Newsletter December 2019
CEO comments
The recent past has been very eventful. Important intermediary goals have been achieved in the development processes of both Rabeximod and T20K. Much is ongoing within the organization and we are in the process of recruiting a new CEO to take Cyxone further into the expansive phase we are facing.
Together with Cyxone’s competent and experienced team and our partners, my mission as acting CEO is to continue to run our projects and activities in accordance with the laid down plan. We are also looking at expanding the team and how best to build the organization for future needs.
The development work with our drug candidates is in full swing. The plan is set for upcoming activities, both for T20K and Rabeximod. Thanks to the shareholders’ support and the good outcome of the warrant of series 3 (TO3), we at Cyxone now have the opportunity to add another gear in the development of our two candidates.
In short, we at Cyxone have an exciting time ahead of us in 2020. The goal for the Board, the team and me is to continue to develop the company, drive the development of our drug candidates and build value.
With that said, I want to take the opportunity to wish you all a Merry Christmas and a Happy New Year!
Malmö, December 23, 2019
Ola Skanung
Acting CEO och CFO
Rabeximod
The development of Rabeximod, our candidate for rheumatoid arthritis, is steadily moving forward. The six-month toxicology study, whose results will form the basis for the forthcoming Phase IIb study in patients, is now underway. Only a few weeks ago, an agreement was signed with a British contract research organization (CRO) for conducting the toxicology study, which marks an important step forward in the development process. The preparation work began immediately with a plan to start the studies immediately thereafter.
Prior to the Phase IIb study in patients, we recently announced that an agreement was entered with the Evotec-company Aptuit for the capsulation of the substance. Aptuit has previous experience of Rabeximod as they manufactured the capsules for the previously completed Phase IIa study. There is a large number of capsules that will be needed as in addition to giving these to patients, continuously before, during and after the study, they need to be checked to ensure that nothing happened to the product during handling and storage. The capsules will also, after manufacture, undergo a series of feasibility studies to ensure quality and patient safety requirements.
Other relevant preparations for the Phase IIb study in the near future include selecting good suppliers of bioassay and central lab. It is very important that the right partner is selected, to ensure effective and high-quality analysis and results of the study. Furthermore, the regulatory requirements are now being reviewed for the countries in which the study will be conducted. These are processes that are highly necessary to conduct with great accuracy to ensure that the set goals, timeframes and quality requirements will be maintained without any anticipated problems.
With these parallel processes in progress, the work towards the Phase IIb study is moving at full speed.
T20K
With regards to the T20K for multiple sclerosis, we have just formally completed the work on the final clinical study report after the Phase I study, which was conducted together with QPS in the Netherlands. A very formal milestone that takes us a regulatory step forward.
Prior to continuing clinical studies, work is currently underway to study alternative oral preparations and the format that will form the basis for a future product. At the same time and depending on the oral formulation, the detailed planning of the Phase I-II studies is ongoing.
International exposure
With Cyxone’s presence in Switzerland, through our wholly owned subsidiary in Basel, we can continuously strengthen our international position through the proximity of international investors and potential partners. It is an exciting context to be in and we at Cyxone look forward to continuing to strengthen our presence in the scientific as well as the business sector.