Company Overview of Quark Pharmaceuticals, Inc.
Quark Pharmaceuticals, Inc., a clinical-stage pharmaceutical company, engages in the discovery and development of novel RNAi-based therapeutics. The company offers QPI-1002, a synthetic chemically modified siRNA to reduce p53 RNA and protein levels; QPI-1007, a neuro-protective agent for the treatment of optic neuropathies that results in the death of retinal ganglion cells; and PF-655 for the treatment of diabetic macular edema and the other in patients with wet and age-related macular degeneration. It also provides preclinical pipeline targeting unmet medical needs. Quark Pharmaceuticals, Inc. has discovery and development collaboration with Transplant Genomics Inc. The company was formerl...
6501 Dumbarton Circle
Fremont, CA 94555
Founded in 1993
Key Executives for Quark Pharmaceuticals, Inc.
Founder, Chief Executive Officer, President, Director and Member of Compensation Committee
Senior Vice President of Strategy & Planning
Compensation as of Fiscal Year 2016.
Quark Pharmaceuticals, Inc. Key Developments
Biocon Limited and Quark Pharmaceuticals, Inc. Announce Initiation of Pivotal Phase II/III Study of QPI-1007 in Rare Eye Disease in India
Jun 23 16
Biocon Limited and Quark Pharmaceuticals, Inc. announced the randomization of the first patient in India in the pivotal global Phase II/III study of QPI-1007, a novel siRNA (small interfering RNA) drug candidate for ocular neuroprotection. Biocon and its partner, Quark Pharmaceuticals, have received approval from the Drug Controller General of India (DCGI) to proceed with the study, the first ever clinical trial of a siRNA therapy in India. The QRK207 study will determine the effect of QPI-1007 on visual function in subjects with acute non-arteritic ischemic optic neuropathy (NAION), which is a rare ocular disorder with an unmet need globally. This is part of a global Phase II/III study run by Quark in collaboration with 'Neuro-Ophthalmology Research Disease Investigator Consortium' (NORDIC) and is already enrolling in the US and a number of other countries. RNA interference (RNAi) is a universal mechanism within living cells that employs non-coding RNA to control which genes are active and how active they are. Various types of short double-stranded RNAs act as effector molecules of the RNAi mechanism. Some of them, targeting specific genes in a sequence-dependent manner and inhibiting their expression, are called short interfering RNAs (siRNAs). siRNAs can be designed based on the sequence information of virtually any gene, produced synthetically and used as drugs. siRNA drugs can cause inhibition of expression of any gene, regardless of its traditional attribution to potentially 'druggable' or 'non-druggable' targets. These drugs are highly specific and potentially safer than small molecule therapies which are known to exhibit some degree of promiscuity. Quark's siRNA platform includes proprietary siRNA compound structures and chemical modifications with improved pharmacological properties, while the company's strong IP portfolio provides freedom to operate in the siRNA space. QPI-1007 is a double stranded RNA molecule chemically modified by Quark's proprietary technology. The drug is designed to temporarily inhibit the expression of caspase 2 and thereby block the apoptotic death of retinal ganglion cells. QPI-1007 is being developed as a neuroprotectant for the treatment of NAION and in the future other optic neuropathies such as glaucoma that result in the death of retinal ganglion cells (RGCs). QPI-1007 has been evaluated in a human, dose escalation, Phase I/IIa Study (Protocol QRK007), delivered by single intravitreal injection to Optic Nerve Atrophy patients with low visual acuity and thereafter in acute NAION patients. This study was conducted at 22 sites in the US and 6 sites in Israel. This study showed that a single intravitreal injection of QPI-1007 was well tolerated in subjects with long-standing low vision or acute NAION. The drug has also demonstrated protective activity compared to historical data. QPI-1007 was also studied in a Phase IIa clinical trial in acute angle closure glaucoma patients in the United States, Vietnam and Singapore. This study is a pivotal Phase II/III, randomized, double masked, sham-controlled trial of QPI-1007 delivered by multi-dose intravitreal injections to subjects with acute non-arteritic anterior ischemic optic neuropathy (NAION) to compare the safety and efficacy of two doses of QPI-1007 along with the sham group. This multi-national, multi-centric trial is being conducted across 95 hospitals in several countries including India, US, Israel, Germany, Australia, Italy and China. Approximately 465 patients will be enrolled globally. The treatment for each patient will be 12 months.
Transplant Genomics Inc. and Quark Pharmaceuticals, Inc. Announce Discovery and Development Collaboration
Apr 14 16
Transplant Genomics Inc. ("TGI") and Quark Pharmaceuticals, Inc. ("Quark") announced their joint intent to pursue a discovery and development collaboration involving the use of TGI's TruGraf™ blood test in a Phase 3 clinical trial involving patients being treated for delayed graft function (DGF) with Quark's proprietary drug candidate QPI-1002. Under the agreement, TGI would be Quark's preferred provider of gene expression profiling services related to their clinical trial. The primary objective of the Quark/TGI collaboration will be to understand individual patient responses to QPI-1002 as a function of time and gene expression in pathways of immune response injury post transplant. Results can be correlated with the extensive pre-clinical data created by Quark on the therapy's molecular mechanism. The secondary objective will be to explore potential surrogate endpoints using the possible predictive value of genomic profiling for longer term outcomes post transplant.
Quark Pharmaceuticals Doses First Patients in Two Pivotal Phase III Studies and One Phase II Study of RNAi-Based Therapeutics for Kidney and Eye Indications
Mar 14 16
Quark Pharmaceuticals Inc. announced that in the last month it has dosed the first patients in each of two pivotal Phase III studies – one for prevention and amelioration of the severity of Delayed Graft Function (DGF) in kidney transplant patients and the other for the preservation of visual acuity in Acute Nonarteritic Ischemic Optical Neuropathy (NAION). In addition Quark said it started dosing in a Phase II study for the prevention of Acute Kidney Injury (AKI) in patients undergoing major cardiovascular surgery. Delayed Graft Function (DGF)Study with QPI-1002: Based on the large ever Phase II Study (326 subjects) conducted by Quark, the company met with FDA and EMA and reached agreement on the study design and endpoint for this confirmatory study. The study involves approximately 75 hospitals in North America, Latin America, Australia and Europe. Quark has received Orphan Drug status by the FDA and the EMA for this indication. Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) Study with QPI-1007: The pivotal Phase II/III study is being conducted at approximately 66 hospitals in the U.S., Europe, Israel, India and China. The approval for this study by the Indian (DCGI) and Chinese (CFDA) health authorities marks a major milestone because it is the first time that an siRNA molecule was approved by these authorities to be used in humans in clinical studies. Quark received Orphan Drug status from the FDA on this indication. The siRNA drug molecule is based on Quark's unique new proprietary structure. Acute Kidney Injury (AKI) Study with QPI-1002: The Phase II study is taking place at approximately 40 hospitals in North America. QPI-1002 was the first-ever siRNA molecule dosed systemically in clinical studies under an FDA Investigational New Drug Application.
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