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Drug Names(s): GTOP-99
MYVAX is a personalized cancer vaccine for follicular B-cell NHL and for B-cell NHL. Personalized cancer therapy or personalized immunotherapy implies the use of the patient’s own cells or the patients own unique antigens to activate the immune response.
MYVAX uses the patient’s unique antigen (or sequence of amino acids), present on a cell surface receptor, which happens to be the antibody receptor on malignant B-cells. This unique amino acid sequence present within the antigen-binding site of the antibody is called an idiotype. Each B-cell clone has a unique amino acid sequence with the antigen binding domain of the antibody that is called the idiotype. In B-cell NHL, a clone of antibody producing malignant B-cells with same idiotype is the culprit, and mounting an immune response against that idiotype present on the malignant B-cell population may be an effective mode of therapy.
Generating an effective immune response requires more than just a target antigen. MYVAX is administered along with an adjuvant and a carrier protein. The adjuvant is GM-CSF (granulocyte macrophage-colony stimulating factor), which is a cytokine that stimulates immune cells. The carrier protein administered with MYVAX is KLH (Keyhole Limpet Hemocyanin). The carrier protein is also important in stimulating the immune response and acts a vehicle for the unique idiotype antigen.
This type of active, personalized immunotherapy has been studied in clinical settings for over a decade; however, none has made it to market.
Several steps must take place before the patient is administered the vaccine. The patient’s tumor cells have to be harvested after a biopsy, the genetic sequence for the idiotype has to be determined, and the gene sequence is then inserted in an expression vector, followed by production of a cell line expressing that idiotype protein. The cell line has to be expanded, and then the vaccine has to be formulated before administration. These events may take several weeks. The manufacturing can be divided into two major phases, as describes below:
Molecular Biology Phase
Acquire Tumor cells from patient biopsy à Identify Tumor associated genes à Prepare Expression vector
Cell Culture and Production Phase
Generate Production cell line à Expand Cell line and purify tumor derived Ab à Formulate immunotherapyà Immunize patient
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