April 13, 2018 Source: biospace 89
During the J.P. Morgan Healthcare Conference Andre Choulika, chief executive officer of France-based Cellectis told BioSpace he was excited about the future of CAR-T therapies and where his company fits into the space.
Today the company has found some sure financial footing that will support its efforts through the remainder of the year. The company secured $163.7 million in an initial public offering. The funding will be used to continue the development of Cellectis’ off-the-shelf CAR-T products and drive them toward regulatory approval.
In a filing with the U.S. Securities and Exchange Commission Cellectis outlined the plans it has for the funds raised in the IPO. The majority of the funds, about $100 million, will be used to establish commercial capabilities, which includes the construction of a proprietary state-of-the-art gene-edited cell manufacturing plant for its UCART products. Cellectis said it will use $20 million to advance the development of one of its off-the-shelf CAR-T programs and $30 million to develop “new human therapeutics approaches based on our proprietary gene editing technology outside of oncology.” If there are any other funds available from the IPO, Cellectis said it will use them for “working capital and other general corporate purposes.”
Last year Cellectis saw a brief stumble with its solely owned product, UCART123. The U.S. Food and Drug Administration placed a clinical hold on two Phase I trials. UCART123 is being developed for acute myeloid leukemia) and blastic plasmacytoid dendritic cell neoplasm (BPDCN). The hold was placed on the trial following a death due to a grade 2 cytokine-release syndrome (CRS), a known safety concern for CAR-T programs. Similar safety problems forced Juno Therapeutics to pull the plug on its CAR-T program, JCAR015. In November 2017 the FDA released its hold on the studies following dosing changes and Choulika told BioSpace back in January that the company was moving forward with its programs.
In addition to UCART123 Cellectis is also developing UCART19 with Servier and Pfizer Inc.. Earlier this month Pfizer licensed its part of the CAR-T program to a new startup company, Allogeneco-founded by former Kite Pharma executives, Arie Belldegrun, and David Chang. Last year Kite, now owned by Gilead Sciences, won approval for its CAR-T treatment, the second in the United States. Cellectis said it will continue its relationship with Allogene. If Allogene is successful in developing UCART19 into a commercial product that could mean a lucrative payday for Cellectis.
Cellectis aims to file an Investigational New Drug Application for UCART22 for non-Hodgkin’s lymphoma later this year. The company has hopes this CAR-T will be able to treat patients who have relapsed. By 2019 Cellectis hopes to have a fourth CART in the clinic. UCARTTX1 will be developed for multiple myeloma.By Ddu
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