Immunocore announces initial Phase 1 data for IMC-M113V

Immunocore has presented at the Conference on Retroviruses and Opportunistic Infection, CROI, the first safety and activity data with IMC-M113V, a bispecific soluble TCR therapy built on Immunocore’s ImmTAX technology which is being developed for the treatment of people living with HIV. Initial Phase 1 trial data: In the single ascending dose part of the trial, three dose levels of IMC-M113V, given as a single IV infusion, were evaluated: a starting dose of 1.6 mcg, based on the minimum anticipated biological effect level (n=1), 5 mcg (n=1) and 15 mcg (n=10). All doses were well tolerated. There were no serious adverse events, significant changes in hematology or chemistry, nor cytokine release syndrome or neurotoxicity. Plasma viral load remained suppressed throughout dosing and follow-up. In addition, transient, dose-dependent increases in serum IL6 occurred 8-24 hours post-infusion. Five out of the ten participants who received the 15-mcg dose showed a greater than4-fold rise in IL6, which had been prespecified as indicative of pharmacodynamic activity based on prior experience from clinical trials with KIMMTRAK, the Company’s first ImmTAX therapy now approved for the treatment of metastatic or unresectable uveal melanoma.