BioInvent and ThromboGenics report that partner Roche will begin an imaging study with the cancer antibody TB-403 in patients with metastatic, treatment-refractory colorectal and ovarian cancer. BioInvent and co-development partner ThromboGenics will receive a milestone payment of €10 million (approximately $12.35 million), according to the firms’ deal signed in June 2008. ThromboGenics, which discovered TB-403, receives 60% and BioInvent 40% of all revenue from the collaboration with Roche.
This trial is a multicenter, open-label, 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 MRI) and to identify the minimal 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. A joint steering committee made up of representatives from all three companies will continue to oversee R&D activities. In addition, Roche will provide funding to BioInvent and ThromboGenics for research activities related to nononcology applications of TB-403.
A Phase I trial found that TB-403 was well tolerated with no reported dose-limiting toxicity. This humanized mAb is directed toward placental growth factor (PIGF) and is expected to act by blocking the formation of the new blood vessels that are required for tumor growth. Preclinical exploration of PIGF biology suggests a role in tumor angiogenesis and metastasis and a limited role in the maintenance of normal vasculature.
“The Roche alliance has so far generated €65 million (roughly $80.19 million) in revenues to date to BioInvent and ThromboGenics,” notes Svein Mathisen, CEO of BioInvent. “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 (approximately $536.61 million) in milestone payments plus product royalties.”
The partnership started in June 2008 with Roche paying €50 million (about $61.68 million) up front. In January 2009, ThromboGenics and BioInvent earned a €5 million (roughly $6.17 million) technology transfer fee. Additionally, Roche will pay double-digit royalties on future sales.