Toleranzia AB signs agreement with a specialist consultancy company for implementation of its preclinical program
7 March - 2016
Toleranzia AB has signed an agreement with Leads to Development SARL (L2D), a consultancy company specializing in preclinical development, commissioning them to lead the efforts to develop the company’s drug candidate up until clinical trials in patients. This means firstly that L2D will take operational responsibility for the design and implementation of scale-up of production of the company’s drug candidate by its contracted producer Biotechpharma UAB. Thereafter, L2D will take operational responsibility for the design and implementation of the stability and formulation studies as well as toxicity and safety pharmacology studies. In addition, L2D will assist in interactions with regulatory authorities, including, among other things, the scientific advice meetings offered within the framework of the orphan drug designation that the company holds for its myasthenia gravis therapy.
Björn Löwenadler, CEO, comments
I am very pleased to announce that we have signed this important agreement with L2D who have unique expertise and international experience in developing biologic products in the immunotherapy field. Thus, we have succeeded in securing a central resource for the implementation of the preclinical program for our drug candidate in myasthenia gravis treatment.
For further information about the above-mentioned agreement or about Toleranzia AB, please contact:
Björn Löwenadler, CEO
Phone: +46 70-631 00 30
About Toleranzia AB
Toleranzia AB (556877-2866) has developed a platform technology for treatment of autoimmune diseases. The company´s main project is directed towards an autoimmune neuromuscular disease, myasthenia gravis, with a significant need for an effective treatment and an extensive market potential, for which Toleranzia has been granted Orphan Drug Designation in both EU and US. The platform technology enables development of therapies that target the root cause of the disease – not just the symptoms, which is the mainstay of current treatment. In addition to myasthenia gravis, the platform technology has been evaluated in three further disease indications – rheumatoid arthritis, multiple sclerosis and type 1 diabetes, where positive treatment effects have been obtained in disease-relevant animal models. Toleranzia was founded by researchers at the University of Gothenburg. The company has operations at the Biotech center in Gothenburg. Further reading at: www.toleranzia.com.
About Leads To Development SARL (L2D)
L2D specializes in the preclinical development of therapeutic products. They offer consultancy as well as regulatory and operational management services in order to help their clients bridge the gap between lead identification and clinical development. Their clients benefit from L2D’s development expertise without having to build additional internal headcount, whilst L2D ensure that their products are advanced rapidly and cost effectively to clinical proof of concept trials. They offer a personal service carefully tailored to their customers’ needs that maintains the transparency, flexibility and availability associated with an internal team. Their expertise covers a wide range of therapeutic product types including small molecules, peptides, proteins, and vaccines, as well as cell and gene therapies. This expertise has been built across a spectrum of disease indications including oncology, neurology, metabolism, infection and immunology, together with auto-immune and inflammatory diseases. Further reading at: www.leadstodevelopment.com.