PhaseBio Pharmaceuticals and BioVectra, a (CDMO), signed a commercial scale supply agreement for the production of bentracimab, PhaseBio’s lead product candidate currently in a global Phase III clinical trial. Bentracimab is a human monoclonal antibody fragment that in earlier clinical trials has shown immediate and sustained reversal of the antiplatelet effects of Brilinta® (ticagrelor).
BioVectra will provide its CDMO services for the manufacturing of the active pharmaceutical ingredient (API) of bentracimab for use in PhaseBio’s ongoing global clinical trials and for global commercial use upon regulatory approval. Utilizing an E.coli-based manufacturing process at its manufacturing site in Windsor, Nova Scotia, BioVectra recently completed the first GMP run of bentracimab at commercial scale. Going forward, PhaseBio plans to integrate API manufactured at commercial scale at BioVectra into the ongoing Phase IIb and Phase III REVERSE-IT clinical trials to support global regulatory filings.
“As we prepare for the next phase of growth for bentracimab, we’re pleased to sign this agreement with BioVectra for the commercial supply and development of our novel reversal agent,” said Jonathan P. Mow, CEO, of PhaseBio Pharmaceuticals. “Having recently expanded our global Phase III REVERSE-IT trial into Canada and the European Union, and with other countries on the horizon, the signing of this agreement and the completion of our first commercial-scale manufacturing run are important steps as we continue preparing our regulatory filings and commercialization efforts for bentracimab.”
Pending approval of the drug by regulators, the partnership is expected to enable PhaseBio to supply bentracimab at launch in the U.S. to trauma and critical care centers. Based on data from IQVIA®, PhaseBio believes that providing adequate bentracimab supply for initial stocking and demand-based reorders for these key centers will make bentracimab accessible to approximately 80% of the population in the U.S. who are prescribed P2Y12 inhibitors like ticagrelor.
