Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine
design, development and delivery, announced today additional interim
safety and immunogenicity data from its therapeutic cervical cancer
vaccine (VGX-3100) trial. VGX-3100 is a DNA vaccine targeting the E6 and
E7 proteins of human papillomavirus (HPV) types 16 and 18 and is
delivered via in vivo electroporation. Similar to previously
reported data from the initial lowest dose cohort of this phase I trial,
the vaccine was found to be generally safe and well tolerated. While
previously reported data showed significant cellular and humoral immune
responses, data from this second, intermediate dose group highlighted a
significantly increased and dose-related immune response specific to the
antigens targeted by the vaccine.
“We are extremely pleased with the safety and tolerability profile of
VGX-3100. Furthermore, analyses of the vaccinated subjects from the
first two cohorts indicate that this vaccine is highly immunogenic,
generating antigen-specific T-cell and antibody responses that are
amongst the highest reported from any previous human studies of DNA
vaccines”
“We are extremely pleased with the safety and tolerability profile of
VGX-3100. Furthermore, analyses of the vaccinated subjects from the
first two cohorts indicate that this vaccine is highly immunogenic,
generating antigen-specific T-cell and antibody responses that are
amongst the highest reported from any previous human studies of DNA
vaccines,” stated Dr. J. Joseph Kim, President and CEO.
“While recent HPV preventive vaccines have been successful in protecting
against infections that may lead to cervical cancer, Inovio’s
therapeutic vaccine targets the millions of women already infected with
HPV and is intended to treat pre-cancerous cells and cervical cancer
caused by this virus. Current vaccines do not serve this group of
women,” Dr. Kim added.
This dose escalation study was designed to test the safety and
immunogenicity of VGX-3100 in women with a previous history of cervical
intraepithelial neoplasia (CIN) 2/3, a precursor lesion prior to the
development of cancer. The trial is enrolling patients in three cohorts
of six subjects each with DNA vaccine doses at 0.6 mg (0.3 mg each of
two DNA plasmids), 2.0 mg, and 6.0 mg. The immunization regimen consists
of each subject receiving the respective dose at day 0, month 1 and
month 3. The vaccine is delivered using Inovio’s proprietary CELLECTRA®
intramuscular electroporation delivery device.
All six patients in the second, intermediate dose cohort have been
enrolled; samples from the first four patients have been evaluated for
immune responses. As with the first cohort, the vaccination procedures
were well-tolerated by the subjects in the second cohort. In general,
reported adverse events and injection site reactions were mild to
moderate and required no treatment.