Executive Summary

CompleGen is a drug discovery company applying novel genetic technology that makes the discovery of biologically active compounds such as drugs or agricultural products more efficient. Our XenoGene™ system can drastically speed the discovery of compounds that specifically act on a given target and not on others. (A target is a molecule involved in a disease process, a normal process one wishes to affect or a function essential for maintenance of a pathogen.) Our system is based on the replacement of genes of a microorganism that is well characterized and easily grown with functional gene(s) of the target organism or cell, while maintaining the ability to identify compounds that act specifically on the target gene product. The system allows CompleGen and its clients to exploit the massive amount of genomic information gained over the past decade and the thousands of chemical compounds generated by modern synthetic technologies to discover useful products (drugs and other biologically active chemicals).

Functional Gene Discovery—Identification of New Therapeutic Targets

CompleGen's technology uses the power of genetic selection to isolate genes from target organisms so that they replace a function necessary for growth in yeast, indicating that the protein encoded by the foreign gene, XenoGene™, replaced the activity of the yeast protein. CompleGen has discovered, developed and patented a system that makes this process very efficient. We have used this system to identify novel drug targets that are proprietary to CompleGen.

Functional Assays for Selective Drug Discovery

CompleGen addresses two major technical issues in drug discovery, target assay development and selective compound discovery. CompleGen can rapidly establish assays that are very selective. This translates into lower drug discovery cost, reduced time to clinical testing, and more specifically acting compounds with fewer side­effects.

It is estimated that each of the major pharmaceutical companies must introduce five to six major drugs a year to maintain current growth. Currently, the research and development cost for each new drug is about $500 million. A major reason for the high cost of drug discovery and development is that many compounds fail in late stages of development after considerable investment. Failure is usually the result of insufficient specificity, causing unsuitable reactions. Hence, there is a need for the ability to assay many targets and identify compounds that are target­specific. The sequencing of the human genome and subsequent genetic analysis has generated thousands of potential targets for human pharmaceuticals and other biologically active products. Synthetic chemistry technology has provided millions of new compounds. CompleGen provides a technology to use both known and novel targets in the XenoGene™ assay to efficiently identify specifically­acting compounds among the thousands of compounds.

Corporate Development

Phase I CompleGen is marketing its services to the pharmaceutical and agchem industries. We currently offer assays for the discovery of small molecule pharmaceuticals. We provide certain assays on a nonexclusive basis and others on an exclusive basis. We also have identified targets that CompleGen intends to develop for its own account and sell, or partner later stage development with a pharmaceutical partner. The following are some of the achievements of our Phase I program.

  • CompleGen recently established a contract to supply XenoGene™ assays to Berlex Biosciences, a subsidiary of Schering, AG.
  • CompleGen was recently awarded a $100,000 SBIR grant to support the discovery of novel, male­specific, non­hormonal contraceptives. CompleGen has identified several unique targets and will initiate drug discovery later this year. CompleGen has established a collaboration to use animal models in preclinical development studies. The market for contraceptives is over $3 billion. There are no male­specific, non­hormonal pharmaceuticals, however, recent surveys indicate the need and acceptance for such compounds.
  • CompleGen was awarded a second SBIR grant of $300,000 to support the use of its XenoGene™ system to discover compounds that act on infectious parasitic diseases of humans and livestock.

Phase II CompleGen will launch a compound screening capability later this year as part of its Phase II development. The program will support client programs, as well as CompleGen's internal drug discovery programs.

Intellectual Property

A patent covering the basic XenoGene™ technology was issued to CompleGen. Further patent applications covering novel genes and new methodologies will be filed this year.