On February 26, 2021, PEPAXTO (melphalan flufenamide) in combination with dexamethasone was granted accelerated approval by the U.S. Food and Drug Administration, FDA, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. Following the approval PEPAXTO was included in the new Multiple Myeloma Clinical Practice Guidelines of the National Comprehensive Cancer Network® (NCCN) in Oncology, in the US.
On October 22, 2021, the company decided to withdraw PEPAXTO from the market in the US following data from the phase 3 OCEAN study which showed an overall survival in the ITT population with a HR of 1.104.
In January 2022, Oncopeptides rescinded the voluntary withdrawal of Pepaxto in the US. Further review and analyses of the heterogeneous overall survival data from the OCEAN study, and other relevant trials, made the company confident to reconsider the voluntary withdrawal. Pepaxto is once again an approved drug in the US. However, it will not be marketed until a mutual understanding on how to interpret the data has been reached with the FDA.
Melflufen is the first drug candidate coming out of the company´s proprietary Peptide Drug Conjugate platform, PDC. Oncopeptides is developing several new compounds based on the PDC platform. The FDA requested a clinical hold for melflufen on July 8, 2021.
Oncopeptides has a facility for pre-clinical drug development in Solna, Sweden, which provides adequate resources to further expand the development of the PDC-platform and generate new drug candidates.
Melflufen is our first in class anti-cancer PDC that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Aminopeptidases are a group of enzymes over expressed in tumor cells, including multiple myeloma cells. The binding of melflufen to aminopeptidases results in the release of a toxic payload that damages DNA and kills cancer cells.
Footprint in leading biotech hubs
The headquarters is in Stockholm, Sweden, and a modern pre-clinical drug development facility in Solna, outside Stockholm, Sweden.
Oncopeptides AB (publ) is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO.