19 January 2021 - - UK-based integrated cell and gene therapy company Ixaka Ltd has launched, the company said.

The company's shareholders have funded the business with over GBP 40m in financing.

Previously Rexgenero Ltd, a UK-based company pioneering the development of cell therapies to treat serious diseases such as cancer and chronic limb-threatening ischaemia, the launch of Ixaka follows integration of its nanoparticle gene therapy business in France and a shareholder restructuring.

The new business will continue to develop Ixaka's proprietary technologies concentrated multi-cell therapies and targeted nanoparticle therapeutics.

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

REX-001, Ixaka's lead MCT product, is an autologous cell-based product in clinical development for the treatment of CLTI. REX-001 is currently being evaluated in the pivotal Phase III SALAMANDER clinical trial at multiple sites across Europe.

Ixaka's polymeric nanoparticle platform can be used to perform genetic modifications directly inside a patient's body. The platform enables in vivo targeting and transduction of T cells, and is currently being applied to generate chimeric antigen receptor T-cell therapies in vivo for haematological malignancies.

Modifications of the components will allow the technology to target a broad range of serious diseases, including cancers and genetic, neurological and autoimmune diseases.

A total of USD 15.4bn was raised in the first half of 2020 for the development of cell and gene therapies, with 1,078 regenerative medicine and advanced therapy clinical trials ongoing worldwide.

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

The company'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 and D and manufacturing operations in Seville, Spain and Paris, France and additional manufacturing capability in Frankfurt, Germany.

Multi-cell therapies are derived from natural tissue extracts which are selected for the most active cells, removing components (such as red blood cells and platelets) that potentially reduce the activity of therapeutic cells.

Its first MCT is REX-001, which is currently in a multi-site Phase 3 clinical trial for chronic limb-threatening ischemia.

Ixaka's REX-001 MCT consists of a combination of progenitor cells and immune cells (lymphocytes, monocytes and granulocytes) which are selected and concentrated from a patient's own bone marrow and administered directly to the site of occluded blood vessels in the lower leg.

Locally administered REX-001 acts to regenerate blood vessels (through both direct and indirect paracrine mechanisms), modulate immune responses, improve blood flow, improve tissue oxygenation, and promote wound healing.

These effects lead to a significant improvement in clinical outcomes and quality of life through complete ulcer healing and alleviation of chronic ischemic rest pain.

Ixaka's targeted nanoparticle therapeutic is a platform which enables therapeutic cells to be targeted and genetic modifications to be performed directly inside the body.

The first application is in the generation of chimeric antigen receptor T-cell therapies for haematological malignancies.

Modifications of the components however allows the technology to target a range of therapeutic cells for the treatment of many serious diseases including cancers, genetic disorders, neurological, autoimmune and ocular diseases.

The TNP in vivo gene delivery approach enables targeting of specific cells and expression of the gene of interest directly in the patient.

The technology is also targeted and controllable offering potentially improved efficacy and safety.

Generation of enhanced therapeutic cells through genetic modification inside the body also enables more standardized manufacturing which is less expensive as it does not require costly dedicated manufacturing sites needed to expand cells before use (as is required for ex vivo cell therapies).