Newsletter

Newsletter November 2016

Jan 9, 2017

Message from the CEO
I am really pleased with the number of people who show an interest in Cyxone, what we are doing, and the progress of T20K. A lot of people communicate with me, and although I try to answer all the queries that come in as best I can I have been busy recently. During the fall, I have had to focus on setting up contracts with companies around the world to facilitate our various studies, as you can see from the goals outlined in the prospectus that we published earlier.

The goals outlined in the prospectus:

  • Optimize chemical synthesis
  • Verify effects in Multiple Sclerosis animal model
  • Measure effects with respect to in vitro pharmacology and ADME/tox
  • Characterize T20k’s properties before creating an oral formulation
  • Develop bioassays
  • Pharmacokinetic and metabolism studies
  • Acute dose-escalation study in animals to find tolerated dose
  • Measure general pharmacological effects
  • Studies in Multiple Sclerosis animal model with today’s established drugs
  • “Scientific advice” from the Swedish Medical Products Agency and the regulatory plan
  • Introduce T20K to potential licensing partners

So, I need to find a more efficient way to keep you all informed. Because of this I have decided that in the future a monthly newsletter will be published around the end of each month. This will be used to communicate public information about our ongoing activities at Cyxone and enable you to follow the development process of T20K. Information that is potentially “share price sensitive” will continue to be communicated through press releases in a more formal way.

I believe that this monthly newsletter will fulfill the need for information. It will enable me to comment on the suggestions that I enjoy getting and hold an active dialogue which of course will help drive the future development of T20K.

The development progress of T20K
In conclusion, all activities are progressing to plan apart from the advice from the Swedish Medical Products Agency, which can only be implemented after we have received the final reports from key studies. It may be worth mentioning that each activity is being carried out in a stepwise manner, this means that we can learn from the results at each stage and work as efficiently as possible, as well as minimizing the number of laboratory animals used. In this way, we are in line with the big pharmaceutical companies.

Comments on individual activities
Manufacturing and formulation
The method of synthesizing T20K, Cyxone’s cyclic peptide, has now been developed by a reputable international company in Switzerland, and we are working to determine the appropriate salt form before the regulatory studies. We are expecting a delivery of T20K during November and we anticipate that this will last for most of the preclinical studies.

T20K’s properties as a drug candidate are being investigated by a company in Denmark that specializes in pre-formulation and have experience of peptide drugs. The goal is to create the optimal oral formulation of T20K.

Preclinical studies
A preliminary study on mouse MS (EAE) has been performed with T20K by an American laboratory but because the technology used by them turned out to be incompatible with T20K another laboratory in Australia has been selected to perform the mouse EAE study. This study will use a leading oral drug as a comparison.

We have identified a number of relevant in vitro pharmacological tests and companies that can explore the effects of T20K. These studies are expected to be completed in Q4/16.

Studies to further determine the maximum tolerated dose of T20K in animals are ongoing. The first study showed that T20K did not cause toxicity at doses at least 25 times higher than the effective dose for the symptoms of MS. The General Pharmacological effects of T20K are regularly assessed in all animal testing to provide an overall picture of the effect on the animals’ condition.

Methods for analyzing T20K in biological material have been developed by an experienced Austrian laboratory, and are now used to identify T20K in samples collected after oral and intravenous treatment of animals with T20K.

Activities with pharmaceutical companies and government agencies
During the fall Cyxone presented T20K and its effects on MS to a number of pharmaceutical companies with an interest in autoimmune diseases. Cyxone will meet new pharmaceutical companies to introduce T20K and cyclotides and provide updates on the development status to the companies previously encountered.

Cyxone will meet the regulatory body as soon as final reports are available from key studies of T20K.

In September, a milestone was reached for Cyxone, when the US Patent Office approved the patent application on cyclotides and T20K. Through this approval, T20K has been endorsed as a potential “first in class” drug in the largest pharmaceutical market in the world.

Meetings during October
During the past month, Cyxone has been invited to the following meetings:

  • Bio Spain, a partnering meeting in Spain where companies meet in 30-minute sessions to determine whether there is a basis for cooperation, partnerships or licenses.
  • Clinical Trial Excellence Forum in Germany, a closed-door event where the latest in early clinical studies was discussed.
  • Drug Discovery Innovation Program in Germany, where front-line procedures to identify new drug candidates were presented.

Upcoming meetings and new website
Between the 7th and 9th of November Cyxone will participate in BioEurope in Cologne, where we will meet other drug companies to present T20K and its effects on MS.

Cyxone is continuing to work with the website to simplify communication with shareholders and all others interested in the company. The company plans to launch the new website in about a month.

New and existing shareholders who would like to hear directly about Cyxone’s latest result and plans will have the opportunity as I will be presenting present at the meetings below:
– Stora Aktiespardagen in Stockholm on the 28 November
– Aktiespararnas Investerarträff in Lund on the 31 January 2017.

Malmö on the 8 November 2016
Kjell G Stenberg
CEO