How Immutep’s A$30M Deal with Dr. Reddy’s Accelerates Cancer Immunotherapy Trials

Strategic Collaboration Bolsters Immutep’s Commercial Prospects

Immutep Limited has taken a significant step forward by entering into a strategic collaboration with Dr. Reddy’s Laboratories for the development and commercialisation of its lead immunotherapy candidate, eftilagimod alfa (efti), outside North America, Europe, Japan, and Greater China. This agreement has already delivered an upfront payment of approximately A$30 million, with the potential to earn up to A$528 million in milestone payments plus royalties on sales. The deal not only validates Immutep’s innovative approach but also provides a robust financial foundation to support its global clinical programs.

Clinical Trials Show Encouraging Progress Across Multiple Cancers

Immutep’s Phase III trial TACTI-004 (KEYNOTE-F91), evaluating efti combined with Merck’s KEYTRUDA and chemotherapy in first-line non-small cell lung cancer (NSCLC), continues to advance steadily. With over 38% of the targeted 756 patients enrolled and regulatory approvals in 27 countries, the trial is on track to complete its futility analysis in early 2026. This trial aims to improve response rates across all PD-L1 expression levels, potentially setting a new standard of care in this large oncology segment.

Complementing this, data from the INSIGHT-003 Phase I trial presented at ESMO 2025 demonstrated that the efti-KEYTRUDA-chemotherapy combination achieved a 61.7% objective response rate in patients with low or no PD-L1 expression, outperforming historical controls. This is particularly notable as these patients typically respond poorly to PD-1 inhibitors.

In soft tissue sarcoma, the EFTISARC-NEO Phase II trial met its primary endpoint with a median tumour hyalinization/fibrosis of 51.5%, a surrogate marker linked to improved survival. Translational data further confirmed strong immune activation consistent with efti’s mechanism. The trial’s recognition with a prestigious Golden Scalpel Award in Poland underscores its innovative potential.

Meanwhile, the AIPAC-003 Phase II/III trial in metastatic breast cancer reported strong response and disease control rates in heavily pretreated patients, with the FDA endorsing 30 mg as the optimal biological dose for efti. Immutep is also progressing a new Phase II trial evaluating neoadjuvant efti in early-stage hormone receptor-positive breast cancer.

Advancing Autoimmune Program and Intellectual Property

Beyond oncology, Immutep’s IMP761, a first-in-class LAG-3 agonist antibody targeting autoimmune diseases, completed early dosing levels in a Phase I trial with encouraging safety and immunosuppressive effects. Additional data presentations are expected in the first half of 2026. The company also secured four new patents, reinforcing its intellectual property position.

Financial Position Supports Long-Term Development

Immutep’s financial health remains strong, with a cash, cash equivalents, and term deposit balance of A$99.1 million as of December 31, 2025. The subsequent receipt of the Dr. Reddy’s upfront payment lifts this to a pro-forma A$129.3 million, extending the company’s cash runway well into the second quarter of 2027. Additionally, a deferred vendor payment arrangement of approximately A$30 million provides further flexibility in managing development costs.

Overall, Immutep’s latest quarterly report highlights a company advancing multiple promising immunotherapy programs with solid financial backing and strategic partnerships, positioning it well for upcoming clinical milestones and commercial opportunities.