Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounces that the Com­pany 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 pro­pri­e­tary 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 a myeloablative regi­men fol­lowed by au­tol­o­gous stem cell trans­plan­ta­tion in patients with re­lapsed re­frac­tory mul­ti­ple myeloma. The spe­cif­ic for­mu­la­tion enables admin­istra­tion of high doses which pro­vides a clear rationale for treat­ment of this patient group.

"This is an im­por­tant mile­stone for Oncopeptides and enables us to fur­ther le­ver­age the PDC-platform and de­vel­op a po­ten­tial treat­ment for dis­eases where there is a sig­nif­i­cant unmet med­i­cal need", says Marty J Duvall, CEO of Oncopeptides AB. "We esti­mate to recruit the first patient in the phase 1 study in H1, 2021".

OPD5 is based on the pro­pri­e­tary PDC plat­form. Peptide-drug con­ju­gates le­ver­ages aminopeptidases and re­leases al­kyl­at­ing agents rapidly into tumor cells. Aminopeptidases are overexpressed in tumor cells and are even more pronounced in ad­vanced can­cers and tumors with a high mutational burden. Thus, targeting aminopeptidases re­sults in sel­ective ac­tiv­ity in can­cer cells, sparing healthy cells which leads to a stronger ben­e­fit-to-risk profile.

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.