New Data Suggests Improved Tumor Response For The Combination of AZIXA® and Immune Checkpoint Inhibitors in The Treatment of Cancer
Immune Pharmaceuticals Files New Provisional Patent Application
Jun 28, 2016
NEW YORK, June 28, 2016 /PRNewswire/ -- Immune Pharmaceuticals Inc. ("Immune" or the "Company") (NASDAQ: IMNP), a clinical-stage biopharmaceutical company announced today that recent preclinical experiments conducted by Dr. Boris Shor, Immune's executive director of R&D, in collaboration with an independent U.S. based Clinical Research Organization in a murine colon cancer model, demonstrated that the combination of Azixa® and immune checkpoint inhibitors such as anti-CTLA-4 antibody resulted in enhanced activity compared to the activity elicited by the single agents alone, independent of the dose of Azixa®.
As a result, Immune has filed a provisional patent application with the United States Patent and Trademark Office ("USPTO") relating to the combination of Azixa® (veribulin), a microtubule binding vascular disrupting agent ("VDA"), in combination with the immune checkpoint inhibitors such as an anti-CTLA-4 antibody and anti-PD1 monoclonal antibodies in the treatment of cancer.
Azixa ® has been noteworthy among VDAs due to it not being a substrate for efflux pumps and achieving high CNS concentrations. One hundred and sixty-nine patients have been treated to date with Azixa® in multiple phase I and phase II clinical trials. Following this initial demonstration that the drug functions synergistically with immune checkpoint inhibitors to enhance suppression of growth of cancer in animal models, additional pre-clinical and clinical studies are planned to elucidate the mechanisms underlying these synergistic effects and the potential patient benefits.
"Combination treatments have the potential to augment the response to immune checkpoint inhibitors" stated Dr. Daniel Teper, CEO of Immune Pharmaceuticals, Inc. "Azixa® had previously demonstrated pre-clinical and clinical activity in multiple tumor types. The recent data opens up new potential strategic options for the future clinical development of Azixa®. Additionally, the new patent, if granted, adds substantially to the patent estate surrounding Azixa®."
Azixa® (veribulin) is a novel microtubule destabilizer that both functions as a potent cytotoxin and acts as a vascular disrupting agent (VDA). It is capable of evading multidrug resistance pumps and, thus, achieves high CNS concentrations. It is efficacious in multiple xenograft models without CNS toxicity. 169 patients have been treated to date with Azixa® in multiple phase I and phase II clinical trials. Azixa® has obtained Orphan Drug Designation in the United States for Glioblastoma (GBM).
About Immune Pharmaceuticals:
Immune Pharmaceuticals (NASDAQ: IMNP) applies a personalized approach to treatment and development of novel, highly targeted therapeutics to improve the lives of patients with inflammatory diseases and cancer. Immune's oncology pipeline includes bispecific antibodies, nanotherapeutics, including NanomAbs®, and several mid-to-late stage small molecules including Ceplene®, Azixa® and Crolibulin®. Ceplene® is approved in over 30 European countries and Israel. Immune's lead product candidate for the treatment of inflammatory disease, 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 www.immunepharmaceuticals.com, the content of which is not a part of this press release.
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.
SOURCE Immune Pharmaceuticals Inc.
For further information: Danielle Shapira, Manager, Strategic Planning, IMMUNE Pharmaceuticals, Inc., 646.440.9327, firstname.lastname@example.org