The agreement includes Transgene’s lead therapeutic vaccine candidate TG 4001, currently in clinical development to treat neoplasia, a precancerous cervical abnormality which can lead to cervical cancer. Under the agreement, Roche will lead worldwide development and commercialization. TG 4001 has completed phase II studies and is in planning for entry into phase III studies.
“Transgene’s expertise in viral vaccine therapeutics complements our core capabilities in oncology and virology drug development. In addition, as Roche is a leader in in vitro diagnostics with strong capabilities in HPV detection, our collaboration with Transgene has the potential to expand and evolve into an integrated personalized medicine approach,” said Peter Hug, Roche’s global head of pharma partnering.
Transgene will receive E13 million as an upfront payment and E10 million as a milestone payment. Roche may pay Transgene up to E195 million, upon the achievement of certain further development and sales-based events in various HPV-related indications. Transgene is also entitled to double-digit escalating royalties on sales.
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.