BioInvent International (BINV) is planning to treat its first patient with multiple myeloma with BI-505, a human antibody against intercellular adhesion molecule 1 (ICAM-1), in an upcoming Phase II next month.
Multiple myeloma is a bone marrow cancer that affects more than 120,000 people worldwide every year.
BINV said that initial treatment of the disease is often successful, but most patients will relapse. Last year, the disease killed nearly 90,000 people.
BI-505 is a new immuno-oncology treatment that could help prevent or delay relapse of multiple myeloma. It will be clinically tested in collaboration with researchers at University of Pennsylvania, US.
Preclinical data has demonstrated better activity against myeloma when BI-505 is administered in combination with Velcade or Revlimid drugs.
To be conducted in the US, the upcoming clinical trial seeks to document the ability of BI-505 to deepen the therapeutic response and 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 open-label, randomised study will enrol around 90 patients undergoing ASCT whereof half will receive BI-505 as an add-on treatment to their standard of care.
A control group receiving only standard treatment will be included in the study, the open-label design of which will help patient outcomes to be monitored on an individual basis throughout the study.
The primary efficacy evaluation of BI-505 will be conducted after 100 days with the primary endpoint being the proportion of patients in stringent complete response (sCR).
Patients will then 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 evaluate deep responses.
Currently, BioInvent has three proprietary projects in or close to clinical development and partnership agreements with seven global pharmaceutical and biotech companies.