Wednesday, February 20, 2019
Exicure, Inc. (OTCQB: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) constructs, and Dermelix Biotherapeutics, a biopharmaceutical company focused on the development of innovative treatments for rare genetic skin diseases, today announced a license and development agreement to advance SNA therapeutics in rare genetic skin diseases. Under the terms of agreement, Dermelix licensed worldwide rights to research, develop, and commercialize Exicure’s technology for the treatment of Netherton Syndrome and up to five additional rare skin indications.
“Late last year we demonstrated the safety and clinical efficacy of our platform in a Phase 1 clinical trial in patients with psoriasis. Building on this success, we are now excited to extend the application of our SNA technology into rare dermatological conditions,” said Dr. David Giljohann, Chief Executive Officer of Exicure. “We look forward to combining Exicure’s ability to design and develop nucleic acid therapeutics with Dermelix’s deep knowledge of the clinical development and regulatory pathways for patients with rare dermatological conditions.”
Dr. Nick France, CEO of Dermelix noted, “Our company was founded to address the lack of innovation within the field of rare dermatological conditions. For too long patients have had few, or in many cases no, available treatment options. We believe the SNA platform will facilitate the rapid development of a portfolio of targeted treatment options for these severely debilitating conditions.”
Dermelix will initially develop a targeted therapy for the treatment of Netherton Syndrome (NS). NS is a rare and severe autosomal recessive disorder caused by loss-of-function mutations in the SPINK5 gene, which encodes the serine protease inhibitor LEKTI involved in skin barrier function. NS affects approximately 1 in 200,000 children born each year, and is characterized by severely inflamed, red, scaled, itchy skin, and patients are at increased risk of mortality in the first year of life due to recurrent infections and dehydration as a result of the impaired skin barrier. Currently, there are no approved treatments for NS patients and off-label use of standard of care treatments are of limited utility.
Under the terms of the agreement, Exicure will receive an upfront payment of $1 million at closing of the transaction and will receive an additional $1 million upon the exercise of each of the five options granted to Dermelix. Exicure will be responsible for conducting the early stage development for each indication up to IND enabling toxicology studies. Dermelix will assume subsequent development, commercial activities and financial responsibility. Exicure is eligible to receive potential payments following the achievement of certain clinical, regulatory, and commercial milestones of approximately $166 million per indication in each of six indications. In addition, Exicure will receive low double-digit royalties on annual net sales for SNA therapeutics developed.