Date: 2017-08-30
Type of
information: Completion of patient enrollment
phase: 1
Announcement: presentation of results at the European Society for Medical Oncology (ESMO) 2016 Congress
Company: Molecular Partners (Switzerland)
Product: MP0250
Action
mechanism:
- protein/DARPIN. MP0250 is a multi-DARPin® product consisting of four domains targeting vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also binds to human serum albumin (HSA) to increase the plasma half-life and potentially tissue penetration.
Disease: solid tumors
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On August 30, 2017. Molecular Partners announced that
- recruitment has now been completed with 45 patients
- • On October 9, 2016. Molecular Partners announced additional details about its ongoing clinical oncology program MP0250. M.R. Middleton, Professor of Experimental Cancer Medicine, Department of Oncology at the University
of Oxford, UK has presented the completed phase 1 dose escalation interim results of MP0250 at the poster session 'Developmental Therapeutics' at the Conference of the European Society of Medical Oncology (ESMO). Prof. M.R. Middleton commented: “MP0250 used as single agent is the first DARPin® drug candidate to be studied in humans as systemic treatment. The drug is generally well tolerated and the side effect profile is consistent with profound inhibition of the VEGF pathway. We have seen encouraging signs of clinical activity in these heavily pretreated patients, with two patients showing significant reduction of tumor burden and 6 patients having prolonged stable disease. MP0250 has
the potential to become a new therapeutic in treating various tumor types.”
These data, now based on the total enrollment of 24 patients, are an important milestone in the development of DARPin® proteins as anticancer agents and expand the results that were published at the AACR -NCI-EORTC conference in November 2015:
• MP0250 was well tolerated at the higher dose levels (up to 8 mg/kg administered every 2 weeks). This was assigned as the maximally tolerated dose (MTD). Toxicities came primarily from the inhibition of VEGF, including dose-limiting toxicities of acute left ventricular failure, nephrotic syndrome and hypertension, gastrointestinal hemorrhage and thrombotic microangiopathy.
• MP0250 had a half-life of about 12 days and shows full exposure in all patients over the whole treatment period at all doses.
- • On October 27, 2015. Molecular Partners announced that interim clinical data on MP0250 will be presented from the ongoing Phase I dose escalation study in solid tumors. Prof. Dr. Jordi Rodon, Hospital Vall d’Hebron Institute of Oncology, Barcelona and a principal investigator of this study, will present the most recent data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston on November 07, 2015. In the corresponding abstract preliminary data from the Phase I study shows MP0250 to be well tolerated, to have a mean half-life around 11 days and to have sustained exposure on repeated dosing. In addition, there was disease stabilization exceeding 8 months in two patients suggestive of anti-tumor activity.
Is
general: Yes
