Toleranzia AB announced that it has successfully completed the manufacturing steps of the GMP process for the TOL2 drug substance to be used in the company's first clinical study. Both the upstream and the downstream steps have been run as planned, demonstrating an effective and robust process in line with that of the previous technical batches. Since starting the 1000 L full-scale GMP manufacturing of TOL2 drug substance in the beginning of August, both the upstream fermentation step and downstream purification process have been finalized as planned.

All process parameters and specifications assessed so far meet set requirements fully, in line with those obtained in the two previous technical batches. Following this interim report, Toleranzia is awaiting a report with a full set of TOL2 product analyses currently performed at 3P. When all specifications are met, the GMP manufacturing will be completed and large-scale GMP-grade TOL2 drug substance will be ready for final formulation, packaging, and labeling into a finished TOL2 drug product with GMP quality.

The GMP-grade drug product will subsequently be shipped to participating clinical centers in the upcoming clinical study in myasthenia gravis patients.