Roche and Transgene enter partnership on therapeutic vaccines

Swiss-based Roche and French biopharma company Transgene have entered into an exclusive worldwide collaboration agreement to develop and commercialise products from Transgene's therapeutic vaccine programme against Human Papilloma Virus-mediated diseases.

The agreement includes Transgene's lead therapeutic vaccine candidate TG 4001 (MVA-HPV-IL2), currently in clinical development to treat high grade cervical intraepithelial neoplasia (CIN2/3), a precancerous cervical abnormality which can lead to cervical cancer. Under the agreement, Roche will lead worldwide development and commercialisation.

TG 4001 has completed Phase II studies and is in planning for entry into Phase III studies. Roche will fund all future costs associated with the development of TG 4001 and will lead the Phase III studies.

Transgene will receive Euro 13m as an upfront payment and €10m as a near-term regulatory milestone payment related to planning the Phase III studies. Roche may pay Transgene up to €195m, upon the achievement of certain further development and sales-based events in various HPV-related indications.

Roche will hold all manufacturing rights but has agreed to allocate, on commercial terms, exclusive responsibility to Transgene for the clinical-trial supply of TG 4001 and additional HPV products, which may be developed in the future. This agreement will be extended to commercial-supply manufacturing for an initial period.

'Transgene is an ideal strategic fit for Roche, offering a differentiated approach to a precancerous condition with high unmet need,' said Peter Hug, Roche's global head of pharma partnering. 'Transgene's expertise in viral vaccine therapeutics complements our core capabilities in oncology and virology drug development.'