Immutep (IMM) Bell Potter Healthcare Conference 2025 summary

Clinical development progress

• Lead drug candidate eftilagimod alpha is in a global phase III trial for non-small cell lung cancer, aiming to change first-line treatment standards and improve patient survival.

• Phase III trial involves 756 patients across more than 150 sites in over 25 countries, with robust design and stratification factors to ensure balanced results.

• Recruitment is on track, with futility analysis expected in Q1 next year and final progression-free survival readout anticipated between late 2026 and mid-2027.

• Previous phase I/II trials, including INSIGHT-003 and TACTI-002, showed strong safety and efficacy, with tumor shrinkage rates exceeding historical controls and median overall survival over 30 months.

• Additional updates from ongoing trials in metastatic breast cancer, soft tissue sarcoma, and INSIGHT-003 are expected within the next 12 months.

Strategic partnerships and regulatory engagement

• Collaboration with Merck provides Keytruda supply valued at $100 million and joint trial design, marking Merck's first such phase III partnership in over two years.

• Regulatory alignment achieved with FDA, EMA, and other agencies, supporting the global scope and integrity of the phase III trial.

• Ongoing joint development committee with Merck ensures pharma-standard trial execution and frequent operational touchpoints.

Pipeline expansion and innovation

• IMP761, a LAG-3 pathway candidate for autoimmune diseases, is in phase I dose escalation, showing promising immunosuppressive effects in healthy volunteers.

• IMP761 targets the root cause of autoimmune diseases, with potential applications in rheumatoid arthritis, psoriasis, and type 1 diabetes.

• Soft tissue sarcoma trial met its primary endpoint with highly significant results and strong biomarker correlation, supporting the drug's mechanism of action.