GPC Biotech starts trials of cancer antibody
anticancer monoclonal antibody, 1D09C3, which has already proved
effective in the treatment of lymphoid tumours including
non-Hodgkin's lymphoma.
The study aims to evaluate 1D09C3 in patients with relapsed or refractory B-cell lymphomas who have failed prior standard therapy. In determining antibody safety and tolerance in patients, a recommended dose and schedule can be compiled for subsequent Phase II studies.
Marcel Rozencweig, senior vice president, drug development of GPC Biotech, said: "While good progress has been made in treating non-Hodgkin's lymphoma, the most common form of lymphoma, in recent years, the vast majority of patients eventually relapse. Thus, there remains a major unmet medical need for novel therapies to treat patients who have relapsed or become resistant to other treatments."
"1D09C3, is distinct from the mechanisms of action of the products currently used for the treatment of lymphoid tumours."
1D09C3 is an anti-MHC (major histocompatibility complex) class II monoclonal antibody isolated in collaboration with MorphoSys from its HuCAL library of human antibodies. It binds to certain cell surface receptors, selectively killing activated, proliferating MHC class II-positive tumour cells, which include those in B-cell and T-cell lymphomas.
Since most lymphoma patients are immunocompromised as a result of prior chemotherapy or the disease itself, this is potentially a significant advantage over most antibodies targeting B-cell lymphomas. 1D09C3, which was isolated in collaboration with MorphoSys from its HuCAL library of human antibodies, has a very high binding affinity to its MHC class II target.
In 2004, it was estimated that more than 54,000 people in the US and about 64,000 people in the European Union were diagnosed with non-Hodgkin's lymphoma, the most common form of lymphoma. 1D09C3 has been shown to induce programmed cell death and does not require a functioning immune system for its cell-killing effect.
Pre-clinical data demonstrated the efficacy of 1D09C3 in a variety of tumour models, including a combination with blockbuster drug Rituxan (rituximab) in a non-Hodgkin's lymphoma (NHL) model, showed greater efficacy than in either treatment alone.
Rituxan which is approved in over 70 countries worldwide and is used to treat various types of NHL, achieved sales of $1.5 billion (€1.2 billion) in 2003. Despite Rituxan's great success, a large number of patients do not respond to treatment, and most eventually become resistant, generating a need for additional therapeutic options.
Estimated at $1.47 billion in 2004, Frost & Sullivan expects the total European monoclonal antibody therapeutics market to grow at a compound annual growth rate (CAGR) of 34.1 per cent to amass $11.4 billion in 2011.
There are currently ten products commercially available in Europe including Remicade, Zevalin, Campath, Herceptin, Rituxan, Simulect, Zenapax Synagis, ReoPro and the fully human mAb Humira. While chimeric mAbs currently control the market, humanised and human mAbs are expected to dominate in future.
