In an ef­fort to mar­ry T cell and nat­ur­al killer cell tech­nolo­gies for the treat­ment of blood can­cer, Dutch biotech Kiadis has inked an all-stock deal to ac­quire US-based Cy­toSen Ther­a­peu­tics.

Arthur Lahr

Both com­pa­nies have had the same goal: to boost the chances of can­cer pa­tients un­der­go­ing hematopoi­et­ic stem cell trans­plants by su­per­charg­ing their im­mune sys­tem while their bone mar­row re­cov­ers from the pro­ce­dure. Kiadis does this with en­gi­neered T cells; Cy­toSen chose NK cells, de­signed to at­tack any re­main­ing ma­lig­nant cells that could lead to a re­lapse. Both tech­nolo­gies take cells from a fam­i­ly mem­ber of the pa­tient so that the im­mune cells would be par­tial­ly matched.

Aside from a new tech plat­form, Kiadis al­so scored a net­work of promi­nent col­lab­o­ra­tors on Cy­toSen’s found­ing team, in­clud­ing Dean Lee of Na­tion­wide Chil­dren’s Hos­pi­tal, Ste­fan Ciurea of the MD An­der­son Can­cer Cen­ter and Robert Igarashi from the Uni­ver­si­ty of Cen­tral Flori­da. Carl June, the pi­o­neer­ing CAR-T ex­pert, is al­so join­ing its sci­en­tif­ic ad­vi­so­ry board.

UCF first came up with the Cy­toSen method, which de­rives nanopar­ti­cles from anti­gen pre­sent­ing cells to stim­u­late pro­lif­er­a­tion of NK cells. Na­tion­wide fur­ther re­fined it, and the first hu­man stud­ies were con­duct­ed at MD An­der­son.

Carl June

The com­pa­ny, which is list­ed on Eu­ronext Am­s­ter­dam and Brus­sels ($KDS) now ex­pects to take Cy­toSen’s lead pro­gram, CS­DT002-NK, in­to the clin­ic in 2020, tar­get­ing high-risk acute myeloid leukemia pa­tients. Ear­li­er proof-of-con­cept da­ta from 25 pa­tients had demon­strat­ed a re­lapse rate of 8% and pro­gres­sion-free sur­vival of 66%, ac­cord­ing to a press re­lease.

Mean­while, Kiadis’ ATIR101 is un­der re­view in Eu­rope for a mar­ket­ing ap­proval, with a po­ten­tial launch planned for this year.

“The ATIR T-cell and CS­DT002-NK-cell pro­grams each have the po­ten­tial to make trans­plants safer and more ef­fec­tive,” CEO Arthur Lahr said. “In com­bi­na­tion, they have the po­ten­tial to rev­o­lu­tion­ize HSCT, mak­ing it suit­able for an even wider group of pa­tients.”

Per the deal, Cy­toSen in­vestors — who have re­mained un­named — will gain a 7.4% stake in Kiadis, or 1.94 mil­lion shares. They are el­i­gi­ble to re­ceive up to 5.82 mil­lion more shares should de­vel­op­ment and reg­u­la­to­ry mile­stones be reached.

The com­bined en­ti­ty will have $55.4 mil­lion (€ 49 mil­lion) from Kiadis and $6 mil­lion from Cy­toSen to work with.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

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