This newsletter was released in Swedish on the 12th of July
The beautiful summer has also arrived at Xintela and our employees are now looking forward to a well-deserved break. The summer also gives me more time to think about how Xintela’s various projects have moved forward since the start and about everything exciting lying ahead of us. We started our activities and began employing staff in 2013, which is when our stem cell research really picked up. A few years later, the oncology business gained momentum when our marker was discovered on glioblastoma cells. However, the company was actually founded in 2009 and that is why we are celebrating our 10th anniversary this year. I feel extremely proud as I look back at what we have delivered over the years – and yet this is just the beginning. In this newsletter, I will provide a brief look back, and describe how our projects have developed and where we are now.
XINMARK® and XACT™
Xintela’s operations are built on the company’s XINMARK® technology platform, which is based on certain cell surface proteins, integrins. My research team discovered Integrin α10β1 on chondrocytes more than 20 years ago. The knowledge of integrins and chondrocytes, and the tools we have developed over the years, led to the XACT analytical test™ for quality assurance ofchondrocytes, and to our collaborations with both German CO.DON and Japanese CellSeed. These collaborations have been very positive and led to our further development of XACT and a new patent application about two years ago. Due to the new patent application and the unique position it has given us, we are now considering the development of chondrocyte-based products both in-house and through potential partnerships.
The stem cell project
Over the years, Xintela’s stem cell project has made fantastic progress and the solid research behind our R&D receives very positive response. Our marker technology, which has given us unique opportunities to identify, select and quality-assure stem cells, is enabling us to meet the functional, qualitative and regulatory requirements of a cell therapy product. Although our primary focus is osteoarthritis therapy, we are also evaluating other indications in both orthopaedics and the centralnervous system (CNS). In preclinical studies on horses, we have shown that stem cells produced with our technology are both safe and have protective effects on both cartilage and bone following cartilage damage. In collaboration with Lisa Fortier and her research team who led the horse study, we have continued to study the stem cell mechanisms that may be involved in the positive study outcome. Some of these results were recently presented at two international conferences, the ORS Annual Meeting (Orthopaedic Research Society) in Austin, Texas and the OARSI World Congress (Osteoarthritis Research Society International) in Toronto, Canada. The results provide information about the molecular mechanisms involved in the stem cells’ effect and further support for the use of our stem cells in osteoarthritis therapy. We have also initiated a collaboration with Associate Professor Casper Lindegaard at Copenhagen University to increase knowledge about the mechanisms of action of our stem cells when they are injected into a joint to treat the degenerative joint disease osteoarthritis.
Clinical trial
We are now approaching our first major goal for the stem cells, to start up a clinical trial on patients with osteoarthritis. The clinical trial protocol is in place and a CRO as well as clinics where the studies will be carried out have been identified. We will be having a scientific advice meeting with the Swedish Medical Products Agency at the end of September for advice on our production of stem cells and the design of our first-in-human trial. We will also be holding a meeting with our Clinical Advisory Board in October, comprising international clinical experts in the field of osteoarthritis, to discuss the clinical trial plan.
GMP production
Alongside of planning the clinical trial, we are also working to become GMP-compliant (Good Manufacturing Process) for production of XSTEM-OA, our stem cell product for the treatment of osteoarthritis. In May, we engaged in dialogue with the Swedish Medical Products Agency for advice related to process validation prior to the submission of our manufacturing license application. The meeting was very informative and rewarding and gave us suggestions for some changes to our validation process before submitting our application. This will delay our application by a few months but facilitates the subsequent approval process.
Over the past two years, we have invested heavily in our business by the establishment of our own GMP facility. This investment is very important for Xintela because it gives us flexibility and total control over the production of our cell therapy products as well as major benefits in terms of economics and time. In addition, a GMP facility significantly increases the value of our cell therapy projects because we can offer our partners both high-quality stem cell products and important production capacity. Our efforts have received a very positive response, especially from veterinary medicine companies.
Collaboration with Bauerfeind
It is gratifying that the collaboration with our principal owner Bauerfeind AG is making excellent progress. We are having ongoing discussions about new possibilities and areas where our companies can deepen our collaboration moving forward.
Although our letter of intent expired on 30 June, our collaboration discussions with CO.DON have continued.
The oncology project
The important discovery that we made a few years ago, that our integrin α10β1 marker is expressed by cancer cells in the highly aggressive glioblastoma tumour, marked the beginning of an exciting oncology project that has evolved beyond expectations. We have presented positive preclinical data both in vitro and in vivo showing that an antibody treatment can kill glioblastoma cells, and also published the findings in a prestigious scientific journal. These positive results also led to our evaluation of other aggressive cancers with attractive markets, such as breast cancer, prostate cancer, lung cancer and pancreatic cancer, and we have submitted a new patent application to protect a broader use of our marker technology in oncology. Over the next six months, we will be conducting preclinical studies on cells and in animal models to study possible therapeutic antibodies. Some of these antibodies will come from our collaboration with the US company Catalent. We have previously decided that the oncology business will be conducted in our subsidiary Targinta and that we will complete a spin-out of Targinta when financing has been secured.
The Board welcomes Peter Edman
I would like to take this opportunity to welcome Peter Edman to our Board. Peter has been working for Xintela as a consultant for some years and it is very gratifying that the Board will now be able to benefit from his drug development experience. Peter Edman will replace Claes Post who has been a Board member since 2013 but now decided to move on. Claes has been a great asset to Xintela and I would like to thank him for all of his great work on the Board.
Finally, I would like to wish all of our owners an enjoyable summer.
Evy Lundgren-Åkerlund, CEO of Xintela.
