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 often get an implanted port, a type of central venous cath­e­ter placed under the skin, to limit the num­ber of needle sticks, facilitate in­tra­venous admin­istra­tion and en­hance con­ve­nience. The PORT study may provide an addi­tional op­tion in the way mel­flu­fen is de­liv­ered", says Klaas Bakker, CMO of Oncopeptides. "Broadening the mode of admin­istra­tion would allow physicians to choose the op­tion that is preferable for their patients".

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 on August 4, 2020 at 15.30 (CET).

About mel­flu­fen

Melflufen (INN mel­phalan flufenamide) is a first in class peptide-drug con­ju­gate (PDC) that targets aminopeptidases and rapidly re­leases al­kyl­at­ing agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is im­medi­ately hydrolyzed by peptidases to re­lease 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. In the pivotal phase 2 HORIZON study mel­flu­fen plus dexa­meth­a­sone dem­onstrated en­cour­ag­ing ef­fi­cacy and a clin­i­cally man­ageable safety profile in heavily pre­treated patients with re­lapsed re­frac­tory mul­ti­ple myeloma, with primarily hema­to­logic Adverse Events (AE) and a low in­ci­dence of non-hematologic AEs.

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 peptide-drug con­ju­gate (PDC) that targets aminopeptidases and rapidly re­leases al­kyl­at­ing agents into tumor cells. Melflufen (INN mel­phalan flufenamide) is in de­vel­op­ment as a new treat­ment for the hema­to­logical malig­nan­cy mul­ti­ple myeloma and is cur­rently being tested in mul­ti­ple clin­i­cal stud­ies in­clud­ing the pivotal phase 2 HORIZON study and the on­go­ing phase 3 OCEAN study. Based on the re­­sults from the HORIZON study Oncopeptides has sub­mitted a New Drug Appli­ca­tion (NDA) to the U.S. Food and Drug Admin­istra­tion, FDA, for ac­cel­er­ated ap­prov­al of mel­flu­fen in com­bi­na­tion with dexa­meth­a­sone for treat­ment of adult patients with triple-class re­frac­tory mul­ti­ple myeloma. Oncopeptides' global Headquarters is in Stock­holm, Sweden and the U.S. Headquarters is situated 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.