Molecular Partners reports promising initial safety and efficacy data from its ongoing phase 2 study of MP0250 in multiple myeloma
Molecular Partners AG announced initial safety and efficacy data from its ongoing phase 2 study of MP0250 in multiple myeloma (MM).
Eight patients have been treated in the first cohort of 8 mg/kg MP0250 and were included in the safety analysis set. No dose-limiting toxicities (DLTs) have been reported to date. Most frequent adverse events were Grade 1 and 2, except two Grade 3 adverse events (thrombocytopenia and transitory liver enzyme elevation) observed in two patients.
Of seven response evaluable patients receiving MP0250 in combination with bortezomib and dexamethasone, three patients showed partial response (PR) and one patient minimal response (MR). Responses were analyzed according to the International Myeloma Working Group (IMWG) criteria.
MP0250 is a proprietary DARPin® drug candidate neutralizing VEGF and HGF and thus blocking key escape pathways and resistance. Increases in VEGF and HGF are associated with disease progression in multiple myeloma and have been linked to poor prognosis: they are known to be able to stimulate neovascularization, bone destruction, and myeloma proliferation, migration, and adhesion in the bone marrow. MP0250 shows activity in many preclinical tumor models including in multiple myeloma models in which it enhances the effects of bortezomib on inhibition of M protein production and bone lysis and reduces invasion of tumor cells. MP0250 has shown a favorable safety profile in a phase 1 clinical study in 45 patients in advanced solid tumors.
In the phase 2 MM study, the safety and efficacy of MP0250 is examined in combination with bortezomib (Velcade®) and dexamethasone in patients with relapsed and refractory multiple myeloma (RRMM) who have failed standard therapies. The study is performed in Germany, Poland and Italy. A total of 40 patients are planned to be treated, 12 patients in the dose-escalation phase (Part 1) to establish a safe dose, and an additional 28 patients in the dose-expansion phase (Part 2) resulting in a total of 34 patients at the target dose. Additional safety and efficacy data are expected by the end of 2018.