Sponsor: CytImmune Sciences, Inc.

• Project duration: 10/1/2004 - 9/30/2007
• Total project (est.): $2,879,056
• Requested ATP funds: $1,999,972

Nearly one in four new therapeutic drugs entering clinical trials are monoclonal antibodies, a $1-billion industry and growing. The popularity of monoclonal antibodies is due to their specificity: they can be tailored to target specific tumors, organs, and circulating molecules to fight diseases such as cancer and rheumatoid arthritis. On the downside, these antibodies currently are made in mice and therefore set off species-specific immune responses in human patients. Efforts to make wholly human monoclonal antibodies to date have met with only limited success. CytImmune Sciences Inc. plans to develop a semi-synthetic human immune system in vitro using colloidal gold nanoparticles, to make wholly human monoclonal antibodies in a simple and reproducible way. Colloidal gold - tiny gold particles suspended in a solution - already is used as a drug delivery system. The nanoparticles can carry therapeutic molecules on their surfaces and can be modified to prevent detection by the immune system. Researchers can also control particle size and 3D spatial orientation to stimulate the human immune system. CytImmune has a two-part strategy for activating human B cells, the specialized immune cells that make antibodies, in vitro to ultimately produce monoclonal antibodies. The company plans to bind multiple chemical species - antigens and accessory molecules that help regulate B-cell activation and antibody production - to the surface of self-assembling gold nanoparticles, using strategies developed previously in drug development. The company will use gold nanoparticles to promote maturation of the B-cell antibody response. Once B cells produce antibodies with the desired activity, they will be fused with specially-selected tumor cells from an existing cell bank that can replicate endlessly to make an "antibody factory." ATP funding is needed because other potential investors are skeptical of efforts to develop wholly human monoclonal antibodies, and because pharmaceutical companies will not invest in approaches that compete with their own. CytImmune plans to develop antibodies against tumor necrosis factor to treat rheumatoid arthritis. The condition afflicts 2.1 million Americans and costs $12 - $20 billion annually in medical costs and lost work. In addition to reducing the costs of arthritis, the wholly human antibodies also may help treat other diseases such as other autoimmune diseases, cancer and AIDS. If successful, the project could reduce development costs by $600 million per antibody-based drug and reduce drug costs and side effects for consumers.

For project information:

Lawrence Tamarkin, Ph.D., (240) 864-2796
ltamarkin@cytimmune.com

ATP Project Manager

Michael Amos, 301-975-8631
michael.amos@nist.gov

This is the fact sheet for this project as it was announced on September 28, 2004.
Click here for the latest version of this fact sheet.
Visit the Advanced Technology Program Home Page