Immune Pharmaceuticals Files New Patent Application for Ceplene in Combination with Checkpoint Inhibitors

Feb 10, 2016

NEW YORK, Feb. 10, 2016 /PRNewswire/ -- Immune Pharmaceuticals Inc. (NASDAQ: IMNP), "Immune", a clinical-stage biopharmaceutical company, announced today that it has filed a patent application directed to the treatment of Acute Myeloid Leukemia and other cancers.

The new invention provides methods of treating cancer by administration of Ceplene (histamine dihydrochloride) in combination with immune checkpoint inhibitors. The new invention also provides methods of predicting the efficacy of Ceplene and IL-2 therapy in patients with Acute Myeloid Leukemia.

"This new patent application, if granted, will add substantially to the patent estate surrounding Ceplene," stated Dr. Daniel Teper, Immune's CEO. "The expanded patent life could open up new potential strategic options for the future development of Ceplene in multiple indications."

Ceplene, in combination with low dose IL-2 immunotherapy, met a Phase 3 end point of Progression Free Survival. Ceplene is approved in Europe for remission maintenance and prevention of relapse in adults with Acute Myeloid Leukemia, an orphan indication with poor survival prognosis, for which no effective therapy is available to patients. Ceplene protects the immune system against inactivation and apoptosis induction by leukemic cells, enabling IL-2-stimulated T cells and Natural Killer (NK) cells to eliminate residual leukemia cells and protect patients against relapse.

"There are no approved treatments for maintaining remission in patients with Acute Myeloid Leukemia," said Dr. Miri Ben-Ami, President and EVP of Oncology. "This is a population with high mortality and an unmet need.  The immune checkpoint blocking agents have resulted in major strides in the treatment of cancer in the past few years, and the addition of Ceplene to these checkpoint blockers may potentially open a new paradigm for the treatment of multiple cancer indications, exploiting a novel immune mechanism to provide the next stride in cancer immunotherapy."

About Immune Pharmaceuticals:

Immune Pharmaceuticals (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 oncology pipeline includes Ceplene®, Azixa® and Crolibulin® as well as bispecific antibodies and nanotherapeutics, including NanomAbs. 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 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 non-core pipeline includes AmiKet™, 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.

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SOURCE Immune Pharmaceuticals Inc.

For further information: Danielle Shapira, Manager, Strategic Planning, Immune Pharmaceuticals Inc., 646.440.9327,