Clinical Development
The clinical development of targeted therapies for difficult-to-treat hematological diseases and malignancies are based on our peptide-drug conjugate platform, PDC. Our focus We are focusing on the late-stage...
Our clinical studies
Regulatory strategy
Regulatory submission in the US The FDA submission of a New Drug Application for accelerated approval of melflufen in combination with dexamethasone in triple-class refractory multiple myeloma, is major...
O-12-M1
Rationale and study design O-12-M1 was an international, multicenter, open-label phase 1/2 study to establish the dose of melflufen in combination with dexamethasone and investigate the treatment response...
HORIZON
The phase 2 HORIZON study is a pivotal, single-arm, multicenter, phase 2 study evaluating the safety and efficacy of melflufen in combination with dexamethasone in patients with relapsed refractory multiple...
OCEAN
The phase 3 OCEAN study is a global, randomized, head-to-head, open-label study, evaluating the efficacy and safety of melflufen and dexamethasone, versus pomalidomide and dexamethasone in patients with...
ANCHOR
ANCHOR is a phase 1/2 open label multicenter study evaluating the safety and efficacy of melflufen plus dexamethasone in combination with either daratumumab or bortezomib in patients with relapsed refractory...
BRIDGE
The phase 2 BRIDGE study is an open-label, single-arm study, designed to evaluate the pharmacokinetics, safety and efficacy of melflufen in combination with dexamethasone in multiple myeloma patients...
ASCENT
The phase 1/2 ASCENT study is the first study with melflufen outside multiple myeloma. The study is an open-label study with melflufen and dexamethasone for patients with AL-amyloidosis. The patients...
PORT
The phase 2 PORT study is an open-label, randomized, cross-over study which compares safety, tolerability and efficacy, of peripheral or central intravenous administration of melflufen in combination...
LIGHTHOUSE
The phase 3 LIGHTHOUSE study is a randomized, open-label, phase 3 study of melflufen and dexamethasone in combination with daratumumab compared to daratumumab alone in patients with relapsed and refractory...