BioInvent International (BINV) announced that patient recruitment into the trial can now start in the upcoming clinical phase II study with the antibody BI-505 in patients with multiple myeloma, as necessary regulatory approvals have been obtained. The first patient is expected to be dosed in May.
Multiple myeloma is a bone marrow cancer which affects more than 120,000 people globally every year. Initial treatment is often successful, but unfortunately, most patients will relapse and in 2015, nearly 90,000 patients died as a result of the disease. BI-505 is a novel immuno-oncology treatment with the potential to prevent or delay relapse of multiple myeloma.
"The start of this phase II study is an important milestone in the development of BI-505, an antibody with the potential to offer multiple myeloma patients a longer and healthier life," says Anna Wickenberg, vice president of clinical development at BioInvent.
The clinical study will be conducted by BioInvent in collaboration with investigators at the University of Pennsylvania in the United States. It aims to document the ability of BI-505 to deepen the therapeutic response and thereby prevent or delay relapse of multiple myeloma in patients undergoing autologous stem cell transplantation (ASCT) with high-dose melphalan as part of their standard of care. The study will enroll approximately 90 patients undergoing ASCT whereof half will receive BI-505 as an add-on treatment to their standard of care.
The study is open-label, randomized, and includes a control group receiving only standard treatment. The open-label design will allow for patient outcomes to be monitored on an individual basis throughout the study. The primary efficacy evaluation of BI-505 will be made after 100 days with the primary endpoint being the proportion of patients in stringent complete response (sCR). Patients will thereafter be followed over three years to document progression-free survival (PFS). As a secondary endpoint, patients will also be monitored for any residual, disease known as "Minimal Residual Disease" (MRD), to assess deep responses.
BI-505 is a human antibody against ICAM-1 developed by BioInvent which will be clinically tested in cooperation with researchers at University of Pennsylvania as an immuno-oncological therapy to prevent or delay relapse in patients with multiple myeloma (a form of bone marrow cancer) undergoing stem-cell transplantation. Preclinical data indicates improved activity against myeloma when BI-505 is administered in combination with Velcade or Revlimid. BI-505’s favourable safety profile has been demonstrated in a previous phase I trial. This and the unique mechanism of action, “flagging” remaining myeloma cells for elimination by actively recruited macrophages, as well as the potential to inhibit ICAM-1 dependent survival signals between myeloma cells and tumour stroma, indicate a unique possibility of improving the therapeutic effect of stem-cell transplantation and other cancer therapies.