The U.S. Food and Drug Administration (FDA) has verbally notified BioInvent International that it’s placing a full clinical hold on the company’s Phase 2 trial evaluating BI-505 in multiple myeloma patients. This means Sweden-based BioInvent cannot dose trial patients while the hold is in place.
While the company has not yet received a written notice from the FDA, the FDA verbally informed BioInvent officers that the hold is due to a cardiopulmonary adverse event during the study, BioInvent reported in a press release.
The Phase 2 clinical trial (NCT02756728) is evaluating the effectiveness and safety of administering BI-505 in combination with high-dose Alkeran (melphalan) in up to 90 myeloma patients undergoing autologous stem cell transplant (ASCT).
Specifically, the trial is evaluating the ability of BI-505 in deepening the therapeutic response and prevent or delay relapse of patients undergoing ASCT and high-dose Alkeran (a chemotherapy drug approved to treat myeloma patients).
The study’s primary efficacy endpoint is the number of patients in stringent complete response (sCR), which will be assessed following 100 days of treatment with BI-505. Patients will be followed for about three years to assess progression-free survival (PFS), and will also be monitored for minimal residual disease (MRD), which will serve as one of the trial’s secondary endpoints.
BioInvent is conducting the clinical trial in collaboration with the University of Pennsylvania and the Abramson Cancer Center of Pennsylvania.
BioInvent will now review the clinical hold in hopes of continuing the trial, and will provide updates.
Multiple myeloma is a bone marrow cancer that affects more than 120,000 people globally every year. Initial treatment is often successful but most patients eventually relapse.
BI-505 is a novel immuno-oncology treatment with the potential to prevent or delay relapse of multiple myeloma. BI-505 selectively binds to the adhesion protein ICAM-1, which is normally expressed on leukocytes and endothelial cells (the cells lining blood vessels), and overexpressed in a variety of cancers including multiple myeloma.
BI-505’s favorable safety profile has been demonstrated in a Phase 1 clinical trial (NCT01025206). Results from the study showed that BI-505 can be safely administered at doses that saturate the ICAM-1 receptors of myeloma cells in advanced relapsed/refractory in multiple myeloma patients.
BI-505 was granted Orphan Drug Designation for multiple myeloma by both the FDA and European Medicines Agency (EMA).