Projects making steady progress and Xintela is growing
Projects in both regenerative medicine and oncology are making progress and developing very positively, which has required us to hire more personnel. We are now 18 employees and five consultants in the company, and we expect to recruit additional personal before long. As a result, we have also signed a contract for new premises at Medicon Village. We will be moving Targintas personnel to their own laboratory facilities and, eventually, management will also move to other office premises. This will provide more space for the stem cell operations, which are currently in a very expansive phase.
Sven Kili appointed as COO
We recently announced that Sven Kili will be taking up the role of Chief Operating Officer at Xintela. We are very pleased that Sven Kili now has the opportunity to extend his commitment to Xintela. Sven is a physician and specialist in orthopaedics and, through leading positions in the pharmaceutical companies Genzyme, Sanofi, and GSK, has many years’ experience of successful development and commercialisation of cell and gene therapy products.
We are in a very exciting and active phase, owing to our preparations for GMP production of our stem cell product as well as the start of clinical studies, and Sven’s extensive experience in these fields is extremely valuable. Additionally, his broad international network within cell and gene therapy will make him a key person for Xintela’s financing and internationalisation activities.
GMP production
Activities to get the GMP facility ready for inspection are proceeding as planned. The premises and instruments are qualified and currently in use. The quality control system is in place, and the final adjustments are being made to methods, documentation and working procedures. We will have an industry dialogue meeting with the Swedish Medical Products Agency (MPA) in May, and will subsequently plan for an inspection.
Clinical trial
Xintela is now approaching the start of the first clinical trial with XSTEM-OA, Xintela’s product candidate consisting of stem cells selected with Xintela’s marker technology XINMARK® The plan is to conduct the study in Australia and a partner, in the form of a local Australian clinical research organisation (CRO), has been identified. The study design has been discussed with external clinical advisers and the protocol is in the final phase of completion. When we have a manufacturing licence from the MPA, we will know when we can start the first-in-human trial in Australia. In consultation with the MPA, we have decided to submit a production application after the summer.
Discussions with CO.DON regarding eventual collaboration are ongoing until 30 June, according to the extension of our Letter of Intent. A collaboration will start, at the earliest, after the conclusion of our clinical trial in Australia.
Stem cell therapy for animals
When it comes to developing stem cell therapy for animals, Xintela’s strategy, as reported previously, is to conduct R&D in collaboration with one or several veterinary medicine companies. There is significant interest in stem cell therapy from these companies, not least for the treatment of osteoarthritis in dogs, which is a large and attractive market. Reports show that every fifth dog suffers from osteoarthritis by the age of two, and there is a significant need for an effective treatment.
We have decided to postpone the planned preclinical horse study because it is not necessary for starting the clinical trials in Australia, and we are instead focusing entirely on preparations for the clinical trial of our human stem cell product XSTEM-OA. When we have a collaboration agreement in place with a partner within veterinary medicine, we will focus more on stem cell therapy for horses and/or dogs.
The oncology project
A lot is happening in the Targinta project. Work is fully underway with the antibody-drug conjugates (ADCs) from the collaboration with Catalent and we are evaluating them in different cell experiments. The goal is to identify the best candidate for in vivo studies. We are also evaluating other ADC technologies so we can compare results and decide which ADC technology will work best on our target (integrin 10) and with our antibodies. Our initial focus is on the treatment of glioblastoma, but we have also worked intensively on evaluating other forms of cancer. The research has been very successful, leading us to submit a patent application that will extend the protection of cancer diagnostics and therapy for addition forms of cancer based on our marker technology. The new application sets a broad foundation for the continued development of the oncology business in Targinta.
Targinta
Targinta is currently a wholly-owned Xintela subsidiary and is formally prepared for spin-out. As we have previously announced, we will wait with the spin-out until we have secured financing for Targinta. For the time being, we are evaluating different financing solutions and meeting potential investors while we continue to build value in Targinta through important progress in the oncology projects. We are focused on equipping Targinta with a strong and attractive research foundation in order to demonstrate the company’s significant potential prior to financing. Results from the glioblastoma project that have now been submitted for publication, as well as the results from other cancer forms that lay the groundwork for the new patent application, are important elements in this work. When we are ready to implement the spin-out, we will make an announcement to this effect in a timely manner.
Conferences and investor meetings
We have been very active in terms of our participation in various relevant conferences, including partner and investor meetings, to continue to build our international network of potential partners. Among other conferences, we have participated in LSX Investor World Congress in London, Animal Health Investment USA in Boston and will participate in BIO International Convention in Philadelphia in June. Interest in Xintela’s projects is strong in both human and veterinary medicine. During March and April, we participated in conferences in Germany and Sweden, where we were invited to present Xintela’s stem cell business; we have also been invited to present at a Danish stem cell conference in May. It is gratifying that we are receiving so much attention for our stem cell technology and GMP facility, and that we are considered a significant player in the field of cell therapy.
The collaboration with our new major shareholder Bauerfeind is proceeding very well. We are having ongoing discussions about new possibilities and areas where our companies can deepen our collaboration going forward.
In conclusion, we would also like to welcome you to the Annual General Meeting on May 27 in Lund.
