On October 09, 2016 Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company that is developing a powerful new class of therapies known as DARPin therapies, reported 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 presents today 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) (Free ESMO Whitepaper) (Press release, Molecular Partners, OCT 9, 2016, View Source [SID:SID1234515660]).
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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.
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 (Free AACR Whitepaper)-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.
2/3 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 encouraging 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.
About the DARPin technology
Molecular Partners is progressing programs in ophthalmology in partnership with Allergan and in oncology with a proprietary pipeline of DARPin drug candidates. The most advanced assets globally is abicipar, a molecule currently in phase 3 which is being advanced by Allergan. Abicipar is being followed by several DARPins for various ophthalmic indications. The most advanced systemic DARPin molecule, MP0250, is in clinical development for solid tumors and is moving to phase 2 for hematological and solid tumors. The second most advanced oncology DARPin drug candidate is MP0274, which has broad anti-HER activity, inhibiting HER1, HER2, and HER3- mediated downstream signaling via Her2 and leading to induction of apoptosis. MP0274 is currently in preclinical development. There is a growing pipeline of immune-oncological treatments following the two proprietary lead assets.