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Oncopeptides has submitted an IND application to FDA

Marty Duvall

Oncopeptides 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 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.

An important milestone

“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 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.

Photo of Marty Duvall: Oncopeptides