Leiden University Medical Center and Ixaka enter collaboration to strengthen knowledge of cell therapy candidate REX-001

30/03/2021

Ixaka Ltd and Leiden University Medical Center (LUMC) today announce a research collaboration to expand understanding of Ixaka’s lead multi-cell therapy product REX-001.

Under the collaboration, LUMC will work to support and accelerate development of REX-001, Ixaka’s autologous cell-based product in Phase III clinical development for the treatment of chronic limb-threatening ischemia (CLTI). The project will involve pre-clinical in vitro and in vivo studies to gain new insights into the complex role of progenitor and immune cells in the mechanism of action of REX-001 involved in improving clinical outcomes. The work will be led by Professor Paul Quax, Professor of Experimental Vascular Medicine at LUMC.

Professor Paul Quax, Professor of Experimental Vascular Medicine at Leiden University Medical Center, added: “Chronic limb-threatening ischemia is a serious, life-threatening vascular disease, with poor prognosis and limited treatment options as the disease progresses. The current surgical procedures used to manage the symptoms are often unsuitable or ineffective in advanced disease stages, creating a critical need for new and innovative therapies. REX-001 has demonstrated great results for patients in Phase I/II and Phase II studies, and I look forward to working with Ixaka to further elucidate the molecular and cell mechanisms of this promising advanced regenerative therapy.”

REX-001 is currently being evaluated in the pivotal Phase III SALAMANDER clinical trial (NCT03111238) in patients with CLTI at multiple sites across Europe. The experimental work performed at LUMC will support regulatory filings for REX-001.

Joe Dupere, CEO of Ixaka, commented: “Leiden University Medical Center is an internationally renowned research institution with proven expertise in cell and gene therapies and vascular medicine, making it the perfect partner to aid development of our multi-cell therapy product REX-001. The unique combination of immune and progenitor cells used in REX-001 has demonstrated high efficacy for the treatment of chronic limb-threatening ischemia through revascularization and ulcer healing in phase 2 studies, but a better understanding of the underlying mechanism of action will be very valuable as we progress our Phase III clinical trial and prepare our application for market authorization.”

REX-001 consists of a combination of immune and progenitor cells that are extracted from a patient’s own bone marrow. The cells are processed to enhance the natural therapeutic power of the cells and re-administered directly to the site of occluded blood vessels. Locally administered REX-001 acts to regenerate blood vessels, modulate immune responses, improve blood flow, improve tissue oxygenation and promote wound healing. These effects lead to a significant improvement in clinical outcome and quality of life through complete ulcer healing and alleviation of chronic ischemic rest pain.

Professor Quax specialises in experimental vascular surgery. He is Board member of Leiden Vascular Medicine; Board member of the Dutch Atherosclerosis Society; an Established Investigator of the Netherlands Heart Foundation; and a Fellow of the American Heart Association.

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