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

Thursday, March 19, 2015

Lund, Sweden – 19 March, 2015 – BioInvent International AB (OMXS: BINV) completed a strategic analysis of its ICAM-1 targeted phase II antibody BI-505 with thought leaders to garner support on the development of BI-505.
Based on the analysis of BI-505’s data, a clear direction emerged that BI-505 is uniquely positioned to increase the potential depth and quality of response in patients receiving standard of care treatment for multiple myeloma. Many MM patients initially achieve a good response from existing therapy; however, patients can eventually relapse and succumb to the cancer as a consequence of myeloma cells that remain in the patient after treatment (minimal residual disease).
BioInvent intends to conduct a Phase IIa study in MM 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.
“There is a great need within the multiple myeloma patient population for targeted treatment options which could deepen the responses that can be achieved with currently available treatments. BI-505 has a unique mechanism of action which could target residual disease that eventually leads to relapse in this population, and the planed study will address this hypothesis”, said Brendan Weiss MD an Assistant Professor of Medicine at the University of Pennsylvania in Philadelphia.

“BI-505 may be uniquely positioned to prevent or delay relapse of multiple myeloma. This patient need is currently not addressed effectively by other treatment options and relapse eventually occurs in patients. We are delighted with the opportunity to conduct a clinical study with the University of Pennsylvania prior to progressing to a larger clinical trial”, stated Michael Oredsson, President and CEO of BioInvent.

As a consequence of this strategic analysis of the potential of BI-505 in MM patients post ASCT, BioInvent will conclude the its smouldering 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.