Method for making a homogenous vaccine composition comprising a conjugate of EGF and 64K for the treatment of tumors

摘要

A vaccine composition for therapeutic use thereof on cancer patients includes a chemical conjugate of human recombining Epidermic Growth Factor (hrEGF) and a combining protein P64k for performing a conjugation reaction which produces said chemical conjugate in a controlled and reproducible manner. The preferred conjugate surprisingly increases the immunogenic activity causing significant increases in the anti-EGF antibody titers in humans, and provides a vaccine preparation with more than one type of effective dose presentation which enables the immunization dose per patient to be increased, but without involving an increase in immunization frequency and/or the number of immunization sites.

主权项

1. A method for making a vaccine composition for treating lung cancer, said method comprising: ultrafiltrating a conjugated hrEGF-rP64K protein, wherein after ultrafiltration a homogeneous mix of the conjugated hrEGF-rP64K protein is obtained, and wherein each rP64K carrier protein molecule is bound to two hrEGF molecules, the conjugation ratio between the rP64K carrier and the hrEGF protein is 12.04:24.05, the total protein is in the range of 1-12 mg/mL and constitutes more than 90% of the total area of a chromatogram.