Closer to clinical trials
We are now closing in on our next major milestone: initiating clinical trials with the stem cell product XSTEM. Many pieces of the puzzle have fallen into place for us to get this far, each of which reflects a great deal of hard, goal-oriented work by our team.
Some of these important puzzle pieces include an approved GMP procedure for producing our stem cell product XSTEM, an approved GMP facility and a product patent that protects XSTEM for all use going forward. We have also expanded our production team to ensure we have full capacity for producing XSTEM for clinical trials. Each step we have taken in our development work has confirmed that we are on the right path.
As a result of the GMP approval from the Swedish Medical Products Agency, our efforts are now fully geared toward the production of XSTEM for our first clinical trial in Australia on patients with osteoarthritis of the knee. One reason for choosing Australia for the trial is the outstanding stem cell research being carried out there, which has led to experience in stem cell-based clinical trials among both government agencies and clinics. We have now initiated a partnership and signed contracts with GreenLight Clinical (GLC), our clinical partner in Australia, to conduct the clinical trial.
We have been working with GLC on regulatory issues and the compilation of clinical documents for several years, and are confident that we have a good partner in GLC for conducting this clinical trial. We also recently formed an Australian subsidiary, Xindu, which will manage the formalities related to the trial. We can obtain advantageous tax incentive for our development costs in Australia through Xindu, which is an important reason behind our formation of the subsidiary.
In the clinical trial on osteoarthritis patients, the main goal is to demonstrate the safety of our product. We also hope to obtain preliminary findings that show that XSTEM has the properties of a disease-modifying osteoarthritis drug (DMOAD), meaning it can prevent the further breakdown of cartilage in osteoarthritis patients and promote the regeneration of damaged cartilage, thereby improving joint function. At present, there are no DMOADs in the market, and the market potential is therefore significant. In partnership with Copenhagen University, we recently demonstrated in a preclinical model that our stem cell product XSTEM, when injected into a joint with cartilage damage, targets the damage and can be converted into cartilage-like cells that produce new cartilage tissue. This indicates that XSTEM has regenerative properties and thus has great potential to function as a DMOAD in the treatment of osteoarthritis.
We are also planning for other clinical trials going forward. Our strategy is to focus on diseases that currently lack effective treatments. One example is chronic wounds that are difficult to heal. The medical need is significant, and it is estimated that wound care represents 3–4% of all health care costs. In collaboration with Professor Folke Sjöberg and his team at the Burn Injury Centre at Linköping University Hospital, we have shown in a preclinical model that XSTEM has a clear wound-healing effect and that the newly formed dermal tissue resembles normal skin. This area is very interesting, since the clinical trials run for a relatively short time and we can quickly get to market with a wound-care product.
Several key pieces of the puzzle in our oncology project have also fallen into place, which has led to our assessment that the project and our subsidiary Targinta are now ready to be spun off.
Our decision that this is the right time for a spin-off was based on the extensive preclinical findings we have obtained with our therapeutic antibodies that significantly reduce tumour growth of both glioblastoma and triple-negative breast cancer in validated animal models. The findings from cell studies, animal models and tumour tissues all point in the same direction: our targeted and therapeutic antibodies, directed against the target molecule integrin α10β1, have great potential for development into a new, effective treatment strategy for aggressive cancer. This provides a firm foundation for Targinta to build further upon. The medical need is significant, and Targinta can make an important contribution for patients who suffer from aggressive cancers that are difficult to treat.
With the recruitment of Per Norlén as CEO of Targinta, we have created the best conditions for a spun-off company to develop and commercialize its projects. With his previous experience from developing antibody-based drugs for the treatment of cancer, Per is truly the right person to lead and develop Targinta’s projects onward toward clinical trials and to establish strategic partnerships. I look forward to passing the torch to Per on 1 September.
I would also like to call your attention to the analysis of Xintela that was recently published by the London-based investment research firm Edison Group. The analysis describes Xintela’s and Targinta’s projects and their tremendous market potential. You can read the analysis here.
Finally, I would like to wish you all a continued pleasant summer!
Evy Lundgren-Åkerlund
CEO, Xintela AB (publ)
