IMMUNE Pharmaceuticals’ Oncology Subsidiary, CYTOVIA, Announces the Filing of a World-Wide Patent Protecting the Use of Ceplene® in Acute Myeloid Leukemia (AML) and Other Hematological Cancers with Mutated NPM1

NEW YORK–(BUSINESS WIRE)– Cytovia, Inc. (“Cytovia”) the oncology subsidiary of Immune
Pharmaceuticals Inc. (NASDAQ:IMNP) (« Immune » or the “Company”), a
clinical stage biopharmaceutical company, announced the filing of a
patent protecting the use of Ceplene® (histamine dihydrochloride) in
hematologic cancers. The new patent is based on favorable clinical
results in patients with acute myeloid leukemia (AML) who had persistent
cancer cells in their bone marrow. The patent aims to protect the use of
Ceplene® in forms of cancer where malignant cells may harbor a mutated
oncogene, NPM1^mut(mutated nucleophosmin gene).
These forms of cancer include AML, non-Hodgkin lymphoma, acute
promyelocytic leukemia and myelodysplastic syndrome.

A mutated NPM1 gene (NPM1^mut) is found in cancer cells
in approximately 25-30% of patients with AML. The presence of NPM1^mut cancer
cells in bone marrow after the completion of chemotherapy (i.e.
persistence of leukemic cells or “minimal residual disease”) is
associated with high relapse risk and poor overall survival. In a recent
clinical study in the New England Journal of Medicine only 19% of adult
AML patients in complete remission with persistence of NPM1^mut cancer
cells remained relapse-free, and only 40 % survived for more than 2
years (Ivey et al., 2016).

In Cytovia’s proprietary Re:Mission phase IV trial in AML, adult
patients in complete remission received Ceplene® and low-dose IL-2 to
prevent relapse. At onset of treatment with Ceplene®/IL-2, nine patients
(51-76 years old) had persistent NPM1^mut cancer
cells in bone marrow. Five of these 9 patients (58%) remained
relapse-free, and 6/9 patients (78%) survived for more than 2 years.

“The persistence of NPM1^mut leukemic cells after
the completion of chemotherapy heralds poor prognosis in AML, and no
targeted therapy is available for these patients,” said Dr. Anna Martner
at the Sahlgrenska Cancer Center, University of Gothenburg. “Our results
merit an extended clinical trial aiming to clarify to what extent
treatment with Ceplene®/IL-2 may eradicate persistent leukemia.”

“We are encouraged by these new results,” said Dr. Daniel Teper, of
Cytovia. “The Company is in discussion with leading hematologists to
pursue larger studies aiming to confirm the clinical benefit of
Ceplene®/IL-2 in multiple hematological cancers with overexpression of NPM1^mut
.”

The Re:Mission phase IV trial studied 84 AML adult patients who received
Ceplene and low-dose IL-2 to prevent relapses. For details of the trial
design, please visit https://clinicaltrials.gov/ct2/show/NCT01347996?term=ceplene&rank=1.

Most Patients with AML initially achieve complete remission from
leukemia after receiving chemotherapy. However, the majority of adult
patients will experience relapse of AML with poor prospects of long-term
survival. Ceplene®, used in conjunction with low-dose IL-2, has been
developed to prevent relapses in the post-chemotherapy phase of AML. A
previous phase III trial in 320 patients confirmed the efficacy of
Ceplene®/IL-2 in preventing relapse of AML.

Ceplene, in combination with low-dose Proleukin (interleukin-2 (IL-2)),
has been approved in over 30 countries in Europe and in Israel for the
treatment of AML for maintenance of remission and prevention of relapse
of leukemia. For the vast majority of AML patients there is currently no
other approved therapy to prevent relapse post first remission.

About Ceplene

Ceplene (histamine dihydrochloride) is an immunostimulant that is
administered in conjunction with low-dose interleukin-2 (IL-2), for
maintenance of first remission in patients with AML. Ceplene has been
shown in an international phase III clinical study to prevent relapse of
leukemia in AML patients in first remission while maintaining good
quality of life during treatment. Ceplene acts by countering dysfunction
and apoptosis of T and NK cells, thereby inducing immune-mediated
killing of leukemic cells, providing a strong pharmacological rationale
for the combination therapy. A recent Phase IV study presented at the
meeting of the American Association for Cancer Research in 2016
supported the safety and efficacy of Ceplene demonstrated in the
international phase III study. Following Cytovia’s recent acquisition of
Ceplene from Mylan, the Company now holds worldwide rights for Ceplene.

About AML

AML patients receive intensive induction treatment with chemotherapeutic
drugs at diagnosis, and typically become free of detectable leukemia,
achieving « complete remission ». However, within 1-2 years the majority
of adult patients will experience a relapse of leukemia, of which the
prognosis for survival is 33% in younger patients and 15-20% in patients
over 60 years of age. According to the American Cancer Society, there
will be approximately 21,380 new cases of AML and 10,590 deaths from AML
in the US in 2017. AML represents an orphan indication with particularly
high unmet need.

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 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.

Forward-Looking Statements

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Forward-looking statements include, among others, statements regarding
the Company’s ability to reduce expenses, capitalize on strategic
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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.

There can be no assurance that the Company will ever successfully
complete its anticipated corporate restructuring, or that the Company
will be able to reduce expenses, capitalize on strategic alternatives,
develop its assets, and generate value for shareholders. Factors that
may cause actual results or developments to differ materially include,
but are 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 ongoing or
future clinical trials will not be successful; the risk that our
compounds under development 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 future trials or commercialize
our product candidates on attractive terms, on a timely basis or at all;
the risk that our product candidates that appear 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. There is no certainty that Cytovia or its
commercial partners will achieve a certain market share of the
addressable market in AML. There is also uncertainty that the
reimbursement price will be maintained in Europe or that it will
accepted in Latin America. In addition, among other risks, there can be
no guarantee that concomitant investment by Pint will be completed, or
if it is completed, that it will close within the anticipated time
period or that the expected benefits of the licensing and investment
agreements will be realized.

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
our 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 www.sec.gov or
at www.immunepharma.com.
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 (including those relating to the corporate
reorganization and exploration of strategic alternatives), whether as a
result of new information, future events or otherwise, except as
required by law.

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