With the help of its technology platform, Xintela is developing new treatments in the fields of stem cell therapy and targeted cancer therapy, with focus on indications with a high unmet medical need.
Xintela's drug development in both stem cell therapy and cancer therapy is based on a unique marker technology platform that is based on specific cell surface markers (integrins).
Integrins are a family of cell surface proteins that regulate the function of cells in various body tissues and have long been used as target molecules in the development of therapies for, for example, inflammatory diseases and cancer. The marker technology is mainly based on the use of integrin α10β1 which was discovered by Evy Lundgren-Åkerlund's research group at Lund University. Lundgren-Åkerlund and colleagues have previously shown that integrin α10β1 is found on cartilage cells and is important for the function of cartilage cells and also on mesenchymal stem cells (MSC) that can develop into different cell types, including cartilage cells. This discovery is the basis for Xintela's selection of stem cells and the development of the patent-protected stem cell product XSTEM.
Research in Xintela's subsidiary Targinta has in recent years shown that integrin α10β1 is also found in certain aggressive cancer cells such as in triple-negative breast cancer and the brain tumor glioblastoma, which is the reason for Xintela's investment in oncology for the development of therapeutic antibodies targeting integrin α10β1.
In stem cell therapy, the stem cell marker integrin α10β1 is used to select and quality assure stem cells in the proprietary stem cell products XSTEM®, for the treatment of humans, and EQSTEM®, for the treatment of horses. Xintela has initiated clinical studies with the stem cell product XSTEM for the treatment of knee osteoarthritis and for the treatment of difficult-to-heal leg ulcers. The strategy is that further development of XSTEM for the treatment of ARDS (Acute Respiratory Distress Syndrome) takes place in collaboration with partners.
Xintela uses its proprietary stem cell marker, integrin α10β1, to select and quality assure stem cell products from donated fatty tissue from healthy individuals. XSTEM is patented both as a product and for therapeutic use in all indications. This gives Xintela the best conditions to develop safe and effective stem cell-based treatments for a variety of diseases.
Xintela’s stem cell products are produced in the company’s own GMP-approved manufacturing facility, which significantly reduces both production costs and risks of delays.
In Xintela's clinical trial (phase I/IIa), in patients with moderate knee osteoarthritis (Kellgren-Lawrence grade II-III), conducted in Australia. The study's Safety Review Committee has evaluated and declared the first and second dose levels as safe. Dosing at the third and last dose level is ongoing. The main goal of the study is to show that XSTEM is safe, but also to obtain preliminary results showing that the product has DMOAD (Disease Modifying Osteoarthritis Drug) properties and can slow cartilage and joint breakdown as well as repair damaged articular cartilage and improve joint function. Xintela's preclinical results provide strong support for XSTEM to have a DMOAD effect.
In the clinical study, three different dose levels are evaluated in 24 patients with the option to add additional patients up to 54 patients. Each patient will be followed for 18 months with continuous safety evaluation as well as preliminary efficacy evaluation every six months.
Read more about osteoarthritis below.
In Xintela's second clinical study (Phase I/IIa), in patients with severe leg ulcers, is recruitment of patients ongoing. The study will be conducted in collaboration with Professor Folke Sjöberg and his colleagues at Linköping University Hospital. 12 patients with difficult-to-heal venous leg ulcers will be treated in the study. XSTEM will be administrated to the wound and patients will then be followed for 10 weeks to evaluate safety and wound healing effect.
Read more about difficult-to-heal leg ulcers below.
Based on the company's unique marker technology, Xintela has also developed the stem cell product EQSTEM for the treatment of horses. Positive results from two preclinical studies in horses have shown strong support for the continued development of EQSTEM for osteoarthritis and other degenerative joint diseases in horses. Xintela plans to bring EQSTEM to market in cooperation with partners.
In cancer therapy (which is run by the subsidiary Targinta AB), therapeutic antibodies that specifically bind to the target molecule integrin α10β1, which is expressed on certain aggressive cancer cells, including cancer cells in triple-negative breast cancer and the brain tumor glioblastoma.
Osteoarthritis (OA) is a debilitating and painful joint disease characterized by cartilage and joint degradation and loss of chondrocyte function. It is the most common chronic disease of the joints, mainly in the knee, hip and hand, and the single most common cause of disability in older adults. It is estimated to affect about 25 percent of all individuals over 60 years of age and is on the rise due to an increasing ageing population. Pharmacological treatments offered today only provide symtomatic relief but do not treat the cause of the cartilage degradation.
Difficult-to-heal leg ulcers, including venous leg ulcers, representa major clinical problem, both in terms of suffering and pain for the patient, as well as to healthcare due to the huge financial burden for treatment costs. It is estimated that between 0.18 and 1 percent of the population is affected by venous leg ulcers. The prevalence increases with age and is estimated to 4 percent in individuals above 65 years. Current treatments of difficult-to-heal leg ulcers include compression therapy and surgery, but there are no efficient pharmacological treatments available.
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