Copenhagen, Denmark – Symphogen announced today preliminary data from a phase 2 clinical trial with rozrolimupab (SYM001) in adult, RhD positive, non-splenectomized patients with Immune thrombocytopenia (ITP). The study showed rozrolimupab is well tolerated with no unexpected toxicities and shows preliminary signs of clinical and biological activity by decreasing haemoglobin values.
Preliminary results of the first-in-class anti-RhD antibody mixture rozrolimupab in ITP were presented today in a poster at the 16th Congress of the European Hematology Association meeting in London, UK (http://eha.eurocongres.com/16th/) by professor Tadeusz Robak of the University of Lodz, Poland.
Five dose groups comprising 36 patients were evaluated and described in the poster: 75, 100, 125, 150 and 200 ?g/kg. In the individual dose groups, up to 70% of patients responded. All reported adverse drug reactions, except for a severe event of headache in the 100µg/kg dose group, were of mild or moderate intensity. The reactions included pyrexia, decreased haemoglobin and events of headache. Laboratory data showed that haemoglobin values decreased in all patients, indicating biological activity. Haemoglobin values reverted towards baseline during the course of the trial.
The trial is designed to investigate the safety, tolerability and efficacy of a single dose of rozrolimupab in RhD positive, non-splenectomized patients with ITP. Patients were enrolled in this dose escalation (75 µg/kg – 350 µg/kg), multicentre, open label trial. Inclusion criteria included confirmed presence of thrombocytopenia with two individual pre-dosing platelet counts of < 30 x 109. The patients received a single iv dose of rozrolimupab and were evaluated for safety and efficacy. Response was defined as platelet count ? 30 x109/L and increase in platelet count from baseline by > 20 x 109/L at 7 days after dosing.
About Rozrolimupab (SYM001)
Rozrolimupab is a fully human anti-RhD monoclonal antibody (mAb) mixture, comprising 25 mAbs that bind to RhD. Rozrolimupab is produced by a single-batch manufacturing strategy, designed to capture the natural diversity of the human antibody response to RhD as a modern counterpart to the plasma-derived anti-RhD immunoglobulins currently used in the treatment of ITP. The beneficial effect of this agent in patients with ITP is also being evaluated at doses beyond 200µg/kg.
Symphogen develops antibody therapeutics (mixtures of monoclonal antibodies) to help people with serious diseases and significant unmet medical needs. With its proprietary, unique Symplex™ discovery, SymSelect™ lead selection and Sympress™ manufacturing platforms, the company captures the diversity and specificity of the natural immune response in rationally designed recombinant antibody compositions. Symphogen is maturing a diversified pipeline of internal and partnered products across multiple indications including cancer, autoimmune and infectious disease. Symphogen is a private biopharmaceutical company headquartered in Copenhagen, Denmark. For more information, please visit www.symphogen.com.
For additional information, please contact:
Jørgen Petersen, MD, DMSc
Chief Development Officer
Phone: +45 4526 5071
Ivan D. Horak, MD, FACP
Chief Scientific and Medical Officer
Phone: +1 908 938 9313