Biotech Business - March 1, 2021
Oncopeptides receives FDA approval
FDA has approved Oncopeptides’ PEPAXTO for patients with relapsed or refractory multiple myeloma. The U.S. Food and Drug Administration, FDA, has approved PEPAXTO (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy […]
Clinical Trials - January 8, 2021
Oncopeptides enrolls the first patient in phase 3 study
Oncopeptides has announced that the first patient has been dosed in the phase 3 LIGHTHOUSE study, evaluating the efficacy and safety of a triple combination therapy with melflufen plus dexamethasone and subcutaneous daratumumab compared to daratumumab alone. The phase 3 LIGHTHOUSE study is a randomized, open-label study in patients with relapsed refractory multiple myeloma who […]
Pharma Business - October 21, 2020
Oncopeptides has submitted an IND application to FDA
Oncopeptides has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), for OPD5 – a second drug candidate based on the Peptide Drug Conjugate platform (PDC). Oncopeptides plans to initiate clinical development of OPD5 with an open-label phase 1, dose escalation study on safety and tolerability of OPD5 as […]
Financing - October 19, 2020
Oncopeptides signs 40 million EUR loan agreement
Oncopeptides has entered into a loan agreement with the European Investment Bank (EIB), granting the company access to an unsecured loan facility of up to 40 million EUR. The loan may be used to further support the clinical development of melflufen, and the company’s transition from a R&D company into a fully integrated global biopharmaceutical […]
Clinical Trials - October 1, 2020
Oncopeptides initiates US Expanded Access Program
Oncopeptides announces that the open-label Expanded Access Program, sEAPort, for eligible U.S. patients, is formally open. Melflufen (INN melphalan flufenamide), is currently being evaluated in several clinical studies as a treatment for patients with triple-class refractory multiple myeloma. The sEAPort program is available to adults, age 18 and older, who have received at least two […]
Clinical Trials - September 8, 2020
Oncopeptides completes extended enrollment of Phase 3 study
Oncopeptides has announced that the last patient has been successfully enrolled in the phase 3 study OCEAN in relapsed refractory multiple myeloma (RRMM). The original enrollment target of 450 patients was reached in May 2020, but an analysis indicated that patients were staying longer on treatment than initially estimated. Thus, a decision was made to […]
