NEW YORK, (UPTICK Newswire – Jan. 12, 2016) — Immune Pharmaceuticals Inc. (IMNP), “Immune”, a clinical-stage biopharmaceutical company, announced today that it has prioritized its oncology development programs for 2016. Immune’s oncology pipeline is comprised of three small molecules in mid to late stage clinical development and two novel technology platforms.
Dr. Daniel Teper, Immune’s CEO commented: “We are focusing on disruptive technologies and targets that have the potential to change patient outcomes. In 2016 our goal is to generate data that will support partnerships and accelerate development thereby helping us bring life-changing therapies to cancer patients”.
The company’s Immuno-Oncology programs for 2016 include the following assets and data milestones:
Ceplene® in combination with low dose IL-2 is approved in 27 countries in Europe for remission maintenance and prevention of relapse in adults with Acute Myeloid Leukemia, an orphan indication with poor survival prognosis and no new therapy for many years. Ceplene® protects T Cell and Natural Killer (NK) cells against inactivation and apoptosis enabling IL-2 to eliminate leukemia cells and protect against relapse. Results of a post-marketing study conducted in Europe in a biomarker-defined sub-population are expected in 2016.
Azixa® and Crolibulin are two new vascular disruptive agents (VDAs) with additional anti-tumor activity demonstrated in preclinical studies. Both drugs have shown promising initial efficacy in phase I/II clinical trials in multiple solid tumors, including glioblastoma. Combination studies of VDAs with immune check-point inhibitors are underway in preclinical tumor models. These efforts will help provide the rationale for the design of a new phase II combination clinical study with a check point inhibitor.
Immune’s two novel technology platforms, bispecific antibodies and immuno-nanoparticles(NanomAbs®), will be focused on immuno-oncology and applied to novel targets including immune check points. Pre-clinical validation with selected immune check point targets is planned in 2016.
About Immune Pharmaceuticals:
Immune Pharmaceuticals (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 auto-immune 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 oncology pipeline includes, bispecific antibodies, nanotherapeutics (NanomAbs®), and several mid-to-late stage small molecules. 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 www.immunepharmaceuticals.com, 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 www.sec.gov or at www.immunepharmaceuticals.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, whether as a result of new information, future events or otherwise, except as required by law.
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