MabVax Approach

The MabVax approach is designed to overcome the problems leading to the high attrition rate in the development of anti-cancer therapeutics by relying on the following:

1. The antigenic targets identified are those that are most extensively expressed on the cell surface of certain types of cancer; primarily gangliosides and other carbohydrate antigens that are minimally expressed on normal tissues. These are not the targets of other competing therapies.
 
2. Positive clinical responses have been demonstrated in already completed Phase I clinical trials with the monovalent vaccines. Additional Phase I and Phase II clinical trials with murine monoclonal antibodies against two of the antigens incorporated in these monovalent vaccines have also resulted in positive clinical responses.
 
3. High titer antibodies against each antigen have been induced by all of the monovalent vaccines in cancer patients in past Phase I clinical trial with minimal toxicity. These trials demonstrate the likelihood that monoclonal antibodies against these targets will cause minimal toxicity while eliciting therapeutically useful antibodies.
 
4. The antibody discovery effort begins with lymphocytes from successfully vaccinated donors so the initial antibody generation and selection process takes place entirely in the human. Based on previous experience, the high titer antibodies that emerge carry high specificity and affinity for the target and minimal cross reactivity with normal autoantigens.
 
5. These antigens are known to be useful targets for immune attack by antibodies induced by these vaccines. The IgG1 and IgG3 antibody subclasses elicited are potent activators of complement and antibody dependent cell mediated cytotoxicity.
 
6. The vaccine preparations will be developed as polyvalent vaccines to address the problem of antigen heterogeneity. The antibody preparations will be developed as multiple monoclonal antibody products or polyvalent antibody mixtures to address the same problem. The antibody preparations can also function as complementary component therapy to the polyvalent vaccine to address the potential problem of incomplete vaccine responses by some patients.