BioInvent International has announced that the company and its partner, the University of Pennsylvania, have decided to expand their planned clinical Phase II study with the antibody BI-505 by, among other things, including a control group. This will increase the study data quality and accelerate the path for approval of a potential new drug for multiple myeloma.
“The interest that leading researchers and clinicians at the University of Pennsylvania are showing in this potentially groundbreaking treatment for multiple myeloma makes it possible to conduct the planned study in a time and cost efficient way. The increased patient numbers will not significantly impact the schedule nor BioInvent’s costs for the study,” says Michael Oredsson, President and CEO of BioInvent.
As a result of more effective treatments being available, the multiple myeloma survival rate has increased significantly over the past 20 years. However, neither existing nor new drugs in clinical development are expected to be able to eliminate all myeloma cells, and residual cells lead to relapse in the vast majority of patients with the disease. Data from preclinical studies indicate that the mechanism-of-action of BioInvent’s antibody BI-505, to engage the immune system to seek up and attack stressed cancer cells, has the potential to significantly improve responses and prevent or delay relapse. The positive safety profile of BI-505, which has been documented in an earlier clinical trial, is an important factor in making BI-505 well-suited for patients who are undergoing autologous stem cell transplant (ASCT).
The Phase II controlled study will include patients undergoing ASCT and chemotherapy with high-dose melphalan (HDM). The number of patients receiving supplementary treatment with BI-505 will be increased to 45 patients, up from the previously announced 30. In addition, a control group of a total of 45 patients will be added to the study. These patients will receive the standard of care treatment. Altogether the number of patients in the study is being tripled compared to the previously communicated plan. The greater patient numbers will allow for a more accurate evaluation of the effect of supplementary therapy with BioInvent’s antibody. The study will begin with a safety evaluation of five patients, which is in keeping with the original plan, and will also include an interim analysis.
The clinical effect of BI-505 will be evaluated 100 days after transplantation and after one year. All patients will also be monitored for up to five years to evaluate progression-free survival. Despite the more ambitious plan, it will be possible to initiate the study in accordance with the previously communicated schedule.
“We are enthusiastic about the potential for BI-505 to prevent or delay relapse of multiple myeloma. This new and more ambitious study design will generate robust clinical data, facilitating the future development of a new approach in myeloma for our patients.,” says Brendan Weiss, MD and Assistant Professor of Medicine at the University of Pennsylvania.