Dear shareholders,
Xintela is targeting several important milestones in the remainder of 2020 and 2021, which are the result of years of strategic, goal-oriented efforts in stem-cell and cancer treatment projects. In the summary below, I present updates on the status of Xintela’s projects and of the company’s strategy and future milestones, in both the near future and longer term.
Through its XINMARK® marker technology and its validated method of selecting stem cells, Xintela has developed the XSTEM® stem cell platform that will be used going forward for the treatment of several different diseases that currently lack effective therapeutic alternatives. The first focus is the treatment of the degenerative joint disease osteoarthritis, with the goal of stopping the degradation of joint cartilage as well as stimulating a repair and improving joint function. In 2021, we plan to begin a Phase I/IIa clinical trial with the XSTEM-OA stem cell product on patients with osteoarthritis of the knee.
Previously, we patented the method of selecting stem cells using our marker technology. On 29 October 2020, we had the privilege of announcing that we had obtained an Intention to Grant decision from the European Patent Office for our XSTEM stem cell product, which protects the use of XSTEM for various treatments including osteoarthritis and other degenerative joint diseases. Our patents ensure development and commercialisation of treatments from our stem cell platform for many years to come.
A new potential indication for XSTEM is Acute Respiratory Distress Syndrome (ARDS), a life-threatening lung complication that could affect patients who are severely ill with COVID-19 and other severe systemic disorders. In an ongoing preclinical trial that we are conducting in partnership with the cardiothoracic surgery clinic at Skåne University Hospital in Lund, Sweden, we are evaluating XSTEM-ARDS in a well-established ARDS pig model. In a press release on 26 October 2020, we announced promising findings in the ongoing study. The findings to date show that the animals treated with XSTEM-ARDS had significantly improved lung function, and that the stem cells could reverse the critical ARDS condition. The next step will be evaluating XSTEM-ARDS in patients, including severely ill COVID-19 patients.
We are also using our stem cell technology to develop stem cell products in veterinary medicine for the treatment of horses (EQSTEM™) and dogs (CANISTEM™). Our strategy is to develop and commercialise stem cell products for animals using dedicated partnerships where Xintela also produces the stem cells.
One important milestone is the construction of our own GMP (Good Manufacturing Practices) facility to produce our stem cell products in-house. The GMP facility, with its specialised instruments for selecting, expanding and formulating our stem cells is now finished and has been in use for some time. Recently, we have been focusing on the XSTEM production process and on the extremely comprehensive validation and quality program. The Swedish Medical Products Agency will shortly be inspecting the facility, the production process and the XSTEM product to determine whether they all meet existing regulatory requirements for GMP. On 28 October 2020, we announced that we had applied for a license from the Agency to operate a tissue establishment, which concerns processing of tissues and cells to be used in the manufacture of medical products. We are following our plan to submit an application to the Swedish Medical Products Agency for a manufacturing license in Q4 2020 and we expect an inspection in the beginning of next year.
A few years ago, we discovered that our marker/target molecule integrin α10β1 was found on cancer cells in certain aggressive malignant forms of cancer such as glioblastoma brain tumours and triple-negative breast cancer (TNBC). We have now successfully evaluated our antibodies that target integrin α10β1 and demonstrated that they significantly reduce tumour growth of both glioblastoma and TNBC in animal models. In ongoing studies, we are also evaluating the effect of the antibodies on other aggressive forms of cancer. In the next step, we will produce selected antibody candidates and conduct bioanalyses and toxicological studies to prepare the antibody for clinical trials. The strategy is to build a strong preclinical package, thereby increasing the value and attractiveness of the project prior to partnerships for clinical development and commercialisation.
The European Patent Office (EPO) recently granted our patent protecting the treatment of glioblastoma and other brain tumours with antibodies that are directed against our target molecule, through 2038. We have also applied for patents for the treatment of other aggressive forms of cancer using our antibodies. Our patent portfolio ensures protected development and commercialisation of our targeting therapeutic antibodies for cancer treatments.
Our success in the oncology projects being conducted by Xintela’s wholly-owned subsidiary Targinta has paved the way for future development towards clinical trials and for partnership discussions. We have firm plans to spin off Targinta in order to give the projects the best conditions for development. Together with financial advisers, we are evaluating various possibilities for financing an independent Targinta; this could be listing on the stock market, private financing or partnerships. At the same time, we are preparing Targinta for spin-off through measures that include identifying a new Board of Directors and management team. The objective is for Targinta to become an independent, self-financing company in 2021.
With important advances in its projects and major patent successes, Xintela is well equipped for future clinical trials, partnerships and commercialisation of its innovative treatments in 2021 and beyond.
Sincerely,
Evy Lundgren-Åkerlund, CEO
