MorphoSys AG announced that the first patient in a phase 1/2a clinical trial of its cancer antibody MOR202 has been dosed. MOR202 is a fully human HuCAL antibody directed against CD38, a therapeutic target which is highly expressed on multiple myeloma tumour cells and certain leukaemias. The phase 1/2a, open-label, multi-centre, dose-escalation study will evaluate the safety and preliminary efficacy of MOR202 in patients with relapsed or refractory multiple myeloma.
"We will evaluate MOR202 both as a monotherapy and in combination with standard therapy. I am very pleased that this program has been brought forward so successfully by our development team over the past months and now represents another valuable clinical asset in our portfolio. In total, this is our third proprietary antibody programme in clinical trials, following MOR103 in rheumatoid arthritis and MOR208 in chronic lymphocytic leukaemia," commented Dr Arndt Schottelius, chief development officer of MorphoSys AG.
Patients with relapsed or refractory multiple myeloma will be treated with different doses of the HuCAL-derived antibody MOR202. It is also planned to evaluate the safety of MOR202 in combination with approved therapy. Pre-clinical studies recently presented at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO) demonstrated enhanced cytotoxic activity of MOR202 in combination with Velcade and Revlimid, supporting the clinical trial design.
In total, the clinical trial is anticipated to enrol a maximum of 82 patients and will be conducted in several centres in Germany and Austria. The primary endpoints of the trial are to determine the safety and tolerability of multiple doses of MOR202 in patients. Secondary outcome measures will evaluate pharmacokinetics and preliminary efficacy.
MorphoSys is an independent biotechnology company that develops novel antibodies for therapeutic, diagnostic and research applications. The company's HuCAL technology is one of the most powerful methods available for generating fully human antibodies.