Product Pipeline / Overview

Targeted biological therapies have revolutionized the treatment of immune-mediated inflammatory diseases and cancer.

With currently three drug candidates in the pipeline, Baliopharm develops innovative monoclonal antibody-based therapeutics for immune mediated inflammatory diseases and chronic liver diseases as well as for oncological indications.


Immune-mediated inflammatory diseases

The incidence of immune-mediated inflammatory diseases in developed countries is about 5-7% including, among others, diseases like rheumatoid arthritis (RA), psoriasis, Crohn`s disease (CD) and colitis ulcerosa. Moreover, several neuro-inflammatory and neurodegenerative disorders like multiple sclerosis or Parkinson are known to be immune-mediated.

The discovery that clinically unrelated conditions, such as RA, psoriasis and CD share similar immune dysregulation, has led to a shift in the management of immune-mediated inflammatory diseases from organ-based symptom relief to mechanism-based treatment. Especially monoclonal antibodies have become a well validated and established treatment option for several of these indications. However, there is significant potential for improvement regarding their specificity and drug mediated side effects.

Baliopharm approaches the treatment of inflammatory diseases with its drug candidates Atrosab and Atrosimab, which both specifically target the pro-inflammatory tumor necrosis factor receptor 1 (TNF-R1), thereby blocking its activation by TNF-alpha. The antagonistic interaction with TNF-R1 prevents NFkB mediated pro-inflammatory cytokine release and the subsequent emergence of inflammatory responses. At the same time, since both drug candidates do not bind to the TNF-receptor 2, positive immune responses via the TRAF2 pathway are maintained and severe side effects of other TNF antagonists, such as neurological disorders and opportunistic infections, are eliminated.

Our bispecific antibody Novotarg is a promising compound for the treatment of autoimmune diseases associated with B lymphocyte involvement, like e.g. multiple sclerosis. Marketed anti-CD20 antibodies have already been shown to be clinically effective in multiple sclerosis, however they also cause serious side effects by killing CD20 positive cells irrespectively if they are malignant or not. Novotarg has been specifically designed to target cells that simultaneously express CD20 and CD95 on their surface. Since the “cell-death-receptor” CD95 is exclusively expressed on activated B-cells but not on resting cells, the agonistic activity of Novotarg mediates targeted killing of malignant B-lymphocytes only. 


Chronic liver diseases

With the TNF-alpha pathway being involved in the progression of chronic liver diseases leading to fibrosis, a therapeutic antibody approach could represent a valuable strategy for the prevention or treatment of diseases like Nonalcoholic steatohepatitis (NASH).
In preclinical studies, the efficacy of Atrosab in NASH has already been demonstrated in vitro and in vivo. Atrosab and its follow-on product Atrosimab are thus further developed as stand-alone treatment options for chronic liver diseases as well as in combination with Promethera’s cell-based medicines such as the HepaStem technology. For more information about Promethera´s development pipeline, visit https://www.promethera.com/products-pipeline.


B-cell malignancies

In addition to the treatment of certain autoimmune diseases, our first anti-CD20 and anti-CD95 bispecific antibody Novotarg is an ideal drug candidate for the treatment of B-cell malignancies like B-cell lymphoma and chronic lymphocytic leukemia (CLL).