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studies showed the safety of this approach, with side effects mainly limited to local
reactions at the site of the vaccine injection. Immunogenicity of tumor cell vaccines
can be improved by transducing the tumor cell with genes that encode key compo-
nents of the immune response, e.g. cytokines such as granulocyte-macrophage col-
ony stimulating factor (GM-CSF) and costimulatory molecules.
Most of the cancer vaccines are being developed in the commercial sector. Whole
tumor vaccines have gone through clinical trials. None of the tumor cell vaccines
are in the market in the US.
FANG Vaccine
The FANG™ vaccine (Gradalis Inc) is an autologous tumor-based product incorpo-
rating a plasmid expressing a well-established immune activator, GM-CSF and a
novel bifunctional short hairpin RNAi (bi-shRNAi) targeting furin convertase,
thereby downregulating endogenous immunosuppressive TGF β1 and β2. It is man-
ufactured from a cell suspension derived from a portion of a patient’s tumor removed
during surgery. bi-shRNAi is introduced into the cells by electroporation. Cells are
then incubated overnight, irradiated, frozen, tested and released. Vaccine is shipped
to the patient’s clinic where doses are thawed and administered monthly by intrader-
mal injection. FANG manufacturing is a straightforward 2-day cGMP process that
is applicable to nearly all tumor types with no modifi cation, and it does not require
patients to undergo apheresis or other treatments except surgical tumor removal if
indicated.
Results of a phase I study showed that treatment with FANG was safe and signifi -
cantly increased survival in patients with advanced stage cancer compared to
patients who received other forms of treatment (Senzer et al. 2012 ). The vaccine
elicits a robust and lasting immune response, resulting in statistically-signifi cant
prolonged survival in patients with advanced stage disease. Currently, FANG is
being evaluated in several phase II trials in patients with advanced ovarian cancer,
advanced melanoma and advanced colorectal cancer with liver metastases. In addi-
tion, Gradalis has initiated a clinical program evaluating FANG in children with
Ewing’s sarcoma.
MyVax
MyVax ® (Genitope Corporation) is an investigational treatment based on the unique
genetic makeup of a patient’s tumor and is designed to activate a patient’s immune
system to identify and attack cancer cells. It combines a protein derived from the
patient’s own tumor with an immunologic carrier protein and is administered with
an immunologic adjuvant. Development of this immunotherapeutic approach has
been limited by manufacturing diffi culties. Genitope has developed a proprietary
manufacturing process that overcomes many of these historical manufacturing limi-
tations. A phase II trial found that immunization of follicular lymphoma patients
10 Personalized Therapy of Cancer