Immutep Quarterly Activities Report and Appendix 4C
| Stock | Immutep Ltd (IMM.ASX) |
|---|---|
| Release Time | 29 Jan 2026, 11:36 a.m. |
| Price Sensitive | Yes |
Immutep Quarterly Activities Report and Appendix 4C
- Entered into strategic collaboration with Dr. Reddy's for commercialisation of eftilagimod alfa (efti) in all countries outside North America, Europe, Japan, and Greater China
- Strong operational progress reported for TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in first line non-small cell lung cancer (1L NSCLC)
- Data from INSIGHT-003 show combination of efti with KEYTRUDA® and chemotherapy generates strong response rates across all PD-L1 expression levels in 1L NSCLC
Immutep Limited, a late-stage immunotherapy company, provided an update on its activities for the quarter ended 31 December 2025 (Q2 FY26). Most significantly, Immutep entered into a strategic collaboration with Dr. Reddy's for the development and commercialisation of eftilagimod alfa (efti) in all countries outside North America, Europe, Japan, and Greater China. Immutep received a USD 20 million (~AUD 30.2 million) upfront payment and is eligible for up to USD 349.5 million (~AUD 528.4 million) in potential regulatory and commercial milestones, plus royalties. Immutep reported strong operational progress in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in combination with KEYTRUDA® and chemotherapy as first-line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC). The trial has enrolled over 38% of the targeted 756 patients, with the futility analysis on track for Q1 2026. Data from the INSIGHT-003 trial showed the combination of efti with KEYTRUDA and chemotherapy generated strong response rates across all PD-L1 expression levels in 1L NSCLC, including a 61.7% objective response rate in patients with low and no PD-L1 (TPS <50%). In the EFTISARC-NEO Phase II trial, the primary endpoint was met, with a median 51.5% tumour hyalinization/fibrosis in the evaluable patient population, exceeding the prespecified 35% target. Immutep also reported positive data from the AIPAC-003 Phase II trial in metastatic breast cancer and continued progress with a new investigator-initiated Phase II trial evaluating neoadjuvant efti in HR+/HER2-negative breast cancer. The company's cash position as of 31 December 2025 was approximately AUD 99.1 million, which was further strengthened by the ~AUD 30.2 million upfront payment from Dr. Reddy's, extending Immutep's cash reach well into Q2 2027.
Immutep is eligible to receive up to ~AUD 528.4 million in potential regulatory development and commercial milestone payments from Dr. Reddy's, plus royalties on commercial sales of efti in the licensed markets.
Immutep continues to advance its clinical trial programs for efti in oncology and IMP761 in autoimmune diseases. The company expects to reach 50% of the patient enrolment target for the TACTI-004 Phase III trial soon and anticipates providing further updates on the INSIGHT-003 and EFTISARC-NEO trials, as well as the IMP761 Phase I study, in the first half of 2026.