Cyxone to Scale Up Production of T20K, Plant-derived Therapy for MS
The collaboration, which will cover the development of a new manufacturing method and later the production of the ingredient for use in research, marks the next step in the Swedish company’s MS research program.
“We are pleased to have established a collaboration with one of Europe’s leading manufacturers of therapeutic peptides,” Tara Heitner, PhD, CEO of Cyxone, said in a press release.
T20K is a plant-derived compound that targets interleukin-2, an inflammatory mediator involved in the breakdown of myelin — the protective substance surrounding nerve cells. Inflammation-induced loss of myelin is a hallmark feature of MS.
In preclinical studies that included work in a mouse model of MS, T20K was reported to slow disease onset and ease symptom severity without toxic side effects.
A subsequent Phase 1a clinical trial in eight healthy men showed that a low dose of intravenous (into-the-vein) T20K was generally well-tolerated and safe.
Cyxone believes that early treatment with T20K could delay MS progression.
“This potentially disease preventing mechanism-of-action is unique and T20K could thus be effective in slowing down the disease progression, preventing disease flares and postponing the need of second-line treatments,” the company states on a webpage.
To support ongoing research efforts, Cyxone and its partner will work to scale up production of T20K’s active ingredient. Cyxone did not disclose the company, referring to it only as a “renowned” European Contract Development and Manufacturing Organization.
The partnership will cover the development and validation of a new method for producing the compound, which, once in place, will ensure its supply to Cyxone for research activities, both clinical and nonclinical.
All steps in the process will meet the standards of Good Manufacturing Practice (GMP), used to ensure consistency and quality during production.
“T20K GMP manufacturing is an important step before non-clinical safety studies and future clinical studies. A feasibility study will be the first step of this collaboration permitting further optimization of the scale up process,” Heitner said.
“The agreement represents our commitment to the T20K program and indicates that we are on schedule with our non-clinical plans,” she added.
Cyxone’s current research efforts are focused on more convenient ways to administer T20K, such as an oral formulation that would make T20K more “patient-friendly,” according to the company. Preclinical toxicology studies for this potential formulation, required for clinical trial approval, will follow.
Cyxone holds patents for T20K in markets that include the U.S., Europe and Australia, and plans to partner with a pharmaceutical company on future projects.