Date: 2015-03-19
Type of
information: Halting of the trial
phase: 2
Announcement: halting of the trial
Company: BioInvent (Sweden)
Product: BI-505
Action
mechanism:
- monoclonal antibody. BI-505 is a human antibody selected from the n-CoDeR®-library and fully owned by BioInvent. It is directed against the ICAM-1 adhesion protein, which is highly expressed on multiple myeloma cells. BI-505 has demonstrated significant anti-tumor activity in several relevant models of multiple myeloma.
Disease: smoldering multiple myeloma
Therapeutic
area: Cancer - Oncology
Country: Sweden
Trial
details:
- The study is a single-arm, open-label, phase 2 clinical trial with BI-505, in patients with smoldering multiple myeloma. It will include 10 patients in Sweden. The study evaluates disease activity following treatment with BI-505. Secondary objectives include safety, pharmacokinetics and assessment of biomarkers. (NCT01838369)
Latest
news:
- • On March 19, 2015, BioInvent International 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 multiple myeloma 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 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. As a consequence of this strategic analysis of the potential of BI-505 in multiple myeloma 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.
- • On April 22, 2013, BioInvent International has announced that the first patient has been treated in its phase II study of the drug candidate BI-505, developed for the treatment of multiple myeloma. The study is conducted in patients with asymptomatic myeloma (called “smoldering multiple myeloma”). Smoldering myeloma patients have not developed symptoms of disease and the condition can be detected only in laboratory tests. The current study involves up to 10 patients and evaluates disease activity following treatment with BI-505. Secondary objectives include safety, pharmacokinetics and assessment of biomarkers.
- • On January 7, 2013, the Swedish Medical Products Agency has approved the initiation of a phase 2 study evaluating disease response following treatment with BI-505, in patients with smoldering multiple myeloma. The study aims to assess the tumor response rate (defined according to the IMWG uniform response criteria). Secondary objectives of the trial includ to further assess clinical safety, pharmacokinetic profile, pharmacodynamics and immunogenicity profile of BI-505.
Is
general: Yes
