New Data shows that Ceplene® Enhances Response to anti PD-1 and anti-PD-L1 Immune Checkpoint Inhibitors in Lymphoma and Solid Tumor Models

New Data Presented at the Conference "Regulatory Myeloid Suppressor Cells: From Basic Discovery to Therapeutic Application" Expands Knowledge of Ceplene® Mechanism of Action and Identifies Potential New Indications for Solid Tumors and Lymphoma

Jun 20, 2016

NEW YORK, June 20, 2016 /PRNewswire/ -- Immune Pharmaceuticals (NASDAQ:IMNP),("Immune"),  a clinical stage biopharmaceutical company announced that  scientists from Gothenburg University, Sweden reported that new mechanistic and tumor growth inhibition data with Ceplene ® (histamine dihydrochloride) in combination with immune checkpoint inhibitors targeting PD-1 and PD-L1 in Acute Myeloid Leukemia (AML), lymphoma and breast cancer models, has been presented in Poster Session 2 on Saturday, June 18th,  at 1:00 pm at the conference on "Regulatory Myeloid Suppressor Cells: From Basic Discovery to Therapeutic Application" held at the Wistar Institute in Philadelphia, PA.

Prof. Kristoffer Hellstrand, laboratory chief at the Sahlgrenska Cancer Center of Gothenburg University and Ceplene ® inventor stated: "These in vivo results imply that Ceplene ® suppresses tumor growth by inhibiting NOX-2, a type of immune check point. The data also suggest that Ceplene ® significantly improves the anti-tumor efficacy of immune checkpoint inhibitors targeting PD-1 and PDL-1 in cancer forming the basis for the clinical development of Ceplene ® and other immune checkpoint inhibitors in lymphomas and solid tumors." 

Ceplene ®, in combination with low-dose SC Proleukin® (Interleukin-2 (IL-2)), has been approved in over 30 countries in Europe and Israel for the treatment of AML for maintenance of remission and prevention of disease relapse, an indication for which there are currently no other approved therapies.

In the first presentation, H. Grauers Wiktorin, et al, demonstrated decreased accumulation of myeloid-derived suppressor cells (MDSC) in the tumors accompanied by decreased growth in breast and lymphoma murine cancel models. MDSC harvested from Ceplene- treated animals demonstrated significantly less NOX2-derived Reactive Oxygen Species (ROS) and consequent loss of ability to inhibit T-cell proliferation as compared to MDSC from non-treated animals. Moreover, when combined in these models with checkpoint inhibitors targeting PD-1 and PDL-1, growth inhibition was markedly enhanced compared to either Ceplene ® or the checkpoint inhibitors alone.

In the second presentation, R. Kiffin, et al. demonstrated that Ceplene®-induced downregulation of NADPH Oxidase (NOX2) resulted in increased differentiation and decreased growth of human myelomonoblastic PLB-985 (PLB) xenografts in immunodeficient mice. This provides further mechanistic evidence to explain the striking efficacy of Ceplene ® in combination with low dose IL-2 observed clinically in the myelomonocytic M4 and M5 AML subtypes in both Phase III and Phase IV clinical trials. These results suggest that Ceplene®, in addition to its previously documented role as an innate immune check point inhibitor, acts also as a maturation agent in AML decreasing the tumor's ability to proliferate.

About Immune Pharmaceuticals Inc.:

Immune Pharmaceuticals Inc. (NASDAQ: IMNP) applies a personalized approach to treating and developing novel, highly targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer. Immune's lead product candidate, bertilimumab, is in Phase II clinical development for moderate-to-severe ulcerative colitis as well as for bullous pemphigoid, an orphan autoimmune dermatological condition. Other indications being considered for development include severe atopic dermatitis, Crohn's disease, severe asthma and NASH (an inflammatory liver disease). Immune recently expanded its portfolio in immuno-dermatology with topical nano-formulated cyclosporine-A for the treatment of psoriasis and atopic dermatitis. Immune's oncology pipeline includes Ceplene® approved in combination with lose dose SC IL-2 in Europe and Israel for maintenance remission in AML, Azixa and crolibulin, Phase II-ready vascular disrupting agents, and novel technology platforms; bispecific antibodies and targeted nanotherapeutics, NanomAbs. Immune's additional pipeline includes AmiKet Nano™, a late clinical stage drug candidate for the treatment of neuropathic pain. For more information, visit Immune's website at www.immunepharmaceuticals.com, the content of which is not a part of this press release.

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SOURCE Immune Pharmaceuticals Inc.

For further information: US - Danielle Shapira, Manager, Strategic Planning, 646.440.9327, danielle.shapira@immunepharma.com; Europe - Anna Baran, Investor Relations, Senior Director, +44.752.108.3006, anna.baran@immunepharma.com


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