Tis 9 aug / År 40 / Nr 3 2022

Stem cell product XSTEM in clinical studies

The Swedish biopharma company Xintela is receiving a lot of attention for its stem cell product platform XSTEMÒ and its stem cell therapies in development. XSTEM is now in clinical development for the treatment of knee osteoarthritis and difficult-to-heal venous leg ulcers.

CEO Evy Lundgren-Åkerlund

Over the last several years Xintela has worked extensively on preclinical development in three core areas: osteoarthritis, difficult-to-heal leg ulcers and ARDS (Acute respiratory distress syndrome). The company has now entered into clinical development with its patented stem cell product XSTEM which consists of integrin a10b1-selected mesenchymal stem cells from donated adipose tissue.

Clinical development in knee osteoarthritis and difficult-to-heal venous leg ulcers

Xintela has started its first clinical study (Phase I/IIa) in Australia in patients with knee osteoarthritis. The main goal 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 regenerate damaged articular cartilage and improve joint function.

A clinical study with XSTEM in patients with difficult-to-heal venous leg ulcers (Phase I/IIa) is scheduled to start after the summer. The study will be conducted in collaboration with Linköping University Hospital in Sweden and is largely financed by grants from Vinnova.

Preclinical studies have shown that XSTEM is both safe and effective and has the ability to regenerate damaged cartilage and skin wounds in relevant animal models. Today, there are no treatments available that can regenerate and heal Difficult-to-heal leg ulcers or damaged cartilage in osteoarthritis. XSTEM thus holds great potential to be a breakthrough in the treatment of these diseases.

“What is unique about our patented stem cell product XSTEM is our stem cell selection technology that allows for the generation of a homogenous and high-quality product which likely improves both safety and efficacy compared to other stem cell technologies. The stem cell selection step also assures reproducibility between different stem cell preparations, which is a great regulatory advantage”, says CEO Evy Lundgren-Åkerlund.

XSTEM has also been evaluated in a preclinical model for ARDS; a life-threatening form of acute lung failure, which can occur as a result of, for example, blood poisoning and pneumonia and can also affect seriously ill Covid-19 patients. The studies which were performed in collaboration with Skåne University hospital and Lund University

showed significant therapeutic effect of XSTEM including less lung tissue damage and improved lung function.

“There is no treatment available for this terrible lung complication and the mortality is very high. We are therefore very excited about the promising therapeutic effect of XSTEM in the  preclinical ARDS model and we are now looking for a partner to take the step towards clinical studies with XSTEM to treat ARDS patients” says Evy Lundgren-Åkerlund.

Manufacturer of ATMPs

Last year, Xintela received permission from the Medical Products Agency to manufacture XSTEM and other advanced therapies in the company’s own GMP-facility. The manufacturing facility is fully operational and the team has successfully produced XSTEM for the clinical studies of both osteoarthritis and difficult-to-heal leg ulcers.

“It was an important strategic decision to build our own GMP-facility to manufacture our stem cell products in-house. This gives us full control of the product development, full flexibility and a highly cost-effective production solution”, continues Evy Lundgren-Åkerlund.

For Xintela, their stem cell product XSTEM and GMP-facility are paving the way for more opportunities not just for them, but for many partners within the wider medical community.

“Our patented and highly competitive stem cell product XSTEM, combined with our own GMP manufacturing capability, is an attractive concept in partnering discussions. Our GMP-manufacturing competence also opens up the possibility to act as contract manufacturer to support process development and manufacturing of other ATMPs, by which new revenue opportunities can be created”, concludes Evy Lundgren-Åkerlund.