BioInvent and ThromboGenics Announce the Start of New Study of Novel Antibody Anti-Cancer Agent TB-403 (Anti-PlGF) by Partner Roche

Two new studies now ongoing: phase Ib/II in patients with aggressive brain tumour and phase Ib in primary liver cancer

17-May-2011 - Sweden

BioInvent International AB  and co-development partner ThromboGenics NV announced that their partner Roche has dosed the first patient in a phase Ib/II study with the novel antibody anti-cancer agent TB-403 (RG7334). The trial is in patients with glioblastoma multiforme, the most common and aggressive type of primary brain tumour in humans.

The multi-center, phase Ib/II trial will examine the safety and clinical effect of TB-403 in combination with Avastin® (bevacizumab) in patients with recurrent glioblastoma. Secondary objectives include safety, tolerability and pharmacokinetics of the combination. The trial will also include an evaluation of candidate biomarkers. The study will recruit approximately 100 patients.

The start of the phase Ib/II glioblastoma study has triggered a €4 million milestone payment to ThromboGenics and BioInvent. This is the second clinical milestone that they have received from Roche. The first milestone of €10 million was paid last year when Roche initiated an imaging study in patients with colorectal and ovarian cancer.

In March 2011, Roche initiated a phase Ib study of TB-403 in patients with primary liver cancer (hepatocellular carcinoma). This study will determine the safety, tolerability and dosage of TB-403 in combination with Nexavar® (sorafenib), as well as pharmacokinetics and pharmacodynamics.  The study will recruit 60-70 patients.

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