New Data Suggests Improved Tumor Response For The Combination of AZIXA® and Immune Checkpoint Inhibitors in The Treatment of Cancer
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.
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SOURCE Immune Pharmaceuticals Inc.