First North-listed biotech company Cyxone is developing immunomodulatory drugs to treat severe autoimmune diseases. The company has the ambition to meet a widespread medical need and improve patients’ quality of life with effective, safe and gentle treatments. Cyxone’s pipeline includes two clinical projects, Rabeximod for rheumatoid arthritis (RA) and T20K for multiple sclerosis (MS).

Strengthened management team

During the year, Cyxone strengthened its management team with several recruitments. In January, Malin Berthold was appointed Chief Operating Officer (COO) with the task of running the preclinical and clinical development work. Read BioStock’s interview with Malin here (In Swedish).

On June 1st, Tara Heitner joined as Cyxone’s new CEO. Canadian Tara came to the company with an international network and vast experience from the life science sector, both through scientific work and through business development in a number of different companies around the world. Read more about Tara Heitner here.

The recruitment also meant that Ola Skanung was able to return to his role as CFO in the company, after a period as acting CEO.

Much of Cyxone’s work during the spring has been focused on preparing the drug candidates for the next clinical step in their development.

T20K – a gentle and long-term MS treatment

The candidate T20K is developed as a new oral treatment and is aimed at a type of MS that affects a large proportion of MS patients – relapsing remitting MS. The drug candidate is developed to be able to slow down or prevent the progression of the disease, while at the same time causing fewer side effects compared to today’s drugs.

The oral formulation is something that is sought after by many patients as they prefer to take pills or capsules and avoid injections with syringes. During spring, Cyxone initiated studies to investigate how T20K is absorbed and broken down in the gastrointestinal tract to get guidance on how to proceed in selecting an oral formulation and formulation partners. The development of a pill or capsule is also seen as value-enhancing by potential business partners.

Extended patent protection for T20K

In March, the Medical University of Vienna announced that it had submitted an application for an extended patent regarding the technology on which T20K is based. The new application means that Cyxone’s patent protection is extended, both in terms of therapeutic possibilities and the life of the patent.

The Medical University of Vienna is conducting research in this area and has found opportunities for more results that Cyxone can utilize in its future drug development. Although Cyxone does not own the patent, the company has exclusive rights to apply and develop the substances covered by the patent. The company has no commitments to pay licensing fees or royalties on future drug sales, all possible revenue accrues to Cyxone.

The application will be made public in the spring of 2021, but research is ongoing, and it is possible to add data and material until then. Therefore, in order not to limit its possibilities, Cyxone currently declines to comment on the details of the data file sent to the Patent Office.

The patent application also means a new priority date, which in practice means that the original patent has been extended by eight years and is now valid until 2040, which is a significant period of time for a new drug on the market.

Rabeximod towards phase IIb

Cyxone’s most advanced project is the First-in-Class candidate Rabeximod, which is developed for treating RA and is now preparing for a forthcoming phase IIb study. In January, Cyxone decided to order new rabeximod substance to get the best possible conditions for conducting the study, which is scheduled to start in Q1 2021.

The order was scheduled but was placed earlier to avoid delays at a later stage of the process. The preparation of the new substance is underway and will later be formulated into capsules before formal applications for permission to initiate the clinical trial can be submitted to the authorities of the intended study countries. The ethics committees in several of the countries concerned have already given their approval.

Collaboration agreements and new patent applications

Cyxone’s operations are not just limited to the clinical programs. In June, the company announced that it has entered a development agreement with the inventor Kalev Kask to develop a drug for the treatment of symptoms that may occur in Covid-19 patients. Cyxone will own all future intellectual property rights and be responsible for development costs. Kalev Kask, for his part, has the right to call for a directed new issue of Cyxone shares to himself or one of his designated investors, corresponding to a maximum of approximately SEK 21 million. The right to call for the issue is valid until 1 October 2020.

In June, Cyxone also announced that it had applied for four new patents to protect new innovative results. The company was otherwise tacit in connection with the announcement and referred to later communication occasions. As with the T20K application, the company does not want to disclose the confidential data that forms the basis for the patent applications.

Strong share price performance

Although Cyxone’s operations have not been significantly affected by the coronavirus pandemic, the company’s share price has followed the general stock market movements caused by the crisis. Like the rest of the market, the shares hit their low in mid-March, but have steadily risen since then. During the first six months of 2020, the share went up by a total of 49 percent.

With the new management team in place before the end of June, Cyxone is now charging against the rest of the year, with continued preparatory work within the clinical programs and new promising forms of collaboration.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.