The trial will test whether the drug deepens the response of post-transplant myeloma patients.
Here is an excerpt from the press release:
BioInvent intends to conduct a Phase IIa study in multiple myeloma patients that have undergone autologous stem cell transplantation (ASCT) to investigate the ability of BI-505 to increase the depth and quality of response after ASCT in combination with standard of care. Results from the open-label trial will be compared to a historical data from a matched cohort of patients. The intention is to recruit approximately 30 patients, and study start is planned for early 2016. The study will be conducted as an investigator sponsored study in close collaboration with leading clinicians at the Abramson Cancer Center of the, University of Pennsylvania."
The press release also notes that the company no longer plans to pursue development of the drug for use in smoldering myeloma patients:
As a consequence of this strategic analysis of the potential of BI-505 in multiple myeloma patients post ASCT, BioInvent will conclude the its smoldering myeloma study. Smouldering myeloma does not constitute a relevant commercial development opportunity for BioInvent, and the mechanism of action of BI-505 is not believed to be as relevant in this indication."
The design of the new BI-505 trial is novel in several ways.
First, the patient group for the trial is unusual. Usually, a potential myeloma therapy is tested in relapsed myeloma patients in both Phase 1 and Phase 2 trials. If the development of the drug for relapsed myeloma goes well in both those initial phases, trials are then planned to test the drug in newly diagnosed patients.
In the case of BI-505, however, the drug was only tested in a Phase 1 trial in relapsed myeloma (see below). Instead of testing the drug further in a (larger) Phase 2 trial, also in relapsed myeloma, the company is switching gears and testing the drug in post-transplant patients – many of whom probably have never relapsed.
Second, the trial is an investigator-sponsored trial, meaning that the company developing BI-505 is not providing as much funding for the trial as would be the case if it were a company-sponsored trial.
Results of a Phase 1 trial testing BI-505 in heavily pretreated myeloma patients were published last month. Patients in the trial had a median of six prior therapies. The best response seen in the trial participants was stable disease; there were no partial responses, very good partial responses, etc. See this journal article for more details:
M Hansson et al, "A phase 1 dose-escalation study of antibody BI-505 in relapsed / refractory multiple myeloma," Clinical Cancer Research, Feb 2015 (link to abstract and full text of article)
You can view the full text of today's press release about the planned BI-505 trial in post-SCT myeloma patients here:
"BioInvent Confirms Clinical Strategy For BI-505 And Plans To Conduct Phase IIa Trial In Multiple Myeloma Post-Stem Cell Transplant Patients In The US," BioInvent press release issued Mar 19, 2015.
The Beacon also has published a few news articles in the past about BI-505. You can view them at this link.
