Clinical Trials

Date: 2011-05-16

Type of information: Treatment of the first patient

phase: 1b-2

Announcement: treatment of the first patient

Company: Roche (Switzerland)

Product: TB-403 (RG7334)

Action mechanism:

monoclonal antibody. TB-403 is a humanized monoclonal antibody directed towards placental growth factor (PIGF), expected to act by blocking the formation of the new blood vessels that are required for tumour growth. Preclinical exploration of PIGF biology suggests a role in tumour angiogenesis and metastasis and a limited role in the maintenance of normal vasculature. This mode of action could result in therapeutic benefit with an acceptable side effect profile. Two phase I clinical trials have found that TB-403 was well tolerated with no reported dose limiting toxicity. TB-403 was in-licensed by ThromboGenics from the Flanders Institute for Biotechnology (VIB), where the therapeutic potential of anti-PlGF agents to treat cancer was first developed by Prof. Peter Carmeliet at the University of Leuven, Belgium.

Disease: glioblastoma multiforme

Therapeutic area: Cancer - Oncology

Country:

Trial details:

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.

Latest news:

• On May 16, 2011, BioInvent International and its co-development partner ThromboGenics have 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 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.