Xintela signs agreement with Region Östergötland for GMP process development of cell therapy for burn patients

Xintela and Region Östergötland have signed an agreement where Xintela will develop and establish a GMP process to isolate and quality assure autologous (patient-own) skin cells for the treatment of burns. The agreement is worth SEK 3.6 million. The process will form the basis for an approval from the Medical Products Agency for the Burn Centre, Linköping University Hospital, to start a clinical study on burn patients. In the next step, Xintela will manufacture skin cell preparations from patient biopsies in Xintela’s GMP-approved production facility under a further agreement with Region Östergötland.

“It is very positive that we are now broadening the use of our GMP facility and our expertise to process development and production of other advanced drugs, so-called ATMPs (Advanced Therapy Medicinal Products). In the collaboration with Region Östergötland, we will use our experience in manufacturing ATMPs, to provide cell-based investigational drugs for clinical studies for an external customer, which brings revenues to Xintela. The availability of approved GMP facilities for ATMP manufacturing in Sweden is very low and it feels extra important that we can contribute to the supply of investigational drugs to patients where the medical need is very high”, says Liselotte Theorell, Xintela Director Quality Management, QP.

“Region Östergötland and the Burn Center, Linköping University Hospital are very positive about a collaboration with Xintela and look forward to seeing the first Swedish ATMP (cell-based) product for the treatment of severe burns as a result of this collaboration. This can be a major step forward for the development of new treatment methods in the field of burn care and regenerative medicine in Sweden”, says Consultant and Associate professor Moustafa Elmasry, Head of Research and Development Unit for skin and cultured cells, Department of Hand and Plastic surgery, Linköping University Hospital.

Contacts

Xintela AB (publ)
Evy Lundgren-Åkerlund, CEO
Tel: +46 46 275 65 00
Email: evy@xintela.se
Medicon Village
223 81 Lund, Sweden
www.xintela.se

This information is information that Xintela AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-08-29 19:33 CEST.

About Xintela

Xintela develops medical products in stem cell therapy and targeted cancer therapy based on the Company’s cell surface marker integrin α10β1 which is found on mesenchymal stem cells and on certain aggressive cancer cells. The stem cell marker is used to select and quality-assure the patent-protected stem cell product XSTEM®, which is in clinical development for treatment of knee osteoarthritis and difficult-to-heal leg ulcers. The company produces XSTEM for the clinical studies in its GMP-approved manufacturing facility. In cancer therapy, which is run by the wholly owned subsidiary Targinta AB, therapeutic antibodies, targeting integrin α10β1 (First-in-Class) are being developed for the treatment of triple-negative breast cancer and the brain tumor glioblastoma. Xintela conducts its business at Medicon Village in Lund, Sweden, and is listed on Nasdaq First North Growth Market Stockholm since 22 March 2016. Xintela’s Certified Adviser is Carnegie Investment Bank AB (publ).

Links