Avantogen receives milestone payment from Endocyte

Endocyte will pay its first milestone payment to the Avantogen for Avantogen's successful submission of a Drug Master File (DMF) to the FDA for its proprietary vaccine adjuvant GPI-0100.

Endocyte is currently conducting a multi-centre, open-label, baseline-controlled, dose-ranging Phase I clinical study of an investigational targeted immunotherapy using GPI-0100. The study is designed to evaluate the safety and pharmacokinetics of the immunotherapy regimen. Endocyte's novel targeted immunotherapy is comprised of GPI-0100 adjuvant and a folate-conjugated molecule (EC17) that targets folate receptor positive tumor cells to potentially enhance tumour cell removal by cytokine stimulated immune cells. The over-expression of the folate receptor occurs in a number of malignancies, including kidney and ovarian cancers.

'This is the first milestone payment that we've received for GPI-0100, and it validates our commercialisation strategy for this exceptional adjuvant,' said Dr Leonard Firestone, CEO of Avantogen. 'We expect additional milestone payments from other licensees, including Pfizer Animal Health Division, in the near future. We anticipate that other companies will soon adopt GPI-0100 as their preferred vaccine adjuvant.'

More GPI Adjuvant Progress

This key milestone follows the granting of European patent number 099645 entitled 'Triterpene Saponin Analogues having Adjuvant and Immunostimulatory Activity'. The patent provides protection around the Company's immune-enhancing adjuvant GPI-0100 and its use as a component in vaccines and the initiation of preclinical trials for the use of GPI-0100 in a potential vaccine to the Herpes Simplex Virus (HSV-2) in European Union countries.

Additionally, Avantogen recently announced that, together with the University of Alabama at Birmingham (UAB), the company has commenced preclinical studies using GPI-0100 as an adjuvant to increase the immune response to a new vaccine designed to reduce the recurrence and shorten the duration of herpetic lesions caused by the Herpes Simplex Virus (HSV-2). The research will be conducted at UAB under the direction of Dr Earl Kern, research professor at UAB's department of pediatrics and a recognised expert in the area of Herpes viruses.

Adjuvants boost the physiologic response to a foreign substance by stimulating the immune system. GPI-0100, which Avantogen acquired from Galenica in 2004, is a modified, semi-synthetic saponin, a naturally occurring plant detergent or surfactant. The saponin upon which GPI-0100 is based occurs in the bark of a South American tree. GPI-0100 has been shown to stimulate both the antibody and cellular components of the immune system, and modifications made to the molecule increase its stability and safety profile versus naturally occurring saponins.