BioInvent and ThromboGenics to Receive €10 Million Milestone as Partner Roche Begins New Clinical Study with TB-403
Trial to study patients with colorectal and ovarian cancer
BioInvent International AB and ThromboGenics NV announcd that their partner Roche will begin an imaging study with the novel anti-cancer antibody TB-403 (RG7334) in patients with metastatic, treatment-refractory, colorectal and ovarian cancer. BioInvent and co-development partner ThromboGenics will receive a milestone payment of €10 million 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.
This trial is a multi-centre, open-label (monotherapy), dose-finding study with intravenous TB-403. The primary objective of the study will be 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 will recruit up to 50 patients across three European sites.
With the start of this study, Roche will assume responsibility for all future development of TB-403, continuing the work started by BioInvent and ThromboGenics. A Joint Steering Committee made up of representatives from Roche, BioInvent and ThromboGenics will continue to oversee research and development activities. In addition, Roche will continue to provide funding to BioInvent and ThromboGenics for research activities related to TB-403.
A Phase I trial found that TB-403 was well tolerated with no reported dose limiting toxicity. The results from this Phase I study were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, U.S. in November 2009.
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