Molecular Partners‘ multiple myeloma treatment candidate MP0250 showed positive preliminary safety and effectiveness results in an ongoing Phase 2 clinical study, according to the biopharmaceutical company.
The first dose (8 mg per kg body weight) of the therapy has been tested in eight myeloma patients. A safety analysis showed no relevant toxicity problems and two cases of severe adverse events – thrombocytopenia (low levels of platelets in the blood) and an increase in transitory liver enzyme.
MP0250 is being assessed in combination with the injectable myeloma medication Velcade (bortezomib) and dexamethasone (a corticosteroid). Patients enrolled in the trial (NCT03136653) have relapsed and refractory multiple myeloma (RRMM) who have failed to respond to standard treatments.
The combination therapy resulted in a partial response in three patients and a minimal response in one. The analysis was conducted according to the International Myeloma Working Group (IMWG) criteria.
Molecular Partners plans to study 40 patients, 12 of them in the dose-escalation part to establish a safe dose, and the remaining 28 patients in the dose-expansion part to obtain additional information, such as anti-tumor activity.
Investigators expect additional safety and efficacy results by the end of 2018. The trial is being conducted in Germany, Poland, and Italy, and is currently recruiting adult myeloma patients who have received at least two previous lines of therapy but have failed to respond. For more information, visit the clinical trial website here.
”We are very pleased with the good initial safety and tolerability data we observed in the first eight patients treated with MP0250 in combination with bortezomib and dexamethasone,” Andreas Harstrick, chief medical officer at Molecular Partners, said in a press release.
“We look forward to evaluating additional patients at higher doses of MP0250 with bortezomib and dexamethasone to treat resistant multiple myeloma patients,” Harstrick added.
MP0250 neutralizes vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF). Increases in VEGF and HGF are linked to disease progression and poor prognosis in multiple myeloma. The disease causes bone destruction, formation of new blood vessels, and tumor growth in the bone marrow.
MP0250 improved the effects of Velcade in previous preclinical studies with tumor models, including myeloma. The results included a reduction in both bone fractures and tumor cells.
MP0250 also showed positive safety data in a Phase 1 trial in 45 patients with advanced solid tumors. As a result, the company will test MP0250 in a Phase 1b/2 study in patients with a subset of lung cancer. This is part of Molecular Partners’ preclinical pipeline, which also includes MP0274, an additional cancer drug candidate currently in Phase 1 clinical development (NCT03084926).
MP0250 and MP0274 use the company’s DARPin technology. According to Molecular Partners, DARPin products are potent, specific, safe, and are able to bind to more than five targets at once, which is a significant benefit over currently available protein therapies.
DARPin is a cost-effective, high-production technology for the treatment of serious diseases, such as cancer and sight-threatening conditions, according to the company.