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Executive Summary
Carbohydrate mimics ("glycomimetic" compounds) represent an important new class of drugs, and GlycoMimetics, Inc. ("GMI") is positioned to lead this promising field. GMI has a specialized platform technology which is producing first-in-class proprietary drug candidates with an initial focus on inflammation and infectious disease. The Company is achieving key milestones in advancing its programs. The lead program, an acute anti-inflammatory agent, is poised for an IND filing in mid-2008, and GMI has also discovered an exciting pipeline of follow-on opportunities.
GMI's lead anti-inflammatory compound (GMI-1070) inhibits binding of E-, P-, and L-selectins, a key early step in the inflammatory process leading to leukocyte adhesion and recruitment to inflamed tissue. Selectin binding has been shown to be involved in most, if not all, disease processes that involve inflammation. A potent pan-selectin inhibitor would have the potential to address many major market opportunities. GMI is planning to file its first IND in the first half of 2008 to explore the use of GMI-1070 to treat vaso-occlusive crisis of sickle cell disease. This is an indication for which there are no mechanism-based therapies, only supportive symptomatic treatment, and for which there is a significant unmet medical need. The company also plans to explore additional indications that present further opportunities, including atopic dermatitis and graft versus host disease. GMI has extensive data demonstrating the ability of its proprietary compounds to inhibit selectin binding, both in static assays and under conditions simulating blood flow. In addition, several compounds have been tested in animal models where they have been shown to limit inflammatory cell adhesion and migration and to affect other disease-related endpoints.
GMI has also selected a lead in its second program, GMI-1051, which is a compound to be used to treat or prevent infections caused by Pseudomonas aeruginosa. P. aeruginosa is a bacterium responsible for increasing numbers of serious infections which are proving refractory to treatment with antibiotics. This is a critical unmet need in a number of patient populations. Cystic fibrosis patients are chronically colonized by Pseudomonas, and the infection is a major cause of morbidity and mortality in these patients. Pseudomonas is also difficult to treat in other patients, including those who develop pneumonia while on ventilators and those who suffer from burns or from urinary tract infections associated with chronic bladder dysfunction. GMI-1051 inhibits key proteins which are known virulence factors involved in Pseudomonas infectivity and pathogenicity. Specifically, the compound inhibits bacterial adhesion, limits bacterial cytotoxic effects, and appears to enhance clearance of the bacteria. In animal models the compound has been shown to significantly reduce bacterial load and to improve survival. GMI's objective in this program is to develop a drug that would be used in conjunction with antibiotics against chronic infections which have failed to respond to antibiotic treatment alone.
GMI has also identified a third opportunity in a family of high affinity, small molecule E-selectin specific antagonists. The company is exploring this approach to developing drug candidates that could be used acutely or chronically to treat or prevent a variety of conditions involving T-cell migration or endothelial dysfunction. These include inflammatory conditions of the skin and certain vascular complications of diabetes or atherosclerosis.
In several projects at an earlier research stage, GMI is exploring the application of its technology to additional infectious disease targets.
GMI was founded through the acquisition of assets and expertise of a predecessor company, GlycoTech. GlycoTech developed technology to identify and assay carbohydrate mimics initially through a collaboration with Ciba-Geigy (later Novartis), and then independently. In addition, GlycoTech's assay capabilities were contracted to Wyeth over a two year period. Assets acquired from GlycoTech include key intellectual property rights, to which GMI has added substantially since its founding. The company currently owns or has rights to 17 issued U.S. patents as well as additional pending patent applications.
GlycoMimetics has raised a total of $25 million in two rounds of venture financing. The rounds were led by New Enterprise Associates with participation from Alliance Technology Ventures, Anthem Capital, PTV Sciences, the Novartis Venture Fund, and the State of Maryland.
The company's Chief Executive Officer is Rachel King, former CEO of Genetic Therapy, Inc., and former Senior Vice President of Novartis Corporation. GMI's Chief Scientific Officer and Vice President of Research is John Magnani, Ph.D., who founded and led GlycoTech and is a well-known and well-respected leader in the field of glycobiology. The Company's Vice President of Clinical Development is Helen Thackray, MD, FAAP. Dr. Thackray is an experienced biotechnology executive who served as VP of Clinical Development at Biosynexus, Inc. prior to joining GMI.
Rachel King and John Magnani each hold a seat on the Company's Board of Directors, which also includes: M. James Barrett, Ph.D. (Chair), General Partner, New Enterprise Associates; Michael Henos, General Partner, Alliance Technology Ventures; William Gust, General Partner, Anthem Capital; Franklin Top, MD, Senior Vice President of MedImmune Ventures; and John J. Baldwin, Ph.D., President, Vitae Pharmaceuticals and a 33-year veteran of Merck.
Series C Financing Plans
GMI is currently raising its Series C financing, with a goal of financing through a significant value-creating phase. Depending on the amount of financing raised, key target milestones for this phase may include:
* Completion of two Phase 2a studies with GMI-1070, in sickle cell and one other indication;
* Completion of Phase 1 for GMI-1051;
* Lead selection for a chronic anti-inflammatory drug;
* Initiation of a significant corporate partnership.
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Overview of Glycobiology >>
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