BioInvent International AB and ThromboGenics NV announce 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 per cent and BioInvent 40 per cent 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.
Svein Mathisen, CEO of BioInvent, commented, "This important milestone underpins our belief that TB-403 could become an important product for the treatment of cancer. The Roche alliance has so far generated € 65 million in revenues to date to BioInvent and ThromboGenics. In the short term, we expect additional payments to be made as Roche progresses this product through early stage development. In total, there is the potential for a further € 435 million in milestone payments plus product royalties."
Dr Patrik De Haes, CEO of ThromboGenics, also commented, "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 successfully 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."
The novel mechanism of action of TB-403 represents a potentially promising cancer therapy.
BioInvent International AB is a research-based pharmaceutical company that focuses on developing antibody drugs.