Press release 2017-12-20 – Toleranzia AB (“Toleranzia”) hereby announces that the company has entered into an agreement with the French contract manufacturer PX’Therapeutics SAS (“PX'”) for large scale production of the drug candidate TOL2.
The agreement means that PX’ first will manufacture TOL2 for the remaining preclinical studies of toxicity, stability and formulation, and then produce material according to GMP (good manufacturing practice) for the first clinical study. Production according to GMP means that the production meets the quality requirements that the authorities have for the commercialization of the product.
Toleranzia already has a laboratory scale manufacturing process for TOL2. Under the new agreement, PX’ will scale up production so that sufficient quantities of material, that meet the European medicines Agency (EMA) requirements, can be produced to initiate tox studies in Q3, 2018. PX’ is a well-established contract manufacturer with extensive expertise and experience of the manufacturing method used for TOL2, as well as ressources to meet Toleranzia’s requirements for timelines.
Toleranzia’s CEO Charlotte Fribert comments
“We are very pleased to have signed an agreement with PX’, which means that, very soon, after hoosing a new drug candidate, we will start industrial production of TOL2 for our upcoming preclinical and clinical studies.”
PX’s COO Claire Untereiner comments
“We are excited to start this collaboration with Toleranzia’s team for the development of TOL2. We really hope that this project will be a success and will lead to the development of a therapeutic solution for the patients who are suffering from myasthenia gravis.”
For further information, please contact
Charlotte Fribert – CEO
Phone: +46 763 19 98 98
Claire Untereiner – COO
Phone: +33 4 38 02 36 50
This information is information that toleranzia AB is obliged to make public pursuant to the securities Markets Act. The information was submitted for publication on December 20, 2017.
About Toleranzia AB
Toleranzia AB (556877-2866) is a Swedish public biotechnology company listed on AktieTorget. The company has developed a proprietary tolerance technology portfolio harnessing the power of the immune system for treatment of autoimmune diseases. The platform technology enables development of therapies that target the root cause of the disease – not juste the symptoms, which is the mainstay of current treatment. The company’s main focus is directed towards the autoimmune neuromolecular disease myastenia gravis (MG), which is an orphan disease with a high unmet medical need. The disease prevalence is approximately 200,000 people in the EU and the US together. The hallmark of MG is a deteriorated neuromuscular transmission of electrical impulses which leads to muscle weakness that can become very serious for the patient. Toleranzia was founded by researchers at the University of Gothenburg. The company operates at the Biotech center in Gothenburg. For additional information, please visit: www.toleranzia.com.
About PX’Therapeutics SAS
PX’Therapeutics SAS is a Contract Development and Manufacturing Organization (CDMO) specializing in the development of biologics (proteins including antibodies and antibody fragments, cells, and micro-organisms), for research and clinical applications. With more than 1000 projects implemented since its creation in 2000, PX’Therapeutics is recognized for its scientific expertise coupled with state-of-the-art GMP capacities, in addition to team flexibility and committed dedication to the success of customers’ projects. Today, the company’s mission is to accelerate the development of biologics thanks to a combination of services, from lead candidate optimization and process development through to GMP manufacturing and CMC consulting. Further information on www.px-therapeutics.com.