On October 19, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) reported 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) (Press release, Oncopeptides, OCT 19, 2020, View Source [SID1234568611]).

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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.