Immune and BioNanoSim Enter Agreement to Develop Novel Topical Nano-Capsule Formulation of Cyclosporine

01/04/2016

Immune Pharmaceuticals Inc. entered into an exclusive worldwide licensing and development agreement with BioNanoSim Ltd. for a novel topical nano-capsule formulation of cyclosporine, also known as cyclosporine-A or CsA.

Monica Luchi, M.D., Chief Medical Officer of Immune, commented: "Oral cyclosporine, a potent immunosuppressive drug, known to reduce the activity of the immune system by interfering with T-cells, has revolutionized transplantation medicine. Its use in dermatology has been limited to severe cases of psoriasis and atopic dermatitis, because of significant systemic toxicity. In a validated human skin model of atopic dermatitis, a novel topical nano-capsule formulation of cyclosporine A demonstrated comparable efficacy to a high potency topical corticosteroid. We believe that this product candidate could provide an important therapeutic alternative for millions of patients with chronic inflammatory skin disorders such as moderate atopic dermatitis and psoriasis. We intend to accelerate the development of this product candidate under the abbreviated 505(b)(2) drug development pathway permitted by the U.S. Food and Drug Administration."

This topical nano-capsule formulation of cyclosporine incorporates a patented technology invented by Professor Simon Benita, the former Director of the Institute for Drug Research and Head of the School of Pharmacy at the Hebrew University of Jerusalem. Professor Benita has pioneered a nano-drug delivery platform for improving the absorption of poorly absorbed drugs. He recently succeeded in incorporating cyclosporine into a nano-capsule formulation that can be absorbed through the skin.  In validated preclinical animal and human skin models, this new topical formulation was shown to deliver therapeutic levels of cyclosporine to targeted skin layers and to limit systemic absorption. "We believe that this collaboration with Immune will leverage our nanotechnology expertise and advance this novel product candidate into the clinic," said Professor Benita.

"This product candidate -topical cyclosporine nano-capsules- builds on Immune's focused Immuno-dermatology franchise. Bertilimumab, our clinical stage monoclonal antibody is currently in phase II for the treatment of bullous pemphigoid, an orphan auto-immune skin disorder, and will be further developed for severe atopic dermatitis" said Dr. Daniel Teper, Immune's CEO.

Under terms of the agreement, Immune will fund further development of the product candidate and BioNanoSim will be eligible to potentially receive certain development and regulatory milestones as well as royalties on sales. BioNanoSim is a nanotechnology drug delivery company formed by Professor Simon Benita, and Yissum, the Technology Transfer Company of the Hebrew University of Jerusalem. Immune previously signed a Memorandum of Understanding with Yissum regarding the application of the technology.

 

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