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, the content of which is not a part of this press release.

Forward-Looking Statements

This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal" or the negative of those words or other comparable words to be uncertain and forward-looking. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include, but not limited to: the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern; the risks associated with our ability to continue to meet our obligations under our existing debt agreements; the risk that clinical trials for bertilimumab or AmiKet will not be successful; the risk that bertilimumab, AmiKet or compounds arising from our NanomAbs program will not receive regulatory approval or achieve significant commercial success; the risk that we will not be able to find a partner to help conduct the Phase III trials for AmiKet on attractive terms, on a timely basis or at all; the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later-stage clinical trials; the risk that we will not obtain approval to market any of our product candidates; the risks associated with dependence upon key personnel; the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; and risks associated with our ability to protect our intellectual property. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings, which are available at or at You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors. We expressly disclaim any obligation to publicly update any forward looking statements contained herein, whether as a result of new information, future events or otherwise, except as required by law.

SOURCE Immune Pharmaceuticals Inc.

For further information: US - Danielle Shapira, Manager, Strategic Planning, 646.440.9327,; Europe - Anna Baran, Investor Relations, Senior Director, +44.752.108.3006,

print email rss