Toleranzia AB (publ) announced that it has successfully manufactured and evaluated a pilot batch of its drug candidate TOL2 at the contract manufacturer 3P Biopharmaceuticals (3P). In the execution of the pilot batch, all steps of the manufacturing process have been carried out on a large scale with satisfactory results. The company will now move forward with the development of TOL2 and conduct a toxicology study as the final step prior to the start of clinical trials in patients with myasthenia gravis.

Toleranzia concludes after the evaluation that all steps in the purification process of the pilot batch have been in accordance with expectations and requirements. The pilot batch resulted in a higher yield of pure TOL2 after the last step of the process than expected. A detailed mass spectrometric analysis is now being carried out to validate the quality of the purified material.

The material from the pilot batch will be used mainly for the remaining formulation work. With the positive data from the pilot batch Toleranzia is now advancing the manufacturing program to produce two additional large-scale batches of TOL2, one technical batch for the regulatory GLP toxicology study and thereafter one GMP batch for the clinical trial in patients.