Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounces that the Com­pany has in­formed the Euro­pean Medicines Agency, EMA, about its intention to submit an appli­ca­tion for a con­di­tional mar­ket­ing autho­ri­za­tion of mel­flu­fen (INN mel­phalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in re­lapsed re­frac­tory mul­ti­ple myeloma (RRMM).

The de­ci­sion to submit an appli­ca­tion for con­di­tional ap­prov­al has been grounded on an in-depth analysis of the regu­la­tory en­viron­ment and is endorsed by key opinion leaders in the EU. Previously the Com­pany in­tended to await …

Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) an­nounced to­day 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 prior lines of ther­apy and whose mul­ti­ple myeloma is re­frac­tory to at least one pro­te­a­some in­hib­i­tor, one immuno­modu­la­tory drug and one anti-CD38 mono­clonal anti­body, (i.e., triple-class re­frac­tory …

Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounces that the last patient has been suc­cess­fully en­rolled in the pivotal 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 leave recruitment open to ensure that the num­ber of dis­ease pro­gres­sion events needed to com­plete the study would be reached within a reason­able time­frame. An addi­tional 45 …

Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounces that the US Food and Drug Admin­istra­tion, FDA, has granted priority re­view for Oncopeptides' New Drug Appli­ca­tion seek­ing ap­prov­al of mel­flu­fen (INN mel­phalan flufenamide), in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of adult patients with mul­ti­ple myeloma whose dis­ease is re­frac­tory to at least one pro­te­a­some in­hib­i­tor, one immuno­modu­la­tory agent and one anti-CD-38 mono­clonal anti­body, (i.e., triple-class re­frac­tory mul­ti­ple myeloma patients). The FDA has set a PDUFA-date (Prescription Drug User Fee Act), which is the target date for their re­view …

Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounced that the first patient has been en­rolled in the phase 2 PORT study. The study, which is ex­pected to be fully recruited in De­cem­ber 2020, is an open-label, ran­dom­ized, cross-over study which compares safety, tol­er­a­bil­ity and ef­fi­cacy of periph­eral or central in­tra­venous admin­istra­tion of mel­flu­fen in com­bi­na­tion with dexa­meth­a­sone in patients with re­lapsed re­frac­tory mul­ti­ple myeloma, RRMM. Up to 25 RRMM patients who have re­ceived at least two pre­vi­ous lines of ther­apy will be en­rolled.

"Patients who re­ceive anti-cancer treat­ment …

Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounces that the Com­pany submits a New Drug Appli­ca­tion (NDA) to the U.S. Food and Drug Admin­istra­tion, FDA, for ac­cel­er­ated ap­prov­al of mel­flu­fen (INN mel­phalan flufenamide) in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of adult patients with mul­ti­ple myeloma whose dis­ease is re­frac­tory to at least one pro­te­a­some in­hib­i­tor, one immuno­modu­la­tory agent and one anti-CD38 mono­clonal anti­body (i.e., triple-class re­frac­tory mul­ti­ple myeloma patients).

Melflufen is the lead can­di­date com­ing out of the Oncopeptides' pro­pri­e­tary PDC-platform. The prod­uct is a first-in-class aminopeptidase-targeting …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounces that patients in the OCEAN study stay on treat­ment longer than pre­vi­ously esti­mated. As a con­se­quence, top-line re­­sults are esti­mated for H1 2021 instead of pre­vi­ously com­mu­ni­cated Q4 2020. Patient recruitment in OCEAN will re­main open to ensure that the 339 dis­ease pro­gres­sion events needed to com­plete the study can be reached within a reason­able time­frame.

OCEAN is a ran­dom­ized, comparative study be­tween mel­flu­fen and poma­lido­mide in patients with re­lapsed re­frac­tory mul­ti­ple myeloma (RRMM). The patients en­rolled in the study have pre­vi­ously …