3P Biopharmaceuticals and Toleranzia began their partnership in 2019, when 3P Biopharmaceuticals was selected to be responsible for the cell line, process and analytical
methods development as well as process scale-up with the goal of achieving cGMP production in 2021 for clinical studies (Phase I and II).
Toleranzia’s innovative candidate (TOL2) is being developed for the treatment of the autoimmune neuromuscular disease Myasthenia Gravis (MG), an orphan disease, which has a major unmet medical need and a large market potential.
In this regard, MG represents a relatively rare autoimmune nerve and muscle disease that leads to severe muscle weakness. At present, the TOL2 candidate has achieved several positive preclinical results that indicate a favorable safety profile, no increased risk of undesirable immunological effects, and very good disease-modifying properties with potentially curative effect.
If these results can be confirmed in upcoming clinical trials, TOL2 has the potential to constitute
a paradigm shift for people with MG, who are currently given only symptom-relieving treatments. Positive study results would open the door to developing effective and pioneering therapy.
"Currently there are enormous opportunities offered by biotechnology as we can help to develop treatments for rare diseases or those without current therapeutic approaches, such as MG,” said Dámaso Molero, chief executive officer, 3P Biopharmaceuticals. “Therefore, this pioneering project offers a bright hope for improving the lives of patients affected by the autoimmune neuromuscular disease Myasthenia Gravis.”
Bjorn Lowenadler, chief business officer, Toleranzia, said, "We are delighted to collaborate with 3P Biopharmaceuticals for the scaling up and manufacturing of our important biological drug candidate TOL2. 3P was selected as the CDMO of choice based on their state-of-the-art infrastructure, work-force expertise and track-record”.
In order to advance to the clinic, Toleranzia will first require large-scale TOL2 production of GMP quality. 3P Biopharmaceuticals will manufacture TOL2 to allow Toleranzia to complete remaining toxicology, stability and formulation studies. 3P Biopharmaceuticals will also produce the GMP quality substance required for Phase I / II clinical studies.