multiple myeloma
BioInvent International has decided to terminate its phase 2 trial of the antibody BI-505 in patients with multiple myeloma (MM).
The decision follows a review and discussion with the US Food and Drug Administration (FDA), which put the trial on full clinical hold in November due to an adverse cardiopulmonary event.
The trial was designed to determine if BI-505 could deepen therapeutic response and thereby prevent or delay relapse in MM patients undergoing autologous stem cell transplant with high-dose melphalan.
The termination of this trial may not mean the end of BI-505. BioInvent is currently in discussions with the FDA about the potential to develop the drug for use in other patient populations.
BI-505 is a human antibody targeting ICAM-1, a protein that is elevated in MM cells. BI-505 has been shown to attack MM in 2 ways—by inducing apoptosis in MM cells and by engaging macrophages to attack and kill MM cells.
The development strategy for BI-505 has been focused on eliminating residual disease by combining the antibody with modern standard-of-care drugs used to treat MM.
BI-505 has orphan drug designation as a treatment for MM from both the FDA and the European Medicines Agency.
Results of a phase 1 trial of BI-505 in MM patients were published in Clinical Cancer Research in June 2015.
