GlycoMimetics (GMI), based in Gaithersburg, MD, was founded via the acquisition of assets and expertise from GlycoTech, who developed technology to identify and assay carbohydrate mimics initially through a collaboration with Ciba-Geigy, now Novartis (NYSE: NVS), and then independently. These assay capabilities were out-licensed to Wyeth, now Pfizer (NYSE: PFE). Today, GMI holds or has rights to 17 issued patents and a pipeline of patent applications.

Carbohydrate mimics (“glycomimetic” compounds) represent a potential new class of drugs. GMI is developing first-in-class candidates with an initial focus on inflammation, cancer, and infectious disease. The lead compound, an acute anti-inflammatory agent, recently completed Phase I trials.

PRODUCTS IN DEVELOPMENT

GMI1070 (Granted Orphan Drug status by FDA in 2009; Completed Phase I) is a synthetic glycomimetic molecule rationally designed to inhibit all three selectin types (a pan-selectin inhibitor). Selectins are glycoprotein cell adhesion molecules implicated in inflammatory processes, inhibition of all three selectin types (E-selectin, L-selectin and P-selectin) may be required for adequate therapeutic activity in certain inflammatory disorders. There may be a basket of potential applications for GMI1070, including hematologic cancers in which selectins may play a significant role. Selectin-mediated cell adhesion may result in chemotherapy resistance. Selectins have also been shown to facilitate dissemination of cancer cells to bone marrow. The Company is currently evaluating the potential to utilize GMI1070 in combination with chemotherapy.

GMI1051 (Pre-clinical) is a proprietary, small molecular weight compound for the treatment or prevention of infections caused by Pseudomonas aeruginosa, a bacterium responsible for an increasing number of infections which are frequently refractory to treatment with antibiotics. P. aeruginosa is an opportunistic pathogen that is normally non-infective in the growing, though once stimulated, begin to express virulence factors and toxins. Two of these virulence factors are the lectins, PA-IL and PA-IIL. GMI1051 strongly inhibits the functions of both PA-IL and PA-IIL lectins in a wide range of in vitro preclinical tests.

INDICATIONS & MARKETS PURSUED

  • The Company has selected vaso-occlusive crisis of sickle cell disease as the first indication to explore with GMI1070. Inflammation is a key mediator of vaso-occlusive crisis, a condition which represents a significant unmet medical need. Sickle cell disease is one of the most prevalent genetic disorders in the US, affecting over 80,000 people. It is a chronic condition with substantial morbidity and mortality, responsible for more than 75,000 hospitalizations per year in the US with an average stay of approximately 6 days.
  • Pseudomonas aeruginosa is the second-leading cause of nosocomial infections, which are mainly acquired in intensive care units, and affects primarily patients who require mechanical ventilation. Infections of the heart, central nervous system, respiratory system, skin and soft tissue are common. One of the most worrisome characteristics of P. aeruginosa consists in its low antibiotic susceptibility. This low susceptibility is attributable to a concerted action of multidrug efflux pumps with chromosomally-encoded antibiotic resistance genes (e.g. mexAB-oprM, mexXY etc.) and the low permeability of the bacterial cellular envelopes. Besides intrinsic resistance, P. aeruginosa easily develop acquired resistance either by mutation in chromosomally-encoded genes, or by the horizontal gene transfer of antibiotic resistance determinants. Development of multidrug resistance by P. aeruginosa isolates requires several different genetic events that include acquisition of different mutations and/or horizontal transfer of antibiotic resistance genes. Hospital-acquired infections are one of the major causes of death and serious illness worldwide, resulting in an annual cost burden of more than $20 Billion in the developed world. In the United States and Europe about 4 million patients become infected annually resulting in 200,000 deaths per year. The incidence of nosocomial infections is steadily increasing.

FINANCING (to-date ~$63M)

Founded in 2003 GMI closed its first institutional Series A financing totaling $9.6M with participation from Alliance Technology Ventures, Anthem Capital Management, Novartis Venture Funds, PTV Sciences and Maryland Department of Business and Economic Development. Post acquisition of GlycoTech assets, GMI closed a $15.4M Series B financing in 2006 with new participation from New Enterprise Associates and original investors. The latest Series C round, announced in October 2009, totals $38M adding Genzyme Ventures as the sole new investor alongside previous investors.

The Company’s intended use-of-proceeds will be used to fund a Phase II trial ofGMI’s lead drug candidate GMI1070 in vaso-occlusive crisis of sickle cell disease. The company also intends to use proceeds to fund a Phase II study of GMI1070 in a second unannounced clinical indication.

GlycoMimetics