Hope for a new treatment for the autoimmune neuromuscular disease Myasthenia Gravis (MG)

3P Biopharmaceuticals, a leading Contract Development and Manufacturing Organization (CDMO) specialized in process development and cGMP manufacturing of biologics, together with Toleranzia, a Swedish Biotech company, have initiated a collaboration on innovative treatment for the autoimmune neuromuscular disease Myasthenia Gravis (MG).

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).

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.

cGMP production

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.

>a href=”https://www.toleranzia.com/biostock-artikel-toleranzia-tar-inga-genvagar-i-uppskalningen-av-produktionen-av-tol2/” target=”_blank”>Source of information:

Our dedicated team of specialists will be happy to discuss any of your cGMP production needs. Contact us on +34 948 346 480 or email itswithinus@3pbio.com

Related Content

3P Biopharmaceuticals presents its growth plan at BIOSPAIN to further expand its operations in Europe and the USA

The investments will enable the company to increase its mammalian cell-based protein production capacity tenfold and increase its microbial cell-based protein production capacity by 50%. The total floor space of the company will triple.
Read more

3P Biopharmaceuticals appoints Diego Bochoeyer as Director of Strategic Development and Supply Chain

3P Biopharmaceuticals incorporates a new member to the executive management team by engaging Diego Bochoeyer as Director of Strategic Development and Supply Chain.
Read more

3P Biopharmaceuticals enters into alliance with Precirix to develop precision radiopharmaceuticals in oncology

3P Biopharmaceuticals and Precirix NV have signed an agreement for the clinical manufacturing of a camelid single-domain antibody fragment (sdAb), the backbone of Precirix’ next product candidate to enter the clinic.
Read more

Get in touch

Let’s discuss your biologics journey.

Discover more about our people, our passion, and how we can work together to improve lives.