Drug Development Pharma - May 18, 2020
Oncopeptides announces new data
Oncopeptides has announced that data from the phase 2 study HORIZON, and additional clinical and preclinical data that further evaluate the therapeutic peptide-drug conjugate platform, have been accepted by the European Hematology Association (EHA). “The primary read-out of the HORIZON-data represents an important milestone for Oncopeptides. They lay the ground for the New Drug Application […]
Clinical Trials - March 20, 2020
Oncopeptides’ provides update on its clinical programs due to the COVID-19 pandemic
Oncopeptides has announced measures the company is taking in response to the global spread of the novel coronavirus (COVID-19) pandemic. Most importantly, the phase 2 HORIZON study will not be affected and FDA submission plans are on track for a filing late Q2. The phase 3 OCEAN study with 423 out of 450 planned patients […]
Clinical Trials - December 9, 2019
Promising data from Oncopeptides
Oncopeptides has presented updated data from its ongoing Phase 2 ANCHOR (OP-104) triple combination study. In the data presented at the ASH Annual Meeting 2019, melflufen and dexamethasone demonstrated positive efficacy in combination with daratumumab or bortezomib in patients with relapsed/refractory multiple myeloma (RRMM). Preclinical data supporting clinical development of melflufen in AL amyloidosis was […]
In a new job - August 25, 2019
Oncopeptides’ Chief Medical Officer steps down
Johan Harmenberg has reached retirement age and as the company continues to expand its activities he has decided to step down as CMO but continue to work as a member of the company’s medical team. Klaas Bakker has been appointed as the new Chief Medical Officer (CMO) for Oncopeptides, starting in November. From 2015 to […]
Clinical Trials - June 4, 2019
New data from Oncopeptides
Data from the company’s Phase 1/2 O-12-M1 clinical study of lead candidate melflufen demonstrate that melflufen may offer positive disease stabilization and favorable time to next treatment (TTNT) outcomes in heavily-pretreated patients with relapsed/refractory multiple myeloma (RRMM). Overall conclusions from the data presented include: Melflufen plus dexamethasone treatment results in disease stabilization in 76% of RRMM […]
Pharma Business - May 21, 2019
Oncopeptides to apply for accelerated approval in the US
After discussions with the FDA, the company has initiated the preparation for submitting a New Drug Application (NDA) for accelerated approval of melflufen for the treatment of patients with triple-class refractory multiple myeloma. A dialogue with the FDA During the spring, Oncopeptides has been engaged in dialogue with the FDA to explore whether melflufen could […]