AnGes/GenoLac's novel oral HPV vaccine shows early promise
This article was originally published in Scrip
The Japanese bioventure AnGes MG has unveiled preliminary clinical results with a novel oral vectored vaccine against human papillomavirus (HPV) that it sees as sufficiently promising to warrant the product's continued development.
AnGes is co-developing the therapeutic vaccine with a small Japanese start-up, GenoLac, which in turn has licensed oral mucosal vaccine delivery technology from the South Korean firm BioLeaders.
The Phase I dose escalation study is being conducted by a research group at the University of Tokyo and is investigating the once-daily administration of up to six capsules of the product for five days a week in a week 1, 2, 4 and 8 dosing schedule. Results so far show no safety issues at any dose, while the most promising signs of efficacy against CIN3 (cervical intraepithelial neoplasia stage 3) severe dysplastic lesions have been observed at the two highest doses.
The study will continue for another 12 to 18 months with a focus on the higher doses to enable a fuller evaluation of safety and efficacy, AnGes said.
The vaccine targets the HPV E7 protein, which together with E6 is one of the major oncogenes involved in malignant cervical cancer, being highly expressed in intraepithelial neoplasms. The precancerous cervical lesions caused by HPV are closely linked to the eventual development of cervical cancer, the aim of the E7 vaccine being to control these and so head off the transition to full-blown malignancy.
The technology licensed by Okinawa-based GenoLac enables the production of oral immunogenic proteins through a lactobacillus-based antigen protein display platform. The exogenous target antigen can then be expressed on the bacteria's surface using a PgsA gene and anchor protein derived from a strain of Bacillus subtilis.
The live lactobacilli, which are generally recognised as safe in food regulations, are ingested, providing the delivery vector for the antigen.
AnGes has said that it is aiming to develop the vaccine globally assuming continued positive clinical results. But it is not alone in the field of oral HPV vaccines as other firms including Indian Immunologicals have disclosed that they are working on similar products.