Sön 21 jul / År 42 / Nr 3 2024

Pioneers of Tolerance-Inducing Drugs

The Swedish R&D company Toleranzia AB has developed a technology platform for tolerance-inducing pharmaceuticals, which is a new class of medical drugs for treatment of autoimmune diseases.

Toleranzia’s technology platform comprises a unique method for the induction of immunological tolerance in patients with autoimmune disease. “It’s based on a tailor-made protein molecule consisting of three parts; a targeting part, a tolerance-inducing part, and a disease-specific part. The first part targets the molecule so that it reaches the right cells in the body whereas the second part triggers tolerance-promoting functions and the third part is the disease-specific component,” Nils Lycke, CSO of Toleranzia AB, explains.
The goal is to create medical drugs, without side effects, that specifically target only the small fraction of immune cells driving disease in autoimmune patients, while fully maintaining the integrity and function of the immune system, such as immune surveillance of cancer development and host defence against infectious diseases.
”Tolerance-inducing pharmaceuticals is a new class of medical drugs that cannot be found on the market yet. This makes us pioneers, which is very challenging, as it really involves exploring unchartered territory. We plan to take our drug candidate through clinical phase I/IIa trials, while subsequent late stage clinical trial phases are most likely conducted together with partners,” Charlotte Fribert, CEO of Toleranzia AB, explains. The company has been granted patent protection for the tolerogen technology in nine European countries, as well as in Australia, China and Japan. In addition, patents are pending in the USA, Canada and India.

Main Project Directed Towards Myasthenia Gravis
Toleranzia’s main project is focused on a novel treatment of myasthenia gravis, an autoimmune disease involving nerve-muscle signal transduction. But the platform technology has also been evaluated in animal models of type 1 diabetes, rheumatoid arthritis and multiple sclerosis.
”Initially, we have chosen to focus on myasthenia gravis, partly because there is a large unmet need for improved medical treatment of these patients, and partly because the elements causing the disease have been well defined,” says Charlotte Fribert.
”Also, it is a rare disease and our drug candidate has been granted orphan drug designation which involves market exclusivity for ten years in Europe and seven years in the USA, as well as certain tax reliefs and opportunities to conduct small-size clinical trials,” she adds.
Toleranzia plans to initiate clinical trials for their drug candidate in myasthenia gravis during 2017.