OliX Pharmaceuticals Technology Information No . 1
Indication(적응증)
New drug(신약) (Ingredients)
Any locally applicable disease
IMD(개량신약) (Ingredients)
Biomedicine (Ingredients)
Technology Cell penetrating siRNA
Item description We have a platform technology for cell penetrating asymmetric siRNA (cp-asiRNA) which can be efficiently internalized into cell and can specifically knock-down target gene expression without help of any delivery vehicle such as liposome or polymer. The cpasiRNA showed highly efficient intracellular delivery into hard-to-transfect cells including primary cells and suspension cells. It also showed effective gene silencing in skin, eye, and lung of animal models, and the safety of cp-asiRNA was confirmed in preclinical study. The efficacy and safety in human will be evaluated in Phase I clinical trial by the end of this year. Development status - Therapeutics utilizing cp-asiRNA technology for skin application (OLX101) is in clinical stage. For eye disease and pulmonary disease, it is in preclinical stage. Plans for Out-Licensing or joint R&D or investment We are open to discuss any collaboration opportunities in novel applications including locally applicable disease of which the biological mechanism is clear. The lead candidate can be identified within months by our proprietary RNAi platform technology. Patent (Korean patent number and patent families in US, EU, Japan, China) - KR 10-0949791 (US 12/808,772; EP 08861334.4; JP 2010-539301; CN 200880126981.7; AU 2008339215) - KR 10-1328568 (US 13/880,670; EP20110834541; JP 5795072; CN 201180062076.1; CA 2818662) - KR 10-1567576, KR 10-1581655 (US 14/403,121; EP 13 794 539.0; JP 2015-513901; CN 201380038984.6) 2
Hypertrophic scar
OLX101 (Oligonucleotid e drug)
Item description OLX101 was developed for inhibiting the hypertrophic scar and keloid formation for which there is no approved therapeutics by repressing the expression of CTGF (connective tissue growth factor) protein. Following the preclinical study which is published in Journal of Investigational Dermatology, IND (investigational new drug) was approved by the Korea FDA recently. The phase 1 study will be finished by the end of this year. We are also planning another phase 1 study in Europe which will be started in October this year. Development status - IND approval by Korean FDA (Jan. 2017) - Planning EU clinical trial (Oct. 2017) Plans for Out-Licensing or joint R&D or investment The development of OLX101 in Asia was partnered with Hugel, Korean company, and the commercial right in another territory is remaining in OliX. We are looking for the partners for the development in a certain territory or global development. Patent (Korean patent number and patent families in US, EU, Japan, China) - KR 10-1328568 (US 13/880,670; EP20110834541; JP 5795072; CN 201180062076.1; CA 2818662) - KR 10-1567576, KR 10-1581655 (US 14/403,121; EP 13 794 539.0; JP 2015-513901; CN 201380038984.6) 3
IPF (Idiopathic pulmonary fibrosis)
OLX201 (Oligonucleotid e drug)
Item description OLX 201 is a therapeutic candidate for Idiopathic Pulmonary Fibrosis (IPF), which is a disease of unknown etiology in which lung tissue undergoes severe and progressive scarring (fibrosis). Most patients live only about 3 to 5 years after diagnosis, and the death is mainly due to the respiratory failure. Approximately 70,000 patients in USA and Europe suffer from IPF, and the market across the US and EU is estimated to $1.1 billion in 2017. There are 2 marketed drugs, Pirfenidone and Nintedanib, but the medical unmet needs are still remaining. We are developing an aerosol based IPF therapeutics with the same molecule used in OLX101 program, pre-validated oligonucleotide for anti-fibrosis developed by OliX. Development status - Preclinical study - We are planning phase 1 clinical trial in US in late 2018 Plans for Out-Licensing or joint R&D or investment We are looking for the partners for the development in a certain territory or global development. Patent (Korean patent number and patent families in US, EU, Japan, China) - KR 10-1328568 (US 13/880,670; EP20110834541; JP 5795072; CN 201180062076.1; CA 2818662) - KR 10-1567576, KR 10-1581655 (US 14/403,121; EP 13 794 539.0; JP 2015-513901; CN 201380038984.6)
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AMD (Aged Macular Degeneration)
OLX301A (Oligonucleotid e drug)
Item description OLX301 is a therapeutic candidate for age-related macular degeneration (AMD). AMD is a leading cause of severe vision loss in people over age 60. There are 2 types of AMD, which are wet AMD and dry AMD. The dry (atrophic) type affects approximately 80-90% of individuals with AMD, and the wet (neovascular or exudative) type accounts for 1020%. There are 3 drugs treated for wet AMD, (Lucentis, Eylea, and Avastin), and the global market was about $ 8 billion in 2015. There is no approved treatment or cure for dry AMD. OLX301 showed therapeutic effect in both wet AMD and dry AMD in preclinical study. It is a first-in-class drug of which target is not directly linked in VEGF signaling pathway. Development status - Preclinical study - The preclinical toxicity study is ongoing. We are planning phase 1 clinical trial in US in mid 2018. Plans for Out-Licensing or joint R&D or investment We are looking for the partners for the development in a certain territory or global development. Patent (Korean patent number and patent families in US, EU, Japan, China) - KR 10-1567576 (US 14/403,121; EP 13 794 539.0; JP 2015-513901; CN 201380038984.6) - KR 10-0949791 (US 12/808,772; EP 08861334.4; JP 2010-539301; CN 200880126981.7; AU 2008339215) - US Provisional App. # 62/255,878