my personal trading account. Cellectis is a high-risk stock you should not invest more in than you are willing to lose.

Back in November of 2015, the DailyMail ran an incredible story about how baby Layla was born with leukemia. Baby Layla had undergone the traditional chemotherapy and bone marrow transplant procedures but the cancer returned. Doctor’s told baby Layla’s parents that nothing else could be done and that they needed to prepare themselves for her death.

A French biotech company called Cellectis gave her an experimental therapy called CAR-T and it saved baby Layla’s life. You can read the incredible story here: http://www.dailymail.co.uk/health/article-3305603/World-baby-girl-battling-leukaemia-saved-miracle-treatment-Genetically-modified-cells-hunt-kill-disease-transform-cancer-care.html

Cellectis is one of many companies advancing the exciting science of CAR-T therapy but Cellectis has, in some ways, a superior technology. Unlike other CAR-Ts in development, Cellectis’ cells have been reworked to act as “universal donor” cells.

In CAR-T therapies currently advancing through FDA medical trials, immune system cells need to be removed from a patient’s blood. These immune cells are then worked on in a lab where the genes are edited and then the cells are multiplied. Finally, these cells are reinfused back into the patient. As you can imagine, this is a very expensive process that costs tens of thousands of dollars and it only works for that one specific patient.

Cellectis’ CAR-T therapy is different in that they have created a line of CAR-T cells that can work in anyone. This means that it can be mass produced and sold at a much lower cost than other CAR-T cell therapies.

Another Baby Girl Save In December 2015

A second child, who was treated in December 2015 when she was 16 months old, was also saved and is currently healthy.

The process that saved the babies is not perfect as Michael Le Page writes…

In addition to CAR-T therapy, Cellectis used CRISPR because the gene, called TCRαβ, was not disabled in 0.7% of the cells injected into the children, and both girls developed signs of graft-versus-host disease. But the team was on the lookout for this and treated it as soon as signs emerged.

Once the girls’ immune systems were restored, the gene-edited cells were themselves seen as foreign and killed off.

January 25, 2017: Cellectis stock up on circulation of Science Translational Medicine publication Report titled “Molecular remission of infant B-ALL after infusion of universal TALEN gene-edited CAR T cells”. Source: http://stm.sciencemag.org/content/9/374/eaaj2013

Cellectis Stock Chart

Cellectis is a biopharmaceutical company focused on developing immunotherapies based on gene-edited engineered CAR T-cells (UCART). The company’s mission is to develop a new generation of cancer therapies based on engineered T-cells. Cellectis capitalizes on its 17 years of expertise in genome engineering – based on its flagship TALEN® products and meganucleases and pioneering electroporation PulseAgile technology – to create a new generation of immunotherapies. CAR technologies are designed to target surface antigens expressed on cells. Using its life science-focused, pioneering genome engineering technologies, Cellectis’ goal is to create innovative products in multiple fields and with various target markets.

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