Lpath, Inc., a biotechnology company, focuses on the discovery and development of lipidomic-based therapeutic antibodies. The company has two product candidates that are in clinical development, and one that is awaiting FDA clearance to initiate a Phase 1 clinical trial. iSONEP iSONEP is the ocular formulation of sonepcizumab, a humanized monoclonal antibody (mAb) against sphingosine-1-phosphate (S1P). Sphingomab is the original mouse version of this monoclonal antibody. iSONEP is administered by intravitreal (inside the eye) injection, and has demonstrated multiple mechanisms of action in ocular models of disease, including anti-angiogenesis, anti-inflammatory, anti-fibrotic and anti-vascular permeability. ASONEP ASONEP is the systemic formulation of sonepcizumab. In 2010, the company completed a Phase 1 clinical trial in which ASONEP was evaluated in very late-stage cancer patients. In that trial, ASONEP was well tolerated at all dose-levels ranging from 1 mg/kg to 24 mg/kg, other than minor infusion-related reactions observed at the highest dose. In 2015, the company announced that its Phase 2a single-agent, open-label study of ASONEP did not meet the primary endpoint of statistically significant progression-free survival in patients with advanced renal cell carcinoma. Lpathomab Lpathomab is a mAb against lysophosphatidic acid (LPA), a bioactive lipid that has been characterized in scientific literature as playing a key role in nerve injury and neuropathic pain. In 2015, the company submitted the Investigational New Drug (IND) application to the FDA to conduct a Phase 1 study of Lpathomab for the treatment of various forms of severe chronic pain. Research Partners The company’s research partners include the M.D. Anderson Cancer Center, the UCLA Brain Injury Research Center, Johns Hopkins University, the Harvard Medical School, the University of Florida College of Medicine, the University of California — San Diego, the French National Centre for Scientific Research, the Center for Eye Research Australia, the University of Melbourne, the Beth Israel Deaconess Medical Center, the Walter Reed Army Institute for Research, the Medical University of South Carolina, the Virginia Commonwealth University, and the University of Kentucky. Strategy With its focus on bioactive lipids as targets for human disease, the company has developed an expertise involving various tools and technologies that positions the company as a leader in the emerging category of lipidomic-based therapeutics. The company intends to leverage this expertise by using its proprietary ImmuneY2 drug-discovery engine to add novel bioactive-lipid-oriented product candidates to its therapeutic pipeline. Research and Development The company’s research and development expenses included $18.1 million in the year 2014. Collaborations Pfizer Inc.: In 2010, the company entered into an agreement providing Pfizer Inc. with an exclusive option for a worldwide license to develop and commercialize iSONEP, the company’s lead monoclonal antibody product candidate, which is being evaluated for the treatment of wet age-related macular degeneration (wet AMD) and other ocular disorders. Intellectual Property In the bioactive-lipid area, the company has with 58 issued patents, including 27 foreign patents, and 102 pending patents, including 77 foreign patent applications. The company’s intellectual-property portfolio includes compositions of matter that specifically bind to sphingolipids and sphingolipid metabolites. These agents, including antibodies, could be used in the diagnosis and treatment of various diseases and disorders, including cardiovascular and cerebrovascular disease, cancer, inflammation, autoimmune disorders, ocular disease, and angiogenesis. Regulations The company is required to submit the results of preclinical tests, together with manufacturing information and analytical data, to the FDA as part of an Investigational New Drug, which must become effective before it begins human clinical trials.
lpath inc-class a (LPTN:NASDAQ CM)
4025 Sorrento Valley Boulevard
San Diego, CA 92121
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