NUTLEY N.J.—In an agreement that Transgene CEO Phillippe Archinard labels a "transforming event" for his company's future, Transgene and Roche have agreed to an exclusive worldwide collaboration to further develop and commercialize TG 4001 – which has completed Phase II clinical studies – for treatment of high grade cervical intraepithelial neoplasia associated with human papilloma virus (HPV). Other therapeutic vaccine candidates currently in Transgene's pipeline that are part of the agreement include TG 4010 for non small cell lung cancer now in Phase IIb trials; TG 1042 for cutaneous B-cell lymphoma (Phase II); TG 4040 for chronic hepatitis C (Phase I); and MyoDys for Duchenne and Becker Muscular Dystrophy, which has completed Phase I studies.
Under the terms of the agreement, Roche will assume all future development costs for TG 4001 and lead the Phase III studies. Transgene will receive 13 million euros upfront and 10 million euros as a near-term regulatory milestone payment related to planning the Phase III studies. In total, Roche may pay Transgene up to 195 million euros as the program moves forward, in addition to double-digit escalating royalties on sales once a product is marketed.
Transgene, Archinard notes, was one of the first biotechs when it was founded in 1979. Until 1990 the company operated principally as a CRO, which facilitated its development of a broad panel of capabilities and technology, but no products of its own. Early in the 90's, the company was acquired by the Mérieux family, which continues to hold a 52 percent stake via bioMérieux, a billion euro per year diagnostics company. Since 1995, Transgene has focused on gene transfer and gene therapy via the vaccine approach.
"It is very important that when you hand over assets, you place them in good hands," Archinard says, "Roche is the best possible partner for us. The company is an aggressive leader in developing first-in-class products. The agreement validates our development capabilities and will enhance cash flow, short- and long-term, which in turn will allow us to be more ambitious in our development program."
"At Roche, partnering has a strong history," says Dr. Robin Breckenridge, VP, global head operations and information for pharma partnering at Roche. "Genentech is a notable example. It is still treated as an independent organization with complementary capabilities. We go through a rigorous and effective process before finalizing a collaboration. With Transgene, for example, discussions began in the middle of last year and took six months. Transgene had developed the asset though Phase II and we believed that they have demonstrated some clinical efficacy. Our technology gave us access to viral tests for HPV so we could determine viral loads."
Dr. Breckenridge notes that Roche's goal for every one of the chemical entities it develops is for it to have a biomarker associated with it and the company hopes that Transgene will provide such an opportunity with HPV16. Based on Phase II trials, he believes this result is possible.
Clinical trials are scheduled to begin here and in Europe with a group of about 500 patients within the next 12 months, Dr. Breckenridge says.