The company reported that additional financing from existing shareholders, to the tune of over £40m (US$54.1m), will accelerate its proprietary multi-cell and targeted nanoparticle technologies.
Asked why there was a need for a company name change, Joe Dupere, Ixaka CEO, told BioPharma-Reporter:
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.
“The company has doubled in size and brought together two exciting technology platforms around which we have wrapped full capabilities encompassing world-leading science and medicine, late-stage clinical and regulatory development and a range of advanced therapy manufacturing capabilities. We have renamed it in recognition of this transformation and new direction for the company.”
Ixaka’s proprietary technologies – concentrated multi-cell therapies (MCTs) and targeted nanoparticle (TNP) therapeutics – are said to enhance the naturally therapeutic power of cells and target a broad range of serious diseases, including cancers and genetic, neurological and autoimmune diseases.
REX-001, Ixaka’s lead MCT product, is an autologous cell-based product in clinical development for the treatment of chronic limb-threatening ischaemia (CLTI). REX-001 is currently being evaluated in the pivotal Phase III SALAMANDER clinical trial at multiple sites across Europe.
“The two technology platforms are very complementary as they both enable the boosting of activity of naturally therapeutic cells for a broad range of diseases. The combination also enables the company to put in place a broad range of capabilities from early science to commercialization,” explained the CEO.
Nanoparticle technologies
Ixaka’s polymeric TNP 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 (CAR) T-cell therapies in vivo for hematological malignancies.
Ixaka’s TNP platform involves a nanoparticle, coated with targeting molecules, which enable the particle to attach to the target cell and transfect. The particle contains a lentivirus containing both a cell-specific promoter and the gene of interest. The nanoparticle is stable and can be injected to transfect the gene of interest directly in the body, said Dupere.
“The lead TNP product targets T-cells to create a CD19 CAR which will then attack cancer cells. This is a major advance over ‘ex vivo’ CAR T-cells where the transfected T cell is exhausted after many rounds of replication as well as being very challenging to standardize in manufacturing and very expensive to produce. Several world-renowned labs have also explored the nanoparticle approach, but we believe Ixaka’s TNP products have a potentially significantly improved efficacy and safety profile,” he continued.
Future financing
Following the restructuring and name change, the company is looking at a range of financing options to support the current programs through to clinical development, to expand into new indications, and to develop commercial manufacturing and market access capabilities, added the CEO.
The company noted that the advanced therapy sector demonstrated remarkable resilience in the first half of 2020 in spite of the focus on COVID-19 therapies and vaccines.
A total of US$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, it said, citing a report from Alliance for Regenerative Medicine.
