Immutep Limited (ASX: IMM; NASDAQ: IMMP) has announced that its first-in-human Phase I study of IMP761, a novel LAG-3 immunotherapy, has advanced to the dose escalation phase after successfully completing the initial single-dose portion of the trial. The study, conducted by the Centre for Human Drug Research (CHDR) in Leiden, the Netherlands, reported no safety issues during the first part (Part A, single dose) of the placebo-controlled, double-blind trial.
Dose Escalation and Study Design
The trial is now progressing to Part B, which involves dose escalation with single IMP761 doses planned to increase from 0.03 mg/kg up to 0.90 mg/kg. This phase will involve a cohort of 30 healthy volunteers and will assess both safety and pharmacokinetic/pharmacodynamic (PK/PD) modeling. Pending the absence of safety concerns, the trial will move to the multiple ascending dose portion (Part C), involving 14 subjects, to further evaluate PK.
Pharmacodynamic Activity Evaluation
CHDR will employ its keyhole limpet haemocyanin (KLH) challenge model in Parts B and C of the Phase I study. This model will allow for the evaluation of IMP761’s pharmacodynamic activity at this early stage of clinical development, providing crucial insights into the drug's mechanism of action and potential efficacy.
Anticipated Data Release
Immutep anticipates releasing the first safety data from the trial before the end of the year. Assessment of PK/PD relationships is expected to follow in the first half of CY2025. Additional details about the trial can be found at clinicaltrials.gov (NCT06637865).
