Gothenburg-based Toleranzia develops the drug candidate TOL2 against the autoimmune nerve and muscle disease myasthenia gravis (MG). The company already has solid preclinical results behind it and now only a toxicology study remains before the project can be taken further into the clinic. However, the start of the preclinical sprint has been delayed somewhat due to the covid-19 pandemic, which has put a damper on the production of the drug substance that is intended to be used in the tox study.
Materials needed for the pure production of TOL2 are also required for the production of COVID-19 vaccines, and for much of 2021 and 2022, the production of such vaccines was prioritized over the production of biological drugs under development.
The delays seem to be over.
These problems now appear to be over, however. In its third-quarter report, the company announced that production of a pilot batch had begun. CEO Charlotte Fribert said in a comment to BioStock:
"It's nice to be able to look ahead and put all the delays and manufacturing problems caused by the pandemic behind us. We can't know for sure if some of the problems may recur in the future, but as it stands now, we have no signals that indicate a risk of further delays."
Pilot batch ready for production
Toleranzia can now announce that the production of the pilot batch has been successfully completed at the partner 3P Biopharmaceuticals. All steps in the process have been carried out on a large scale and the results are described as satisfactory. The company states that the yield of pure TOL2 has been higher than expected and the batch will now be analyzed further to validate the purity. After that, two more batches of TOL2 will be manufactured, one intended for use in the toxicology study and one intended for the clinical phase I/II study.
Commenting on the milestone, Fribert writes in a press release:
“We are extremely pleased that all steps carried out in the large-scale manufacturing process for the pilot batch of TOL2 turned out well, despite the significant challenges that the COVID-19 pandemic has posed for the production of biologics. The significantly better than expected yield after the final purification step is encouraging and supports that the manufacturing process will provide sufficient quantities of the drug candidate for the clinical trial in patients.”
Flerie Invest increases its ownership
With this, Toleranzia takes an important step in the TOL2 project, which aims to develop a treatment for MG that targets the underlying cause of the disease. BioStock recently wrote about the increased interest in the MG field, which you can read more about here.
One who has shown great faith in the future of the TOL2 project is Flerie Invest, with Thomas Eldered at the forefront. During the autumn, Flerie Invest has increased its ownership in Toleranzia, which has resulted in exceeding the 30 percent limit that requires a mandatory bid to be made for the company. A bid of SEK 1,02 per share for the remaining shares in Toleranzia has been made, valuing the company at a total of approximately SEK 112 million. The bid corresponded approximately to the price at which Toleranzia's share was traded at the time of the bid, and it can be noted that the share price, after some fluctuations, is still around that level.
Don't want to acquire the whole of Toleranzia
Flerie Invest has announced during this process that it has no ambition to acquire the entire Toleranzia, but that it is the regulations regarding mandatory bids that are behind the bid itself. From Toleranzia's side, the board has announced that it does not recommend shareholders to accept the bid, as it sees a much greater future value for the company than what the bid represents.
Flerie Invest had an ownership stake of 30,4 percent at the time of the bid and it remains to be seen what the ownership will look like after the acceptance period expires on December 14.