Ex­clu­sive: Carl June’s Tmu­ni­ty en­coun­ters a lethal road­block as 2 pa­tient deaths de­rail lead tri­al, raise red flag forc­ing a re­think of CAR-T for sol­id tu­mors

The mul­ti­fac­eted cam­paign to cre­ate a CAR-T for sol­id tu­mors has run in­to a lethal prob­lem.

In ex­clu­sive in­ter­views, Tmu­ni­ty founders Carl June and Oz Azam tell me that they have had to scrap their lead pro­gram for prostate can­cer fol­low­ing the deaths of 2 pa­tients ear­li­er in the year — the last a lit­tle more than a month ago — af­ter they ex­pe­ri­enced lethal bouts of neu­ro­tox­i­c­i­ty. What start­ed as a vol­un­tary halt by Tmu­ni­ty in the face of these deaths flipped to an FDA-en­forced red light for the clin­i­cal tri­al, while the biotech scram­bled to re­work its CAR-T de­sign with a plan to get “ver­sion two” back in­to the clin­ic as soon as pos­si­ble, with a new IND planned for the sec­ond half of the year.

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