Immutep Limited (NASDAQ: IMMP) shares were virtually unchanged Thursday. Immutep, a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces that the first part (Part A, single dose) of the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761 has been fully recruited and the drug has been administered with no safety issues.
The trial being conducted by the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands, has now progressed to the Part B dose escalation phase with single IMP761 dosing planned to move from 0.03 mg/kg up to 0.90 mg/kg. Both safety and pharmacokinetic/pharmacodynamic (PK/PD) modeling will be assessed in this second cohort of healthy volunteers (N=30). Pending no safety issues, the trial will then shift to the multiple ascending dose portion (Part C) in 14 subjects in which PK will be further evaluated.
CHDR will implement its unique keyhole limpet haemocyanin (KLH) challenge model in Parts B and C of this Phase I study, allowing for the evaluation of IMP761’s pharmacodynamic activity at this early stage of clinical development.
Immutep anticipates the first safety data from the trial to be available before year end with assessment of PK/PD relationships to follow in the first half of CY2025.
IMMP shares dipped three cents, or 1.5%, in price to $2.01.