Inovio: there is beef there.

Inovio has finally disclosed the results from their P2 study of vaccine against the HPV-mediated cervical lesions. The results are good, but not great. Helpful though.

Human Papillary Virus (HPV) causes lesions on the genitalia and elsewhere. The virus is transmitted through sexual contact and enters the body through any breaks in the skin. The female reproductive system (the cervix primarily) are its primary targets. Left untreated, about a quarter of the infected individuals fight off the infection, the rest can get cervical cancer. There are two companies producing vaccines to prevent infection, but when infection occurs, there is no treatment.

Inovio has tested a DNA serum against the infection once it is in full bloom. Thirty percent of those receiving placebo (no vaccine) recovered vs a recovery of 49% of those receiving the vaccine. In the placebo group, 13% was virus-free, vs 40% in the treated group. There was a report of "robust" t-cell response in the treated group.

Researchers have learned a lot about cell biology from trying to find "the cancer gene." As the length of the names of genes involved in cancer grew, it became obvious that this was the wrong tack to follow. But, chromosomal breaks seemed to be involved. That is why INOVIO's vaccines hold out hope.

HPV is a DNA virus that carries the code for two proteins: E6 and E7. When the HPV DNA gets dragged into the cell, it is then incorporated into the cell's DNA and the proteins are expressed. E6 results in altered centriole formation ( the center that is involved in separating the new chromosomes from the old ones in the dividing cell). You even get chromosomal breakage. E7 complexes with another protein (E2) which normally ties up a tumor forming factor (p56). Once p56 is free, it promotes uncontrolled cell division.

Inovio's vaccine (3100) contains the DNA sequence for E6 and E7, probable promoters and maybe a sequence necessary for the antigen forming units to recognize the E6 and E7. How the vaccine works is a little fuzzy, but it works. Inovio is planning three P1 studies against cancers, a P3 study to fight off HPV infection and a number of studies against influenza, HIV and hepatitis C.