3P Biopharmaceuticals and the Swedish company, Toleranzia AB, have successfully accomplished 1000 L full-scale GMP manufacturing of TOL2 drug substance destinated to be used in clinical study.

The relationship between both companies began in 2019 with 3P being selected as the CDMO to be responsible for the cell line, process and analytical methods development as well as process scale-up to achieve cGMP production of Toleranzia AB’s drug candidate TOL2 for clinical studies (Phase I and II).
Toleranzia is at the forefront of innovation with their groundbreaking candidate, TOL2, designed to address the autoimmune neuromuscular disease, Myasthenia Gravis (MG). MG is a relatively uncommon autoimmune disorder impacting nerve and muscle function and results in profound muscular debilitation. This condition, categorized as an orphan disease, presents a significant unmet medical need and therefore novel treatments for this disease have substantial market potential.

The promising TOL2 candidate has already garnered a series of encouraging preclinical outcomes. These results highlight a favourable safety profile, absence of heightened risk for adverse immunological effects, and notably robust disease-modifying properties, potentially carrying a curative impact. The prospect of substantiating these findings in forthcoming clinical trials holds the potential to revolutionize the landscape for MG patients. Currently all available treatments are solely alleviating symptoms, and TOL2 has the potential to offer MG patients a groundbreaking and efficacious therapy.
Elena Erroba, Chief Commercial Officer at 3P Biopharmaceuticals comments: “At 3P Biopharmaceuticals, our unwavering commitment lies in the health and well-being of patients. We are dedicated to the relentless pursuit of advancing medical science in the battle against myasthenia gravis. Our mission is to provide patients with the hope of a better life, one filled with improved health and well-being. We are deeply excited about embarking on this transformative journey alongside Toleranzia, and together, we aim to make a meaningful difference in the lives of those affected by this challenging condition.”

This collaboration not only exemplifies 3P Biopharmaceuticals’ prowess in executing intricate processes and manufacturing procedures across diverse therapeutic applications but also reinforces its standing as a formidable contender among Europe’s most esteemed Contract Development and Manufacturing Organizations.

Charlotte Fribert, CEO at Toleranzia AB comments: “We are pleased to report that the process has been running smoothly and efficiently at 3P Biopharmaceuticals fully according to plans and the set requirements we established. It is extremely satisfactory for us to conclude this critical milestone in the TOL2 product development program, which takes us an important step closer to the start of our clinical study in patients with myasthenia gravis.”

This partnership serves as a testament to 3P’s expertise in tailoring process development and manufacturing approaches to each client’s distinct requirements, utilizing microbial systems.

About Toleranzia

Toleranzia AB develops drugs that harness the power of the immune system for the treatment of autoimmune orphan diseases. The drugs, which target the cause of the disease, can cure or significantly alleviate the disease and not, like current treatments, merely reduce the symptoms. They have the potential to be the first long-acting or curative therapies that act specifically on the underlying cause of the autoimmune orphan disease for which they are being developed. Toleranzia’s shares are listed on the Nasdaq First North Growth Market and Mangold Fondkommission AB, 08-503 015 50, CA@mangold.se, is the company’s Certified Adviser. For further information: https://www.toleranzia.com/

Image: Adobe Stock photo with paid license of White blood cells in an autoimmune disease.

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