Newsletter December 2019
Progress on several fronts during the year
2019 was an intensive and successful year for our projects in stem cell therapy and oncology and it is now exhilarating to look back over all the progress made by the company. The following newsletter summarises how Xintela’s operations have changed during the year and outlines our overall plans for the coming year.
All steps in the process for GMP stem cell manufacturing are in place
We have now worked through all of the critical steps in the process from isolating stem cells from adipose tissues to selection, expansion and formulation of stem cells under strict GMP conditions. In the selection step, we have manufactured a new antibody that will act as our main tool in the production of our stem cell product and that meets the requirements of authorities in terms of safety, quality and documentation. The production of the antibody was carried out in cooperation with BioInvent in Lund, which has extensive experience of antibody production for clinical use. One important milestone for GMP production was the signing of a contract with the clinic that supplies donated fat tissue for our stem cell manufacturing, which ensures the delivery of the tissue in line with the set criteria including patient safety.
In May, we engaged in dialogue with the Swedish Medical Products Agency for guidance on process validation prior to the submission of our manufacturing license application. The meeting was very informative and rewarding and gave us guidance on some changes to the validation process that will facilitate the approval process. In the New Year, we will produce technical production batches to establish that our process complies with the EMA and Swedish Medical Products Agency’s extensive requirements prior to the submission of our manufacturing license application. The Agency will subsequently carry out an inspection followed by approval to begin production for clinical trials.
Preparation of clinical trials in Australia
In September, a scientific advisory meeting was held with the Swedish Medical Products Agency to solicit their feedback on the production of our first stem cell product XSTEM-OA and on the design and approach used in our First-In-Human study. We received a highly positive response and confirmation that we have a clear and good plan looking ahead. Our first clinical trial will be conducted in Australia and be a Phase I/IIa dose study where we are assessing the safety and preliminary efficacy of XSTEM-OA on patients with osteoarthritis of the knee. There are several advantages in this, as the authorities in Australia have substantial experience of clinical trials with stem cells and the cost of the studies will be lower in Australia compared with Europe, whilst being well aligned with the EU and US from a regulatory perspective. We will carry out the study ourselves and are planning thereafter to look for a business partner for continued clinical development and commercialization in the EU, US and other geographies.
Xintela’s stem cells, isolated using our selection technology, represent a stem cell platform referred to as XSTEM. We will use the stem cell platform in the treatment of other indications in the future and have already begun to evaluate the next musculoskeletal indication that we will target.
New advances in the oncology project
Recently, we announced the positive preclinical findings from the glioblastoma project, which is an important achievement for the oncology project and our Targinta subsidiary.
We are evaluating two parallel strategies in our efforts to develop a targeting antibody-based treatment for the aggressive glioblastoma brain tumour: one where the company uses Antibody-Drug Conjugates (ADCs), whereby a toxin is linked to the antibodies, and another using antibodies that have their own function-blocking effect. We previously reported that an ADC that binds to integrin α10β1 on glioblastoma cells has a killing effect both in cell studies and in an animal model and the findings were published in April in the journal Cancers (2019, 11, 587). We have now developed function-blocking antibodies that bind to integrin α10β1 and that inhibit the function of glioblastoma cells including migration and significantly reduces the growth of glioblastoma tumours in an animal model. These positive results further validate our patent-protected target molecule integrin α10β1 for the treatment of high-grade gliomas, including glioblastoma. Moreover, we have identified an antibody with the potential to develop into a product for the treatment of glioblastoma and even other aggressive cancers.
Our new results are a real breakthrough for our target molecule and antibody technology and during the next year we will broaden operations and evaluate our antibodies in pre-clinical models for a number of different forms of cancer. These results strengthen our standing in work to attract investors and business partners for the continued development and commercialisation of Targinta’s projects. It also brings us closer to a spin-out of Targinta, which we have announced can take place when financing of the oncology business has been secured.
New patent application for the treatment of aggressive forms of cancer
We have a highly active patent strategy to protect our technology and upcoming products. As part of the oncology project, we have previously filed a patent application that covers the use of integrin α10 antibodies in the treatment of CNS tumours, including glioblastoma, that is now being processed at national level in our targeted countries. In April of this year, we announced a new patent application for antibody treatment of other aggressive cancers, such as breast cancer, prostate cancer, lung cancer and pancreatic cancer.
Work to secure various financing solutions
We are actively working on securing different forms of financing, including project financing through collaborations and grants such as EU programmes. At the end of October, we received a bridge loan of approximately MSEK 8 from our principal owner Bauerfeind Group at an annual interest rate of 3%. The loan will be converted to shares before the end of the year at a rate of SEK 6 per share. The loan offers us an opportunity to continue work to achieve long-term financing arrangements and to evaluate new possibilities and areas in which our companies can deepen our collaboration moving forward. We also have ongoing discussions with major Animal Health companies on possible collaborations for stem cell therapy of OA in animals.
Strengthening the team and expanding in new premises
During the year, we expanded our team by recruiting two individuals for GMP production and another individual to the oncology project. At the beginning of the year, we were presented with an opportunity to deepen Sven Kili’s commitment to the company by combining the roles of Chief Medical Officer (CMO) and Chief Operations Officer (COO) on a half-time basis. During the spring, we were also offered an opportunity to strengthen the Board through the addition of Peter Edman who, with his extensive experience of drug development and business strategy, is a great asset to the company.
Tomas Areschoug left his position as business developer in November. We are very grateful to Thomas for his contribution to Xintela and wish him every success in his future endeavours. A new business developer will be employed in the near future.
The need for new premises has grown in pace with the major steps forward taken by Xintela’s stem cell projects and the GMP production unit. In order to offer additional space to the expanding stem cell team, Xintela’s management and Targinta’s personnel have moved to new office and laboratory space at Medicon Village. We are now in an excellent position to meet future key milestones and look forward to a new intensive and exhilarating year.
Xintela and Targinta wish you a Merry Christmas and a Happy New Year.
