Genitope Corporation announced results of two pre-clinical studies, which demonstrated the proof of concept of the company’s monoclonal antibody program to treat B-cell malignancies such as non-Hodgkin’s lymphoma (NHL).
In these pre-clinical studies, two monoclonal antibodies in development depleted targeted B-cells, without significantly affecting the non-targeted B-cells. The results of these studies were presented at the American Society of Hematology 49th Annual Meeting and Exposition.
“The proof-of-concept studies are important because they suggest that these antibodies have a significant likelihood of working in the clinic,” said Dan W. Denney, Jr., Ph.D., chief executive officer of Genitope. “We see an opportunity to combine the monoclonal antibody panel with our active personalized immunotherapy approach. By doing so, we have the potential to bring safer, effective medicines to non-Hodgkin’s lymphoma patients.”
Results for both studies showed that the number of target B-cells bound by the studied monoclonal antibodies decreased in treated animals, while no significant change was detectable in control animals.
In one study, six animals received eight intravenous infusions of Genitope’s monoclonal antibody; two naïve control animals received infusions of placebo. In a second study evaluating a second monoclonal antibody from Genitope’s panel, 12 animals received four intravenous infusions at various doses; two naïve control animals received infusions of placebo.
Genitope has developed a panel of monoclonal antibodies that bind to different, variable regions expressed on B-cells. Because there are a finite number of variable-region genes that B-cells draw on, it is possible to classify patients with NHL into subsets based on which variable region is used by their particular tumor.
In Genitope’s planned clinical use, once a tumor is biopsied, a simple screening test would be performed to determine which regions are being used by the tumor and identify the group to which the patient belongs. Armed with these results, healthcare professionals could determine which monoclonal antibody from Genitope’s panel would be most effective to target these applicable variable regions. This process allows for the production of monoclonal antibodies that are off-the-shelf while still personalizing the treatment for each patient.
Genitope is also developing its primary product candidate, MyVax® personalized immunotherapy, which is currently in a pivotal, blinded, controlled Phase 3 clinical trial to evaluate its safety and efficacy in previously untreated patients with follicular non-Hodgkin’s lymphoma (fNHL). The treatment phase of this clinical trial has been completed and the protocol-defined follow-up period is scheduled to conclude by the end of this year.
Genitope recently announced the initiation of a Phase 2 clinical trial evaluating the use of MyVax® personalized immunotherapy following primary treatment with rituximab and chemotherapy (R-Chemo) in fNHL patients. Additionally, MyVax® personalized immunotherapy is being evaluated in a Phase 2 clinical trial for the treatment of patients with Chronic Lymphocytic Leukemia (CLL).