CYTOVIA Inc., IMMUNE Pharma’s Oncology Subsidiary, Announces the Publication of New Results in the British Journal of Haematology and Filing of a World-wide Patent Protecting the Use of Ceplene® in Chronic Myeloid Leukemia (CML)

NEW YORK–(BUSINESS WIRE)– Cytovia, the oncology subsidiary of Immune Pharmaceuticals (NASDAQ:IMNP)
(« Immune » or the “Company”), a clinical stage biopharmaceutical company,
today announced the publication of new results supporting the benefits
of its lead compound Ceplene® (histamine dihydrochloride). In parallel,
Cytovia has filed a world-wide patent to protect the use of Ceplene® in
CML. In the British Journal of Haematology new publication (https://www.ncbi.nlm.nih.gov/pubmed/28542840),
the authors show that the genetic elimination of NOX2 function delayed
the development of CML in mice and prolonged survival. These results
support that Ceplene®, or other inhibitors of NOX2 function, may be
efficacious in CML.

In the US, there are approximately 100,000 patients living with CML. The
patients receive tyrosine kinase inhibitors including imatinib
(Gleevec®, Glivec®), which have dramatically improved long-term
survival. However, treatment with Gleevec® or other tyrosine kinase
inhibitors is typically life-long with high medication costs and
significant side-effects to therapy.

During treatment with tyrosine kinase inhibitors in CML, a small clone
of leukemic cancer cells persists in most patients. Hence a method to
further reduce or eliminate the burden of leukemic cancer cells would be
of benefit to patients with CML.

“Inhibition of NOX2 is a novel and conceivable strategy to reduce the
burden of malignant cells in patients with CML,” said Kristoffer
Hellstrand, MD, PhD and professor of tumor immunology at the University
of Gothenburg, Sweden. “We are interested in evaluating the potential
efficacy of the combination of Ceplene® and low-dose IL-2 in CML
patients.”

Dr. Daniel Teper, CEO of Cytovia adds: “We are delighted of the renewed
scientific interest in Ceplene as demonstrated by the high quality data
published in peer reviewed journals and the new patent filings. The
spin-off of Cytovia from Immune will provide us the focused resources to
commercialize Ceplene in AML, initiate clinical studies in new
indications, including CML, and potentially expand Ceplene market
opportunity.”

About Ceplene

Ceplene® (histamine dihydrochloride) is an immunostimulant that is
approved for use in over 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
activation of 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 over 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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