I hope that this newsletter finds you and your families safe and well.
I am pleased to report that the Immutep team is helping to lead the LAG-3 therapeutic space as we advance the development of exciting cancer and autoimmune therapies aimed at improving patients’ lives. We remain fully committed to this space and currently have more LAG-3 programs under development than any other biotech or pharma. In addition, our lead candidate eftilagimod alpha, or “efti”, is unique due to its mechanism of action and has no comparators.
Over the past several months, we reached a transformational period in our company’s history as we moved ahead with two late-stage trials in the pipeline, of which one has started and one is in a planning process.
Our late-stage study TACTI-003, is being conducted through our second collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada). TACTI-003 is a Phase IIb trial in first line Head and Neck Squamous Cell Carcinoma (HNSCC) that evaluates efti in combination with MSD’s KEYTRUDA® (pembrolizumab) as a first line therapy in approximately 154 patients with HNSCC. This is a randomised, controlled clinical study that will take place across Australia, Europe and the U.S. in up to 35 clinical sites. If the results from this Phase IIb trial are sufficiently positive, we expect it to provide us with registration data to submit to the relevant competent authorities. As a reminder, we were granted Fast Track designation for efti to treat first line HNSCC patients by the U.S. FDA in early April 2021. This collaboration and study builds upon the robust data from TACTI-002 that showed this therapeutic combination provided sustained and durable responses in the second line HNSCC setting, which were reported in June at ASCO and in November at SITC.
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