Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounces a suc­cess­ful com­ple­tion of en­roll­ment in the pivotal phase 3 study OCEAN for the treat­ment of re­lapsed re­frac­tory mul­ti­ple myeloma. The study in­cludes 450 patients from more than 100 hos­pi­tals around the world. Top line re­­sults are ex­pected to be pre­sented later this year.

OCEAN is a ran­dom­ized, comparative study be­tween mel­flu­fen and poma­lido­mide in patients with re­lapsed re­frac­tory mul­ti­ple myeloma (RRMM). The patients have been treated with immuno­modu­la­tory in­hib­i­tors (IMiD) and pro­te­a­some in­hib­i­tors (PI), they have devel­oped re­sis­tance to their last line of ther­apy and are re­frac­tory to lena­lido­mide (IMiD), the most commonly used drug for the treat­ment of mul­ti­ple myeloma. The pri­mary end­point is Progression Free Survival (PFS).

"I am very pleased to an­nounce that we man­aged to com­plete en­roll­ment in the OCEAN study de­spite the strenuous situation that our re­search and health­care providers cur­rent are facing. A pos­i­tive OCEAN comparison be­tween mel­flu­fen and the stan­dard of care in RRMM will provide crit­i­cal insights on how to op­ti­mize treat­ment of RRMM patients," says Jakob Lindberg, CEO of Oncopeptides. "This comparison will enable us to file for label ex­pan­sion of mel­flu­fen in the US and submit for regu­la­tory ap­prov­al in the EU and the rest of world".

As pre­vi­ously com­mu­ni­cated Oncopetides 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. Recently an­nounced top­line re­­sults from HORIZON dem­onstrate an Over­all Re­sponse Rate of 26% in triple-class re­frac­tory patients.

Oncopeptides ex­pects to present top line re­­sults from OCEAN later this year. Based on these pivotal phase 3 data, the Com­pany in­tends to submit a supple­mental New Drug Appli­ca­tion (sNDA) to the US FDA in Q2 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 May 22, 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, a first-in-class anti-cancer peptide-drug con­ju­gate that rapidly de­livers an al­kyl­at­ing pay­load into tumor cells. Melflufen (melphalan flufenamide) is in de­vel­op­ment as a new treat­ment for the hema­to­logical can­cer mul­ti­ple myeloma and is cur­rent 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.