Immutep, a late-stage immunotherapy company targeting cancer and autoimmune diseases, and Dr. Reddy’s Laboratories announced that their respective wholly owned subsidiaries, Immutep SAS and Dr. Reddy’s Laboratories SA, have entered into a strategic collaboration and exclusive licensing agreement for the development and commercialisation of Eftilagimod Alfa (efti) in all countries outside North America, Europe, Japan, and Greater China.
Efti is Immutep’s first-in-class novel immunotherapy that directly activates the immune system to fight cancer. It is under evaluation in TACTI-004 (KEYNOTE-F91), a registrational Phase III trial for first-line therapy of advanced or metastatic non-small cell lung cancer. Efti is also being investigated in other indications including head and neck cancer, breast cancer, and soft tissue sarcoma.
The terms of the licensing agreement provide Immutep significant milestones and preserve its ability to capture material future upside in the licensed markets as efti advances commercially. Immutep holds the global manufacturing rights to the product across all markets and will supply the product to Dr. Reddy’s in the licensed markets, while retaining all rights in key pharmaceutical markets including North America, Europe, and Japan.
Under the agreement, Immutep will receive from Dr. Reddy’s an upfront payment of USD 20 million (~AUD 30.2 million). It is also eligible to receive potential regulatory development and commercial milestone payments of up to USD 349.5 million (~AUD 528.4 million), plus double-digit royalties on commercial sales in these markets.
“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,” stated M.V. Ramana, CEO – Branded Markets (India & Emerging Markets), Dr. Reddy’s.
“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,” said Marc Voigt, CEO of Immutep.
About Eftilagimod Alfa (Efti):
Efti is a first-in-class soluble LAG-3 protein and MHC Class II agonist delivered subcutaneously that uniquely activates antigen-presenting cells or APCs (e.g., dendritic cells, monocytes) via major histocompatibility complex (MHC) class II ligands. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating co-stimulatory signals and cytokines that boost the immune system’s ability to combat cancer.
Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. This has been demonstrated across early-stage trials in NSCLC and HNSCC, which have laid the foundation for the larger randomised clinical trial in NSCLC. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).