Cytovia, Inc., Immune Pharma’s Oncology Subsidiary, Announces Publication Of Results Showing Anti-Metastatic Properties Of Its Lead Drug Ceplene And Filing Of A New Worldwide Patent

NEW YORK--(BUSINESS WIRE)--Cytovia, the oncology subsidiary of Immune Pharmaceuticals Inc. (NASDAQ:IMNP) ("Immune"), a clinical stage biopharmaceutical company, today announced the publication of results showing favorable effects of its lead immunotherapeutic compound Ceplene^® (histamine dihydrochloride) in cancer.

The results of the new article confirm and extend previous findings showing that treatment of mice with Ceplene^® efficiently reduces the formation of lung melanoma metastases. Using genetically modified mice, the authors also show that the beneficial effect of treatment with Ceplene^® in reducing metastasis was likely explained by its inhibitory effect on NOX2, which is an enzyme expressed by myeloid blood cells. In the article, the investigators additionally report that combination immunotherapy with Ceplene^® and interleukin-15 (IL-15) reduced melanoma metastasis by over 70%, an incremental effect over Ceplene alone or IL-15 alone.

The article was published in Cancer Immunology Research and is found on this link: https://www.ncbi.nlm.nih.gov/pubmed/28760732

“Cytovia has recently filed a patent aiming to protect the use of Ceplene^® and other inhibitors of NOX2 in reducing or preventing cancer metastasis,” said Dr. Daniel Teper, CEO of Cytovia. He added: “The reduction of metastasis obtained by the combination of Ceplene^® and IL-15 is suggestive of a novel combinatorial immunotherapy that merits further study.”

About Ceplene

Ceplene^® (histamine dihydrochloride) is an immunostimulant that is approved for use in >30 countries in Europe for the maintenance of first remission in patients with acute myeloid leukemia (AML). Ceplene^® is administered in conjunction with low-dose IL-2 for enhanced anti-tumor immunity. Specifically, Ceplene^® acts by countering NOX2-mediated immunosuppression and thus improves activation of anti-tumor lymphocytes such as T cells and NK cells. When administered together with the T cell/NK cell activator IL-2, Ceplene^® promotes immune-mediated killing of cancer cells, thus providing a strong pharmacological rationale for this combination immunotherapy. Aspects on the effects of Ceplene^® on anti-tumor immunity have been reported in >50 scientific articles.

In an international Phase III clinical study in 320 AML patients, the combination of Ceplene^® and low-dose IL-2 has been shown to prevent relapse of leukemia while maintaining good quality of life during treatment. A recent Phase IV study in 84 AML patients demonstrated efficient activation of anti-tumor immunity during treatment with Ceplene^®/IL-2 and also identified tools that may prognosticate the clinical benefit of the treatment. During 2015-17, detailed results of the Phase IV study were presented in several medical journals including Leukemia, a leading journal in hematology. Following the recent acquisition from Mylan, Cytovia holds worldwide rights for Ceplene^®.

About Immune Pharmaceuticals Inc.

Immune Pharmaceuticals Inc. (NASDAQ: IMNP) is dedicated to alleviating the burden of patients suffering from autoimmune diseases by developing novel immunotherapeutic agents. Immune's lead product candidate, bertilimumab, is in Phase 2 clinical development for bullous pemphigoid, an orphan autoimmune dermatological condition, and for ulcerative colitis. Other potential relevant indications for bertilimumab include atopic dermatitis, Crohn's disease, severe asthma and Non-Alcoholic Steato-Hepatitis (NASH). Also, Immune’s pipeline includes topical nano-formulated cyclosporine-A for the treatment of psoriasis and atopic dermatitis and AmiKet™ and AmiKet™ Nano™ for the treatment of neuropathic pain.

Immune's oncology subsidiary, Cytovia, plans to develop and commercialize Ceplene for maintenance remission in AML in combination with IL-2. Additional oncology pipeline products include Azixa^® and crolibulin, which are clinical stage vascular disrupting agents, and bispecific antibodies and NanomAbs™, which are novel technology platforms.

For more information, please visit Immune's website at www.immunepharma.com, the content of which is not a part of this press release.

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