Papilloma Vaccine to Be Developed - Brief Article

Applied Genetics News, April, 2000

Schering AG (13342 Berlin, Germany; Tel: 30-468-1111, Fax: 30-468-15305, Website: www.schering.de) and MediGene AG (Lochhamer Str. 11, Munchen (Munich) 821; Tel: 089-895-00033) have formed an alliance to develop and commercialize MediGene's Viral Vaccine for the treatment of precancerous lesions of the cervix caused by human papilloma viruses (HPV).

Schering has been granted a world-wide exclusive license with the right to grant sublicenses. MediGene has an option for distribution of the vaccine in countries in which Schering decides not to commercialize. The total deal value excluding undisclosed royalties on sales could amount to euro$55 million. MediGene will be responsible for all research and pre-clinical studies. MediGene and Schering will jointly conduct the phase I/II study for proof of concept. Schering will undertake promotion for further clinical studies as well as registration.

Cervical cancer and pre-cancerous lesions of the cervix are associated with the "high risk" human papilloma virus, mainly types 16 (50 to 70%) and types 18, 31 and 45 (total >90%). Despite extensive screening, there are more than 450,000 cases of cervical cancer and 350,000 annual deaths reported world-wide every year. About 1 to 4% of the female population have high grade cervical dysplasia.

"The present treatments available for precancerous lesions very often become invasive and may cause infertility or heavy disorders in following pregnancies," says Guenter Stock, member of the board of executive directors of Schering AG. "MediGene's therapeutic vaccine could offer a thorough treatment without any side effects to women with pre-cancerous lesions who are at risk for progression to cervical cancer."

"Schering is the optimal partner for MediGene's vaccine due to the company's expertise in both gynecology and oncology," comments Peter Heinrich, MediGene's CEO.

MediGene's CVLP-technology is based on chimeric virus-like particles (CVLPs) built up by a HPV-L1E7 fusion-protein, which self-assembles into virus-like particles able to cause a pseudo-infection. The CVLPs stimulate the immune system both to prevent infections (prophylactic immunization) and to destroy HPV infected cells (therapeutic immunization). The particles consist of a HPV 16 - L1E7 fusion-protein that have a double function: L1 structural protein induces neutralizing antibodies whereas the shortened E7 regulatory protein induces a cytotoxic T cell response.