LONDON, UK and LEIDEN, The Netherlands I March 30, 2021 I 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.

About Chronic Limb-Threatening Ischemia

Chronic limb-threatening ischemia (CLTI) is the most serious form of peripheral arterial disease (PAD), in which a build-up of fatty deposits in the arteries restricts blood supply to leg muscles. In CLTI, normal immune responses are downregulated leading to exacerbated inflammation and reduced regeneration; this leads to a clinical deterioration, reduced quality of life and life expectancy.

CLTI is characterized by chronic ischemic pain at-rest, ulcers and/or gangrene in one or both legs. There are currently no approved therapies to successfully treat ischemic leg ulcers. State-of-the-art minimally invasive catheter procedures and surgical reconstruction are ineffective in restoring blood flow, healing ulcers and preventing major amputations.

About Ixaka

Ixaka is a cell and gene therapy company focused on using the natural powers of the body to cure disease.

Ixaka’s proprietary technologies enhance the naturally therapeutic power of cells by increasing the presence of curative cells at the site of disease, or by directly modifying cells within the body to improve disease targeting and boost their restorative effect.

Ixaka’s technologies – concentrated multi-cell therapies and nanoparticle therapeutics – demonstrate potential for the treatment of a broad range of serious diseases across oncology, cardiovascular, neurological and ocular diseases, and genetic disorders.

Ixaka has offices in London, UK with R&D and manufacturing operations in Seville, Spain and Paris, France and additional manufacturing capability in Frankfurt, Germany.

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About Leiden University Medical Center

As a centre for medical innovation, Leiden University Medical Centre (LUMC) strives for a (inter)nationally recognized leading role in improving the quality of healthcare. The core tasks of the LUMC are research, education, patient care, training and continuing education. The LUMC is part of the Dutch Federation of University Medical Centres (NFU). The NFU is an alliance of the eight university medical centres (UMCs) in the Netherlands.