A phase 2 study of the antibody BI-505 in patients with multiple myeloma (MM) has been placed on full clinical hold.
BioInvent International, the company developing BI-505, said it has received verbal notice of the clinical hold from the US Food and Drug Administration (FDA).
The clinical hold means no new subjects can be enrolled on the trial, and there can be no further dosing of subjects who are already enrolled.
BioInvent International said it has yet to receive written notice of the clinical hold from the FDA. However, based on verbal communications, the clinical hold is due to an adverse cardiopulmonary event.
The study (NCT02756728) is being conducted by BioInvent International in collaboration with investigators at the University of Pennsylvania.
The goal of the study is to determine if BI-505 can deepen therapeutic response and thereby prevent or delay relapse in MM patients undergoing autologous stem cell transplant with high-dose melphalan.
BioInvent International said it will analyze the possibility to obtain release of the clinical hold and will provide updates when there is further information to report.
About BI-505
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.
According to BioInvent International, the development strategy for BI-505 is focused on eliminating residual disease by combining the antibody with modern standard-of-care drugs used to treat MM.
The company said BI-505 proved safe in a phase 1 trial of patients with relapsed/refractory MM, as well as demonstrating “signs of a positive effect against the disease.” This study was published in Clinical Cancer Research in June 2015.
BI-505 has received orphan drug designation as a treatment for MM from both the FDA and the European Medicines Agency.
