ThromboGenics and BioInvent regained full global rights to the early clinical-stage anti-angiogenic antibody candidate TB-403 from Roche, following the latter’s prioritization of its pipeline. The partners say they plan to evaluate the antibody in specific cancer and noncancer indications, including ophthalmologic disorders. Roche had negotiated exclusive global development rights to TB-403 from ThromboGenics and BioInvent in June 2008.
TB-403 is a humanized monoclonal antibody that blocks the activity of placental growth factor (PlGF), which is overexpressed in some cancers and chronic inflammatory conditions. Roche has already undertaken early clinical testing in patients with solid tumors, including colorectal, ovarian, and liver cancers. A study in patients with glioblastoma multiforme is ongoing.
BioInvent and ThromboGenics teamed up in 2004 on a long-term collaborative research and licensing agreement to codevelop antibody-based drugs for the treatment of vascular indications and cancer. The two products currently included in the collaboration are TB-403 and TB-402, a fully-human anti-Factor VIII monoclonal antibody in development as anticoagulant therapy. However, in parallel with the announcement that they have regained full rights to TB-403, BioInvent and ThromboGenics separately reported the decision to drop further development of TB-402, due to Phase IIb study data suggesting the drug may cause a higher rate of bleeding events than rivaroxaban (Bayer’s Xarelto®).
The trial compared the benefits of either TB-402 or rivaroxaban in the prevention of venous thromboembolism (VTE) in 632 patients undergoing hip replacement surgery. TB-402 was administered as a single intravenous infusion 2–4 hours postoperatively, while rivaroxaban was given orally once daily for 35 days. While the incidence of VTE was similar among patients treated with either TB-402 or rivaroxaban, major or clinically relevant nonmajor bleeding occurred in 6.5% of the patients treated with TB-402, compared with just 1.4% of patients treated with rivaroxaban. “The result, while disappointing, means that we do not need to invest any further in the development of TB-402,” comments Patrik De Haes, Ph.D., ThromboGenics’ CEO.