ThromboGenics and co-development partner BioInvent said that with the initiation of the trial they will receive a milestone payment of EUR10m from Roche under the terms of the strategic alliance agreement signed in June 2008.
ThromboGenics, which discovered TB-403, receives 60% and BioInvent 40% of all revenue from the alliance with Roche for this anti-cancer antibody.
The trial is a multi-centre, open-label (monotherapy), dose-finding study with intravenous TB-403. The primary objective of the study is to establish the TB-403 concentration-pharmacodynamic (PD) effect relationship using DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) and to identify the minimally PD effective dose. The trial is expected to recruit up to 50 patients across three European sites.
ThromboGenics and BioInvent said that with the start of this study, Roche is expected to assume responsibility for all future development of TB-403, continuing the work started by ThromboGenics and BioInvent.
A Joint Steering Committee made up of representatives from Roche, ThromboGenics and BioInvent will continue to oversee research and development activities. In addition, Roche is expected to continue to provide funding to ThromboGenics and BioInvent for research activities related to TB-403.
Patrik De Haes, CEO of ThromboGenics, said: “We are very pleased to report today’s important milestone as a result of Roche’s decision to move forward with the development of TB-403. The fact that Roche has initiated this study marks a positive turning point, indicating that ThromboGenics and BioInvent have completed their responsibilities for clinical development.
“We have always maintained that this selective anti-angiogenic therapy could play an important role in the treatment of cancer, and we very much look forward to reporting the results of this trial.”
Svein Mathisen, CEO of BioInvent, said: “The Roche alliance has so far generated EUR65m in revenues to date to ThromboGenics and BioInvent. In the short term, we expect additional payments to be made, as Roche progresses this product through early stage development.”