After a tricky patch in 2017, the stars seem to be coming back into alignment for French CAR-T specialist Cellectis, which has just closed a $164 million U.S. public offering. Around $100 million of the new funding will be used to build commercial capabilities including a manufacturing plant for its CAR-T candidates. The candidates—which use donated cells rather than cells harvested from individual patients like currently approved CAR-Ts from Novartis and Kite Pharma/Gilead—should in theory be cheaper to make and deliver. In an SEC filing, Cellectis also said it would spend $20 million to take another program into clinical development and had earmarked $30 million to explore the use of its gene-editing tech outside oncology. Virtual Clinical Trials Online This virtual event will bring together industry experts to discuss the increasing pace of pharmaceutical innovation, the need to maintain data quality and integrity as new technologies are implemented and understand regulatory challenges to ensure compliance. Last year the biotech was knocked back by an FDA clinical hold on its CAR-T therapy UCART123 for acute myeloid leukemia after a death due to cytokine-release syndrome (CRS), a recognized but serious safety issue with this type of cancer immunotherapy. The hold was relaxed in November after Cellectis proposed dosing changes and other modifications to the protocol of its two phase 1 trials of the therapy. There’s still no guarantee that UCART123 will not suffer the fate of Juno’s former lead candidate JCAR015, which was also hit by CRS and abandoned last year. However, other events are also starting to go Cellectis’ way. The biotech’s longstanding partnership with Pfizer for 17 off-the-shelf CAR-Ts has just been converted into new company Allogene, headed by Arie Belldegrun and David Chang, who led the development of Kite Pharma’s non-Hodgkin lymphoma treatment. The SEC filing noted that Allogene has assumed all of Pfizer’s obligations—which could generate up to $2.8 billion for Cellectis—and has also taken over U.S. rights to lead CAR-T UCART19 for acute lymphoblastic leukemia, which is licensed to Server elsewhere. And with a hefty $300 million in startup funding, the new company has everything in place to bring the first allogeneic (off-the-shelf) CAR-T to market, perhaps as soon as 2020. Goldman Sachs, Citigroup and Barclays acted as book-running managers for the U.S. offering, while Nomura acted as lead manager and Oppenheimer and Ladenburg Thalmann were co-managers.
Cellectis has raised $ 164 m from a US public offering to expand its CAR - T and gene - editing capabilities . The French company is planning to spend $ 100 m of the funding on further commercial production , including setting up a manufacturing facility for its CAR - T candidates , $ 20 m on further clinical development on another programme and $ 30 m to develop its gene - editing technology for non - oncological uses . Meanwhile , Cellectis ’s partnership with Pfizer for 17 readymade AR - Ts has been converted into a new company , Allogene , which has taken over the rights to lead CAR - T UCART19 for acute lymphoblastic leukaemia , and is backed by $ 300 m of funding .