Immutep Announces First-in-Human Phase I Study of IMP761 Progresses to Dose Escalation Portion of Trial
Immutep (ASX: IMM; NASDAQ: IMMP) has announced progress in its first-in-human Phase I study of IMP761, a novel LAG-3 immunotherapy for autoimmune diseases. The study, conducted at the Centre for Human Drug Research in Leiden, Netherlands, has completed Part A (single dose) with no safety issues. It has now advanced to Part B, the dose escalation phase, where single dosing will increase from 0.03 mg/kg to 0.90 mg/kg.
The trial will assess both safety and pharmacokinetic/pharmacodynamic (PK/PD) modeling in 30 healthy volunteers. Pending safety clearance, it will proceed to Part C, involving multiple ascending doses in 14 subjects. The study incorporates a unique keyhole limpet haemocyanin (KLH) challenge model to evaluate IMP761's pharmacodynamic activity early in clinical development.
Immutep expects to release initial safety data before the end of the year, with PK/PD relationship assessments following in the first half of 2025.
- Phase I study of IMP761 has progressed to dose escalation phase
- No safety issues reported in the completed single-dose part of the trial
- Unique KLH challenge model implemented to evaluate pharmacodynamic activity early in clinical development
- Initial safety data expected before year-end 2024
- None.
Insights
The progression of Immutep's Phase I study for IMP761 to the dose escalation phase is a positive development, albeit with immediate impact. Key points:
- The single-dose part (Part A) has been completed with no safety issues, allowing the trial to advance.
- The dose escalation phase (Part B) will test doses from
0.03 mg/kg to0.90 mg/kg in 30 healthy volunteers. - The study incorporates a KLH challenge model to assess pharmacodynamic activity early on, which is innovative and could provide valuable insights.
- First safety data is expected by year-end, with PK/PD relationships to be assessed in H1 2025.
While this progress is encouraging for Immutep's pipeline, it's important to note that this is still an early-stage trial. The real value will come from the upcoming data readouts, which will inform the drug's safety profile and potential efficacy. Investors should view this as a positive step, but one that doesn't yet significantly alter the company's near-term prospects or valuation.
Media Release
First safety data anticipated before year end with assessment of PK/PD relationships to follow in H1’CY2025
SYDNEY, AUSTRALIA, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), 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. For more information on the trial, please visit clinicaltrials.gov (NCT06637865).
About IMP761
IMP761, a first-in-class immunosuppressive LAG-3 agonist antibody, has the potential to address the root cause of many autoimmune diseases by specifically silencing autoimmune memory T cells that accumulate at disease sites and restoring balance to the immune system. As published in the Journal of Immunology, encouraging pre-clinical in vivo and in vitro studies show IMP761 inhibits peptide-induced T cell proliferation, activation of human primary T cells, and an antigen-specific delayed-type hypersensitivity (DTH) reaction. Additional preclinical data in oligoarticular juvenile idiopathic arthritis (o-JIA) published in Pediatric Research details how IMP761 led to a decrease in a broad spectrum of effector cytokines in just 48 hours. This study also showed children with o-JIA have a skewed LAG-3 metabolism and suggested they can benefit from agonistic LAG-3 activity.
About Immutep
Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.
Australian Investors/Media:
Catherine Strong, Sodali & Co.
+61 (0)406 759 268; catherine.strong@sodali.com
U.S. Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
FAQ
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