Oncopeptides AB (STO:ONCO), a Swedish biotech company focused on difficult-to-treat cancers, announced on Tuesday that the US Food and Drug Administration (FDA) has lifted the clinical hold on OPD5, its next-generation Peptide Drug Conjugate (PDC) therapy.

OPD5, a follow-on to Oncopeptides' flagship drug melflufen (branded Pepaxti in Europe), is designed to treat multiple myeloma with a potentially improved risk-benefit profile.

The company plans to advance OPD5 into clinical development, starting with the OP-502 study to assess its safety, tolerability and efficacy. Oncopeptides sees strong demand for PDC therapies in the United States and is exploring additional indications for OPD5 beyond multiple myeloma.

To support its next phase of development, including a Phase 1 study, the company is evaluating financing options such as strategic partnerships.