Date: 2017-05-30
Type of
information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: Molecular Partners (Switzerland)
Product: MP0250
Action
mechanism:
- protein/DARPIN. MP0250 is a multi-DARPin blocking both vascular endothelial growth factor (VEGF) and hepatocyte
growth factor (HGF) from binding to their receptors, thereby inhibiting tumor growth and tumor proliferation.
Disease: multiple myeloma
Therapeutic
area: Cancer - Oncology
Country: Germany, Italy, Poland
Trial
details:
Latest
news:
- • On May 30, 2017. Molecular Partners announced that the first patient was dosed in the phase 2 multiple myeloma study of its lead oncology asset MP0250. In the first phase 2 study, the efficacy and safety of MP0250 will be examined in combination with bortezomib (Velcade®) and dexamethasone in patients with multiple myeloma who have failed standard therapies. The study will be performed in three different countries: Germany, Poland and Italy. Initial safety data are expected in 2017 and efficacy data in 2018.
• On October 9, 2016. Molecular Partners provided an update on phase 2 strategy for MP0250. The first phase 2 study will examine MP0250 in combination with bortezomib and dexamethasone in patients with multiple myeloma who have failed proteasome and IMiD based standard therapies. The first regulatory submission for such study is planned in Q4 2016. Based on the data from phase 1 in solid tumors, Molecular Partners decided to initiate an additional phase 2 study for a solid tumor indication. Study details will be disclosed in H1 2017.
- • On January 8, 2016, Molecular Partners announced its Phase 2 strategy for MP0250, a multi-DARPin drug candidate that blocks vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), in multiple myeloma. The company plans to conduct a Phase 2 clinical trial of MP0250 in combination with bortezomib (Velcade®) and dexamethasone in patients with multiple myeloma who have developed resistance to bortezomib and have received at least two prior regimens, including bortezomib and an immunomodulatory drug (IMiD). Molecular Partners expects to enroll the first patient in the second half of 2016.
In a preclinical model of MM, the combination of MP0250 and bortezomib showed substantial antitumor activity in settings where bortezomib had very little effect as a single agent. In addition to inhibiting tumor growth, the combination of MP0250 and bortezomib resulted in a significant reduction in bone destruction, one of the most important clinical hallmarks of this disease.
The announcement of Molecular Partners’ Phase 2 strategy for MP0250 in MM comes as the company continues to advance the drug candidate’s Phase I program in patients with solid tumors. A team of independent researchers recently presented preliminary phase 1 data demonstrating good tolerability, favorable pharmacokinetics , and sustained exposure over multiple applications of MP0250 in patients with solid tumors. The Phase I results, presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, Mass., USA, constitute the first demonstration in patients of the potential role of DARPin-based therapy in oncology.
Is
general: Yes
