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 been treated with at least an immunomodulator (IMiD) and a pro­te­a­some in­hib­i­tor (PI) and have all devel­oped re­sis­tance to their last line of ther­apy and to lena­lido­mide (IMiD), the most commonly used drug for the treat­ment of mul­ti­ple myeloma. The pri­mary end­point of the phase 3 study is Progression Free Survival (PFS). The re­­sults will be eval­u­ated once 339 patients have progressed in their dis­ease.

"A recent analysis in­di­cates that patients en­rolled in the OCEAN-study con­tinue treat­ment for a longer period of time than originally esti­mated, which speaks to the poten­tial ben­e­fit patients can have by participating in this trial", says Jakob Lindberg, CEO of Oncopeptides. "However, this most likely in­creases the time re­quired to reach the num­ber of dis­ease pro­gres­sion events needed to com­plete the study. We will con­tinue patient en­roll­ment to enable an analysis of re­­sults within a reason­able time­frame."

Oncopeptides is preparing an appli­ca­tion for ac­cel­er­ated ap­prov­al in Q2 2020 based on the re­­sults from the on­go­ing pivotal phase 2 study HORIZON, eval­u­ating mel­flu­fen in RRMM patients. Data from the pivotal phase 3 study OCEAN, will form the basis for a sub­mission of a supple­mental New Drug Appli­ca­tion (sNDA) to the US FDA in H2 2021, followed by a sub­mission of a Marketing Authori­za­tion Appli­ca­tion (MAA) in Europe.

The in­for­ma­tion in the press re­lease is in­for­ma­tion that Oncopeptides is obliged to make pub­lic pur­su­ant to the EU Market Abuse Regulation. The in­for­ma­tion was sub­mitted for pub­li­ca­tion, through the agency of the contact person above, on June 1, 2020 at 08.00 (CET).

About mel­flu­fen

Melflufen (melphalan flufenamide) is a first-in-class anti-cancer peptide-drug con­ju­gate that rapidly de­livers an al­kyl­at­ing pay­load into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is im­medi­ately cleaved by peptidases to de­liver an entrapped hydrophilic al­kyl­ator pay­load. Peptidases play a key role in pro­tein homeo­stasis and feature in cel­lu­lar processes such as cell-cycle pro­gres­sion and pro­grammed cell death. In vitro, mel­flu­fen is 50-fold more potent in myeloma cells than the al­kyl­ator pay­load itself due to the in­creased intracellular al­kyl­ator con­cen­tra­tion. Melflufen dis­plays cyto­toxic ac­­tiv­ity against myeloma cell lines re­sis­tant to other treat­ments, in­clud­ing al­kyl­ators, and has also dem­onstrated in­hib­ition of DNA repair induction and angiogenesis in pre­clin­i­cal stud­ies.

About Oncopeptides

Oncopeptides is a pharma­ceu­tical com­pany focused on the de­vel­op­ment of targeted ther­a­pies for dif­fi­cult-to-treat hema­to­logical dis­eases. The com­pany is focusing on the de­vel­op­ment of the lead prod­uct can­di­date mel­flu­fen (melphalan flufenamide), a first-in-class anti-cancer peptide-drug con­ju­gate that rapidly de­livers an al­kyl­at­ing pay­load into tumor cells. Melflufen is in de­vel­op­ment as a new treat­ment for the hema­to­logical can­cer mul­ti­ple myeloma and is cur­rently being eval­u­ated in mul­ti­ple clin­i­cal stud­ies in­clud­ing the pivotal phase 2 HORIZON study and the on­go­ing phase 3 OCEAN study. Oncopeptides' head­quar­ters is in Stock­holm, Sweden with U.S. head­quar­ters in Boston, Mass. The com­pany is listed in the Mid Cap segment on Nasdaq Stock­holm with the ticker ONCO.

More in­for­ma­tion is avail­able on www.oncopeptides.com.

Source: Oncopeptides.