FDA side­swipes Ne­oleukin with clin­i­cal hold on lead im­munother­a­py can­di­date, sends shares plum­met­ing

Nat­ur­al killer and CD8 T cells for on­col­o­gy have been a hotbed of in­vest­ment in re­cent years, with some Big Phar­ma play­ers dab­bling in the ef­fort. A small­er com­peti­tor, Seat­tle’s Ne­oleukin Ther­a­peu­tics, hoped to give its IL-2 in­no­va­tor a shot at boost­ing those cells with­out the tox­i­c­i­ty con­cerns, but the FDA had oth­er ideas.

The FDA has placed a clin­i­cal hold on Ne­oleukin’s IND ap­pli­ca­tion for NL-201, a de no­vo cy­tokine re­cep­tor ag­o­nist for IL-2 and IL-15, which it hoped to test in ex­pand­ing CD8 T cells and nat­ur­al killer cells for use in on­co­log­ic ther­a­peu­tic ar­eas, the com­pa­ny said Fri­day.

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