December 20, 2014 4:42 PM ET

Pharmaceuticals

Company Overview of Quark Pharmaceuticals, Inc.

Company Overview

Quark Pharmaceuticals, Inc., a clinical-stage pharmaceutical company, engages in the discovery and development of novel RNAi-based therapeutics. Its products include PF-655, a synthetic siRNA to inhibit the expression of proprietary target; QPI-1002, a synthetic siRNA to temporarily inhibit expression of the pro-apoptotic protein, as well as for the prevention of delayed graft function in kidney transplant patients; and QPI-1007, a neuroprotective agent for the treatment of optic neuropathies. The company was formerly known as Quark Biotech, Inc. and changed its name to Quark Pharmaceuticals, Inc. in June 2007. Quark Pharmaceuticals, Inc. was incorporated in 1993 and is headquartered in Frem...

6501 Dumbarton Circle

Fremont, CA 94555

United States

Founded in 1993

97 Employees

Phone:

510-402-4020

Fax:

510-402-4021

Key Executives for Quark Pharmaceuticals, Inc.

Founder
Age: 68
Chief Financial Officer
Chief Operating Officer
Age: 56
Senior Vice President of Strategy & Planning
Age: 62
Chief Medical Officer
Age: 48
Compensation as of Fiscal Year 2014.

Quark Pharmaceuticals, Inc. Key Developments

Quark Pharmaceuticals, Inc. Reports Favorable Results From Phase II Clinical Trial Evaluating Investigational siRNA QPI-1002

Quark Pharmaceuticals, Inc. reported data from a randomized, double-blinded, placebo-controlled multicenter Phase II clinical trial of QPI-1002, a synthetic chemically modified siRNA acting to reduce p53 RNA and protein levels, for the prophylaxis of delayed graft function (DGF) in deceased donor kidney transplant patients. The data were presented in the late-breaking session at the 2014 World Transplant Conference in San Francisco, CA by Dr. V. Ram Peddi, Director of Kidney Transplant Research at California Pacific Medical Center in San Francisco, on behalf of the QPI-1002 DGF Study Investigator Group. The study, which included 331 treated (327 efficacy evaluable) patients, was conducted in 52 transplant centers across North America and Europe. The primary objectives of the study were to assess the efficacy of QPI-1002 in the prevention of DGF and to further assess its safety and pharmacokinetics. The primary study endpoint was to achieve at least 30% relative risk reduction of DGF (defined as the need for dialysis within the first 7 days post-transplant, excluding dialysis in the first 24 hours due to hyperkalemia/hypervolemia) in QPI-1002-treated patients compared to placebo. The overall QPI-1002 safety profile was consistent with the expected profile for transplant recipients, and similar in both treated and placebo groups. While the primary endpoint for the study was not met in the total study population (15.1% relative risk reduction of DGF), the data presented at the WTC showed that treatment with QPI-1002 resulted in 30.5% relative risk reduction in patients included in the largest of the prospectively defined study strata - Expanded Criteria Donor kidneys entirely Cold Stored (ECD/CS, n=177,). The same relative risk reduction of approximately 30% was obtained, in post hoc analysis of the results, in all recipients of kidney grafts from donors older than 45 or 35 years of age, n=252; 77% and n=283; 86% respectively of all efficacy evaluable patients, regardless of the predefined graft strata classification (data for older than 35 not presented at the WTC). Furthermore, in the ECD/CS stratum, QPI-1002 treatment significantly increased the dialysis free survival (time to first dialysis) in the first post-transplant month (Log rank p=0.04), reduced the mean duration of the first course of dialysis (13.4 vs 25.3 days); and reduced the number of dialysis sessions required in the first 30 days post-transplant (6.0 vs 11.2). Similar results were obtained in all recipients of kidney grafts from donors older than 45 and in patients receiving kidneys of donors older than 35 years of age, regardless of the predefined graft strata classification (data for older than 35 not presented at the WTC). By the end of 6-month study observation period, the total number of dialysis sessions in all efficacy evaluable patients treated with QPI-1002 was 1.5-fold lower compared to placebo group (375 vs. 561 p=0.059). The improved outcomes associated with QPI-1002 treatment in the function of kidney grafts from older donors is consistent with recently published studies(1) showing stronger activation of p53, the target of QPI-1002, following reperfusion of older kidneys in animal models. Altogether, the trial findings justify continued development of QPI-1002 for the prevention and amelioration of DGF, an unmet medical need. In addition, increased impact of kidney age on treatment outcomes of QPI-1002 indicates that this drug may be useful for prophylaxis of acute kidney injury in patients undergoing major cardiac surgery given the higher prevalence of this procedure in aging population. Quark believes that QRK.006B is the first ever well-controlled clinical trial involving hundreds of patients in which a systemically administered siRNA-based drug has shown clinical activity. The QRK.006B Phase II study was a multicenter placebo-controlled, randomized, prospective, and double-blinded for evaluating the clinical activity of QPI-1002 (administered as 10 mg/kg single bolus IV dose at 30 minutes after circulatory reperfusion is achieved to the transplanted organ) in end-stage kidney disease dialysis-dependent patients undergoing deceased donor kidney transplantation. The primary objectives of the study were to assess the efficacy of QPI-1002 in the prevention of DGF and to further assess its safety and pharmacokinetics. The incidence of DGF (defined as the need for dialysis within first 7 post-transplant days excluding dialysis in the first 24 hours due to hyperkalemia /hypervolemia) was the primary study endpoint, whereas secondary endpoints included other definitions of DGF, and parameters evaluating DGF severity and kidney function in the post transplant period. The patients were prospectively grouped into 4 strata by the type of donor - expanded or standard criteria donors (ECD or SCD); and graft preservation - cold-stored or machine-perfused with protocol specified cold ischemia time (CIT requirements).

Quark Announces Completion of Phase II Trial Evaluating QPI-1002 for Prevention of Delayed Graft Function in Kidney Transplant Patients

Quark Pharmaceuticals, Inc. reported completion of a randomized, placebo-controlled multicenter Phase II trial of QPI-1002 for the prophylaxis of delayed graft function (DGF) in ESRD dialysis-dependent patients undergoing deceased donor kidney transplantation. The results of the trial will be presented at the 2014 World Transplant Conference in San Francisco, as an oral presentation in the late-breaking session on July 28, 2014. Novartis has an exclusive worldwide license option for the development and commercialization QPI-1002. The study was a placebo-controlled, randomized, prospective, double-blind, multicenter, phase II study of the safety and clinical activity of Quark's siRNA compound QPI-1002, which is the first siRNA compound to be used systemically in human clinical trials. The Phase II trial enrolled 332 patients randomized to receive deceased donor organs, primarily from extended criteria donors (ECD). The study involved 52 centers in the United States, Canada, France, Germany and Spain. The study subjects were randomized 1:1 to receive 10 mg/kg single bolus IV dose of QPI-1002 or placebo at 30 minutes following reperfusion. The primary endpoint was the incidence of DGF, assessed as the incidence of dialysis as defined per protocol (the necessity for dialysis during the first 7 days following the transplantation, with the exclusion of dialysis given due to specific DGF-unrelated reasons that were prospectively defined in the protocol). The secondary end points included a set of parameters measuring other definitions of DGF, dialysis occurrence, duration and severity per patient immediately after transplantation and during the follow up period (up to 6 month post transplant) as well as kidney function parameters.

Biocon Limited Enters into License and Collaboration Agreement with Quark Pharmaceuticals

Biocon Limited and Quark Pharmaceuticals, Inc. have entered into a license and collaboration agreement for the development of siRNA, or small interfering RNA, based novel therapeutics. This collaboration will enable Biocon to co-develop, manufacture & commercialize QPI-1007, a novel siRNA drug candidate for ophthalmic conditions, for India and other key markets. Biocon will have access to Quark's innovative and proprietary siRNA technology platform that can be leveraged for the development of novel therapeutics for various unmet medical needs. QPI-1007 is being developed for ocular neuroprotection in NAION (non- arteritic anterior ischemic optic neuropathy) and acute angle closure glaucoma. An expert team of scientists from Quark and Biocon will jointly work on the development of QPI-1007, and the additional novel pipeline, leveraging the siRNA innovative technology.

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Recent Private Companies Transactions

Type
Date
Target
Private Placement
January 7, 2014
Kunshan RiboQuark Pharmaceutical Technology Co., Ltd.
 

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