Roche will terminate a license agreement with Transgene, originally signed in 2007, that was centered on development of the Phase IIb-stage therapeutic vaccine candidate TG4001 (Roche-designated RG3484), for the treatment of high-grade cervical intraepithelial neoplasis (CIN) caused by HPV. Transgene says Roche has indicated that its decision to pull out of the program is strategy-driven, rather than data-driven. The French firm will regain full development and commercialization rights to TG4001 once the agreement has been formally terminated later this year.
Transgene doesn’t expect Roche’s move will impact on the ongoing Phase IIb trial, interim data from which is expected by the end of 2011 or early 2012. It says if the data is positive, it hopes the candidate will be progressed into Phase III development by late 2012 or early 2013, if it can find a new co-development partner to share late-stage costs. It aims to ensure that any new partnership deal will give it greater ownership rights to the vaccine than its original agreement with Roche.
TG4001 is an MVA virus-based candidate that expresses the mutation-inactivated human papilloma virus 16 (HPV16) E6 and E7 oncoproteins and human interleukin-2. Under terms of the original 2007 deal with Roche, the Swiss drugs giant acquired an exclusive license to TG4001 and potentially other therapeutic vaccine candidates resulting from the firms’ joint work on HPV-related diseases. Roche retained the responsibility for funding all future development costs of TG4001, and was to conduct the Phase IIb and Phase III trials. Transgene received €23 million in up-front and milestone payments, and could have been due up to another €195 million in development and sales milestones dependent on the achievement of specified targets in various HPV-related areas.