After identifying new therapeutic treatment possibilities for T20K, Cyxone has announced a research collaboration with the Medical University of Vienna to further validate these findings and to deepen the understanding of T20K’s mode of action. The aim of the of the project is to prepare for a clinical phase I study with the new administration form. BioStock reached out to COO Carl-Magnus Högerkorp and non-clinical project manager Sally Abdelmoaty for a comment.
Recently, Malmö-based company Cyxone announced the next development steps for its drug candidate T20K in the treatment of multiple sclerosis (MS). While continuing to develop its oral formulation these plans now include investigating an alternate subcutaneous (subQ) administration route, a biomarker program to support both administration routes and large-scale production of T20K in partnership with a contract manufacturing organisation (CMO).
As CEO Tara Heitner explained in a press release from May,
»The initiation of studies in alternative administration forms and biomarker development for T20K will serve to de-risk drug development and help support transition to clinical studies.«
Collaboration for exploring broader T20K potential
Cyxone recently announced that it has begun a research collaboration with the Medical University of Vienna (MUV), the institution from which the T20K compound was licensed, and where Cyxone still has close links with Professor Christian Gruber, the inventor of T20K. The collaboration includes not only Professor Gruber but also Professor Gernot Schabbauer, specialized in the understanding of immunomodulation of the innate immune system and its role in MS.
T20K is a peptide drug candidate with first in class potential that has shown efficacy in preclinical models of MS. This positions T20K as a possible therapy for early intervention in MS which could potentially address a high unmet medical need and improve the quality of life for MS patients by delaying or even stopping the diseases progression. The new collaboration with MUV seeks to understand if there is additional therapeutic effect which can be a benefit in other subsets of MS patients such as in more advanced stages of MS. The project is part of the ongoing preclinical development activities for T20K, and the studies are important to prepare to go into clinical phase I with the new administration form and the study is scheduled to begin later this month.
Another aim of the collaboration is to confirm the results from previously performed in vivo studies with T20K. A new study design is applied with the purpose of gaining more in-depth knowledge of the T20K’s MoA, and how T20K works in the body.
Professor Gernot Schabbauer commented on the new collaboration in a recent press release:
»I am very pleased that Cyxone has chosen our lab for its studies. I will work in close collaboration with Christian Gruber, the inventor of T20K and Cyxone, and I have a keen interest in studying the immunomodulating and therapeutic effect of this potentially powerful new therapeutic candidate in our novel experimental design.«
BioStock reached out to Carl-Magnus Högerkorp, COO and Sally Abdelmoaty, Non-Clinical Project Manager at Cyxone, to find out more about why this collaboration is important for the T20K project.
Carl-Magnus, can you explain why the studies that will be conducted in this collaboration are important for driving the T20K project forward?
-The studies with MUV are intended to build further on our understanding of the mode of action of the molecule in the MS setting. We would like to, in greater detail, explore the impact of the treatment in these model systems and with these insights design the continued non-clinical and clinical development path for T20K. In preliminary work at MUV it was discovered that T20K may have additional benefit for patients and this collaboration aims to explore that further and if possible, confirm these results in a preclinical model of MS. The studies also opens up for opportunities to explore biomarkers that are closely linked to the MOA and will be of great importance to when moving the project into the clinic.
You have already performed a clinical phase I trial a couple of years ago. Why have you decided to perform these new studies now?
– The phase I trial that was performed gave us very important impressions on safety and pharmacology enabling us to strengthen our understanding on how our body handles the drug. These are very important observations for deciding on how to dose the drug. However, since we are now exploring a another administration route and the relevant dose range for the drug, it is necessary to conduct follow-up preclinical investigations. This work will form the basis for the non-clinical, IND-enabling studies required before initiating more advanced clinical trials.
When do you foresee to have chosen the administration form that will be used in the clinical phase?
– During the course of the autumn, we will get data from some of our programs that will help us decide which direction we should take with the different administration options we have. Both options have potential, but we will prioritise the route that delivers the best efficacy and safety and secondly prioritise convenience for patients.
Turning to Sally, you will also potentially identify additional benefits for MS patients, and hopefully also find benefits for other subsets of MS. Can you elaborate on this?
-Through deepening our understanding of the specific cells and molecular processes that T20K is targeting, we are aiming to gain insights into other pathologies where T20K can be beneficial. Such information will provide a basis for expanding the scope of the therapy in MS and for exploring new therapeutic opportunities, potentially beyond MS. It is our goal as a company to ensure that we exploit the science fully to deliver as much value as possible to patients.
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