FREMONT, Calif., Oct. 9, 2017 Quark Pharmaceuticals, Inc., a late clinical-stage pharmaceutical company and leader in the discovery and development of novel RNAi-based therapeutics for unmet medical needs, is delivering an oral presentation at the 6th Annual RNAi China Conference in Jiangsu.
The presentation will summarize the preclinical efficacy data for inhaled small interfering RNA (siRNA) against an undisclosed target gene on preventing primary graft dysfunction and acute rejection in an animal model of lung transplantation.
The asset is being developed in collaboration with Biocon, Asia’s leading biopharmaceutical company. The pre-clinical efficacy proof-of-concept and pharmacodynamic studies were conducted by the group of scientists led by Professor Andrew Gelman from Department of Surgery at the Washington University School of Medicine, St. Louis, Missouri and by Quark’s scientific team, with collaboration of Biocon’s scientists. The presentation will be delivered by Dr. Swetlana Adamsky, Quark’s Senior Director of Translational Research on October 10, during the first morning session.
“Quark’s proprietary siRNA is distributed throughout the lungs of small and large animals after airway delivery and leads to a dose-specific target knockdown in both inflammatory and resident lung cells. In the mouse model of lung transplantation, post-transplantation airway delivery of siRNA significantly and substantially reduced graft edema and infiltration of both innate and adaptive immune cells thus improving the graft aeration and significantly reducing the signs of acute graft failure and rejection,” stated Dr. Adamsky.
Quark’s Chairman and CEO Dr. Daniel Zurr said: “While siRNA studies have traditionally focused on the liver, Quark continues to produce non-clinical and clinical research data demonstrating that siRNA can be effectively delivered to other organs and tissues. Quark is moving its siRNA therapeutics into the mainstream for multiple extrahepatic disease indications. Most importantly, Quark is focusing on critical unmet medical needs of which primary graft dysfunction following lung transplantation is one of them.”
Dr. Narendra Chirmule, Sr. Vice President & Head of R&D at Biocon, said: “We are extremely proud of our teams for advancing this high potential novel asset toward clinical development phase with robust preclinical efficacy data generated for the prevention of primary graft dysfunction in lung transplant patients. As the first biopharma company in India to have forayed into the siRNA-based therapeutics, in collaboration with Quark Pharmaceuticals, we are extremely excited to progress this cutting-edge therapy.”
Quark and Biocon Ltd., have a licensing and collaboration agreement to develop siRNA therapeutics for prevention of primary graft dysfunction following lung transplantation. In addition to this program, Quark has licensed QPI-1007, a siRNA drug candidate for ocular neuroprotection, to Biocon for India and for other Asian markets. QPI-1007 is in a global Phase 2/3 study for patients with non-arteritic anterior ischemic optic neuropathy, or NAION, and is the first siRNA to be approved for dosing in humans by India’s regulatory authorities.
About Primary Graft Dysfunction Following Lung Transplantation
Lung transplantation is a definitive therapy for many end-stage lung diseases. Primary graft dysfunction (PGD) affects up to 30% of recipients and is a leading cause of early morbidity and death in the lung transplant patients. Being a form of Acute Respiratory Distress Syndrome (ARDS), PGD shares a number of pathological pulmonary features (such as e.g., increased permeability as reflected by alveolar edema, and neutrophil infiltration) with ARDS of other etiologies. The drug may be, therefore of potential utility in further conditions associated with ARDS for which the effective therapies are still lacking and supportive therapies remaining the mainstay in the ARDS management. The incidence of ARDS is estimated at 190,000 cases per year in the US with a mortality of approximately 40%.
About Quark Pharmaceuticals, Inc.
Quark Pharmaceuticals, Inc. is a world leader in discovery and development of novel small interfering RNA, or siRNA, therapeutics for unmet medical needs. RNA interference is a biological process in which RNA molecules regulate expression of targeted genes. Quark’s fully integrated drug discovery and development platform spans the process from therapeutic target identification to drug development. Two products, QPI-1002 for delayed graft function (DGF) following kidney transplantation and QPI -1007 for non-arteritic ischemic optic neuropathy (NAION), have been granted orphan designation and are in global Phase 2/3 pivotal clinical studies. Quark’s broad pipeline of clinical and preclinical product candidates is generated from the company’s internally-developed siRNAi platform technology and focuses on extrahepatic indications. In July this year, Quark has successfully completed a randomized double-blinded Phase 2 trial exploring efficacy of QPI-1002 in prevention of acute kidney injury (AKI) following cardiac surgery that met the primary and multiple secondary endpoints. Novartis has an option to license this product. Another Quark siRNA pipeline drug, PF-655, is licensed to Pfizer. Quark is headquartered in Fremont, California and operates research facilities in Ness-Ziona, Israel. For additional information please visit: www.quarkpharma.com.
About Biocon Ltd.
Biocon LTD publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India’s largest and fully-integrated, innovation-led biopharmaceutical company. As an emerging global biopharmaceutical enterprise serving customers in over 120 countries, it is committed to reduce therapy costs of chronic diseases like diabetes, cancer and autoimmune. Through innovative products and research services it is enabling access to affordable healthcare for patients, partners and healthcare systems across the globe. It has successfully developed and taken a range of novel biologics, biosimilars, differentiated small molecules and affordable recombinant human insulin and analogs from ‘Lab to Market’. Some of its key brands are INSUGEN® (rh-insulin), BASALOG® (Insulin Glargine), CANMAb™ (Trastuzumab), BIOMAb-EGFR™ (Nimotuzumab) and ALZUMAb™ (Itolizumab), and a ‘first in class’ anti-CD6 monoclonal antibody. It has a rich pipeline of biosimilars and novel biologics at various stages of development including Insulin Tregopil, a high potential oral insulin analog.