BIOWA, MEDAREX APPROVED TO BEGIN TRIAL OF ANTI-CD30 ANTIBODY

BioWa and Medarex have received FDA approval for their investigational new drug application for MDX-1401, a fully human antibody that targets CD30-positive lymphomas. MDX-1401 is enhanced for greater Fc-receptor-mediated antibody activity, one critical mechanism in tumor lysis by antibodies, using BioWa's Potelligent Technology.

The dose-escalation, multidose, Phase I clinical trial is expected to enroll up to 36 patients with relapsed or refractory Hodgkin's disease. The trial is designed to establish and evaluate the safety profile and initial efficacy of MDX-1401. Preclinical in vitro studies showed that this second-generation nonfucosylated anti-CD30 antibody demonstrated enhanced antibody-dependent cellular cytotoxicity, an important mechanism of action of therapeutic antibodies, and was active in inhibiting tumor growth in in vivo xenograft models.

Antibody-dependent cellular cytotoxicity activity is an important function of the human immune system, whereby immune cells can kill cancer cells. Antibody-dependent cellular cytotoxicity activity is one important mechanism underlying the efficacy of some currently approved anti-cancer antibodies. Enhancement of this activity is in the spotlight as one promising possibility for the next generation of antibody technology.

Potelligent Technology involves the reduction of the amount of fucose in the carbohydrate structure of an antibody. Research shows that Potelligent Technology significantly enhances binding affinity of antibodies for Fc receptors and increases antibody-dependent cellular cytotoxicity activity in vitro. One potential benefit of Potelligent-derived therapeutic antibodies is greater tumor-cell-killing activity than with conventional antibodies.