Businessweek

Lpath, Inc., a biotechnology company, focuses on the discovery and development of lipidomic-based therapeutics, an emerging field of medical science that targets bioactive signaling lipids to treat a range of human diseases. Product Candidates The company has two product candidates that are in clinical development, and one in pre-clinical evaluation. iSONEP iSONEP is the ocular formulation of sonepcizumab, a humanized monoclonal antibody (mAb) against sphingosine-1-phosphate (S1P) formulated for treating retinal diseases. Sphingomab is the original mouse version of this monoclonal antibody. iSONEP is administered by intravitreal injection, and has demonstrated multiple mechanisms of action in ocular models of disease, including anti-angiogenesis, anti-inflammatory, anti-fibrotic, and anti-vascular permeability. The company has completed a Phase 1 clinical trial in which iSONEP was evaluated in patients with wet age-related macular degeneration (wet AMD). The company has entered into an agreement providing Pfizer Inc. with an option for a worldwide license to develop and commercialize iSONEP. A Phase 1b/2a clinical trial of iSONEP in patients with retinal pigment epithelium detachment (PED), a persistent complication in patients with the occult form of wet AMD is on clinical hold. A Phase 2a clinical trial, to test iSONEP as a treatment for wet-AMD in a broader population of patients, namely, those wet-AMD patients without PED is on clinical hold. ASONEP ASONEP is the systemic formulation of sonepcizumab. The company has completed a Phase 1 clinical trial in which ASONEP was evaluated in very late-stage cancer patients. ASONEP, a formulation of the S1P-targeted antibody, is intended for the treatment of cancer and multiple sclerosis. Lpathomab Lpathomab is an antibody against lysophosphatidic acid (LPA), a key bioactive lipid that has been recognized as a valid disease target. Lpathomab is in pre-clinical testing in various animal models of disease relating to the central nervous system and to fibrosis. Partners The company’s research partners include the M.D. Anderson Cancer Center; Johns Hopkins University; Harvard Medical School, the University of Florida College of Medicine; San Diego State University; the French National Centre for Scientific Research; and the University of Melbourne, Australia. In-licensed Technology Lonza Biologics PLC (Lonza): The company has entered into two licensing arrangements with Lonza. In the first agreement granted the company a non-exclusive license to use cell-line development technology owned by Lonza for research purposes. Under the terms of the second license from Lonza, Lonza granted it a non-exclusive license with rights to use, and to authorize sublicenses to use, Lonza's cell-line technology for the production of drug material to be used in human clinical trials, as well as for commercial sale. AERES Biomedical Limited (AERES): The company has entered into a collaboration agreement with AERES to ‘humanize’ the company's Sphingomab monoclonal antibody. Patents and Proprietary Rights The company’s patent portfolio includes approximately 50 issued or pending patents in the United States, with corresponding applications in major foreign countries. Government Regulation The company is required to submit the results of its preclinical tests, together with manufacturing information and analytical data, to the U.S. Food and Drug Administration as part of an Investigational New Drug Application, which must become effective before the company may begin human clinical trials. History Lpath, Inc. was founded in 1997.