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.
Xintela is conducting a clinical study (Phase I/IIa) with XSTEM in Australia, in patients with moderate knee osteoarthritis (Kellgren-Lawrence grade II-III). Three different dose levels of XSTEM are being evaluated in up to 54 patients and each patient is followed for at least 18 months (the patients on the highest dose level are evaluated for 24 months) with continuous safety evaluation and preliminary efficacy reading every six months. XSTEM have been dosed at all dose levels in a total of 24 patients and all dose levels have been judged safe by the study's Safety Review Committee after three months. All patients at the lowest dose level have completed the study 18 months after treatment. Xintela has the opportunity to expand the study with an additional 30 patients. The primary goal of the study is to show that XSTEM is safe, but also to obtain preliminary efficacy results that show that the product has DMOAD (Disease Modifying Osteoarthritis Drug) properties and can slow down cartilage and joint degradation as well as restore damaged articular cartilage and improve joint function. Xintela's earlier results from preclinical osteoarthritis models, support the possibility that XSTEM may have a positive disease-modifying effect.
Read more about osteoarthritis below.
Xintela's second clinical study (Phase I/IIa), in patients with difficult-to-heal venous leg ulcers, is being conducted in Sweden. Twelve patients with difficult-to-heal venous leg ulcers will be treated with XSTEM or placebo applied to the wound and are then be followed weekly for ten weeks as well at four months after treatment. The primary goal of the study is to show that the treatment is safe but also to evaluate wound healing efficacy. The first patient has completed the study and additional patients have been dosed. Recruitment and screening of patients is ongoing.
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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