Immune Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company focusing on the treatment of immuno-inflammatory diseases and cancer. The company has several active clinical programs, led by bertilimumab, a first-in-class, fully human IgG4 monoclonal antibody, which is currently in Phase 2 clinical trials for the treatment of inflammatory bowel disease and skin disorders. Immune Pharma also has a growing presence in immuno-oncology, with the goal to create a fully sustained oncology subsidiary in the near future. In this article for The Life Sciences Report, analyst Jason Napodano digs into the company’s pipeline and investment potential.
Bertilimumab in the Forefront
Immune Pharmaceuticals Inc. (IMNP:NASDAQ) is currently enrolling patients in two Phase 2 clinical trials with bertilimumab for the treatment of ulcerative colitis (UC) and bullous pemphigoid (BP). A third Phase 2 program in atopic dermatitis (AD) is planned for later in 2016.
Data from the Phase 2a program in BP is expected in late 2016. This open-label, proof-of-concept, single group study targets 10-15 adult patients with newly diagnosed, moderate to extensive BP (NCT0222146). Patient recruitment is occurring at two medical centers in Israel, with plans to open as many as six sites in the U.S. during Q2/16 or Q3/16. Additional sites in Europe are expected to come online shortly, which should greatly speed enrollment in the trial.
“If successful, Immune Pharmaceuticals Inc.’s expansion into oncology will provide diversification and potential upside to the core inflammatory and dermatology focus.”
The scientific rationale for the use of bertilimumab in BP is extensive. Bertilimumab binds to eotaxin-1, a master regulator of the immune cellular network, by inducing key immune cytokine responses with very high affinity and specificity. A study published in the European Journal of Dermatology found an increased level of serum eotaxin-1 in BP patients compared to healthy controls. Eotaxin-1 has also been correlated with disease severity, with the highest levels of eotaxin-1 in patients suffering from the most severe disease, suggesting a correlation between the level of eotaxin-1 over-expression and disease severity.