3P Biopharmaceuticals and Toleranziabegan 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).
The drug candidate
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 favourable 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.
As 3P Biopharmaceuticals CEO Dámaso Molero explains: “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. 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 at Toleranzia, added: “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.
Therefore, this development represents an important advance in the area of rare diseases and highlights the ability to reach the unmet needs of patients through innovation that improves and saves people´s lives.
3P Biopharmaceuticals once again demonstrates its capacity to carry out processes and manufacturing for molecules developed within diverse therapeutic applications. At the same time, 3P Biopharmaceuticals consolidates a competitive position among the most esteemed CDMOs in Europe.