Australian immunotherapy developer Immutep (ASX:IMM) has secured one of the most significant commercial partnerships in its history, signing a strategic collaboration and exclusive licensing agreement with India’s Dr. Reddy’s Laboratories for the development and commercialisation of its lead drug candidate, eftilagimod alfa (efti), across most global markets.
Under the deal, which excludes North America, Europe, Japan and Greater China, Immutep will receive an upfront payment of US$20 million (~A$30.2 million) and is eligible for a further US$349.5 million (~A$528.4 million) in regulatory, development and commercial milestone payments. The company will also earn double-digit royalties on future sales in those licensed territories.
The agreement marks a pivotal step in Immutep’s bid to bring its first-in-class immunotherapy to market. Efti, a soluble LAG-3 protein and MHC Class II agonist, is designed to activate antigen-presenting cells and trigger a broad anti-cancer immune response. It is currently being tested in the registrational Phase 3 TACTI-004 (KEYNOTE-F91) trial for first-line advanced or metastatic non-small cell lung cancer. It is also being evaluated in trials for head and neck cancer, breast cancer, and soft tissue sarcoma.
Dr. Reddy’s CEO for Branded Markets (India and Emerging Markets), M.V. Ramana, said the partnership aligned with the company’s commitment to expanding access to cutting-edge oncology therapies.
“This collaboration marks our continuous efforts to deliver first-in-class and innovative therapies for cancer treatment. Efti is a novel immunotherapy with the potential to set a new standard of care in combination with pembrolizumab (Keytruda) and chemotherapy as first-line therapy for non-small cell lung cancer. Its broad potential extends to other major cancers across multiple stages of disease. Through this agreement, we look forward to leveraging our expertise and strong market access to advance the development and commercialisation of this promising cancer therapy in the licensed markets,” Ramana said.
Immutep Chief Executive Marc Voigt said the licensing deal not only validates the scientific promise of efti but positions the company firmly for the next phase of its commercial evolution.
“This agreement with Dr. Reddy’s marks a significant milestone for Immutep and further validates the potential of efti. Dr. Reddy’s proven capabilities and reach in the licensed markets make them an ideal partner to maximise the impact of our innovation and serve a large number of patients across the globe. Additionally, this partnership allows us to capture significant value for efti in the licensed markets, while retaining full rights in key markets such as North America, Europe, and Japan, and ensures we remain very well-positioned for future value creation,” he said.
While Dr. Reddy’s takes responsibility for development and commercialisation in a wide expanse of markets, Immutep has retained global manufacturing rights, ensuring continued control over production as efti moves toward regulatory filings and potential approvals. The deal also allows Immutep to preserve full ownership of the product in major pharmaceutical markets where any eventual commercial opportunities would be substantial.
Efti’s mechanism—direct activation of antigen-presenting cells through MHC Class II engagement—distinguishes it from PD-1/PD-L1 or CTLA-4 inhibitors. Early-stage studies have shown a favourable safety profile, enabling combination approaches with checkpoint inhibitors, radiotherapy and chemotherapy.
The drug has already been granted Fast Track designation by the U.S. FDA for first-line NSCLC and first-line head and neck cancer, further underscoring its therapeutic promise.