Great news just for patients and HGSI arrived in my mailbox in the form of this week’s New England Journal of Medicine. The lead article is a report of the Phase III trial results of a monoclonal antibody treatment for a certain type of malignant breast cancer. This positive result validates HGSI’s model for the development of many of their drug candidates.
First, the trial: (Genentech’s name is all over the notes, so I assume it is their drug.) There is a growth factor receptor gene called human epidermal growth factor receptor (HER2). In about one-quarter of the cases of women with breast cancer, the encoded protein is present in extremely high levels in the cancer cells and is associated with a more aggressive form of cancer. Thus, the unfortunate women with this form of the disease respond poorly to chemotherapy and succumb at a higher rate than women without the “over-expression” of HER2. A monoclonal antibody was developed against the protein, with the hope that the antibody could be effective in treating the cancer. The trial protocol called for one group to get the standard chemotherapy, while the other group received the standard chemotherapy plus the monoclonal antibody. The results were excellent, with the addition of the antibody being associated with a longer time to disease progression, a longer duration of response, a lower death rate at 1 year and a longer survival. All of these results reached statistical significance at the .05 level. Obviously, this study is good news for patients with a certain type of breast cancer.
This study validates the heart of HGSI’s approach to therapeutics. As I have stated many times in the past, the majority of medications that HGSI will produce may not be the protein product of the gene itself, but rather the antibody to the protein that is elevated in a disease state. In this instance, breast cancer cells vastly overproduce a normally-occuring protein. An antibody is produced against the “normal” protein and given to patients resulting in an efficacious therapy. A good example of an HGSI monoclonal antibody is anti-BLyS. BlyS will be used for immune deficiency diseases, but perhaps more importantly, anti-BLyS may be used in inflammatory conditions of “too much” BLyS, such as inflammatory arthritis. HGSI had the foresight to recognize the importance of monoclonal antibodies directed against its catalog of proteins and has forged partnerships with antibody companies as well as expanded in-house facilities to focus on antibody therapy. |
