BioInvent tumbles on clinical hold
- Swedish-based BioInvent publicly announced Tuesday that the U.S. Food and Drug Administration has given verbal notice of a full clinical hold to be place on its lead candidate.
- No further patients will be dosed in the Phase 2 study of BI-505 in multiple myeloma patients. The drug is meant to deepen therapeutic response and delay onset of relapse in patients undergoing autologous stem cell transplant with high-dose melphalan.
- The company is waiting for a written notice to provide more detail, but has reported that the agency said the hold is due to "an adverse cardiopulmonary event in the clinical study."
"BioInvent will analyze the possibility to obtain release of the clinical hold and markets will be updated when there is further information to report," said the company on November 8.
It's not yet clear what will happen with BI-505, and the company does have other oncology drugs in or near the clinic to fall back on. Its anti-PIGF monoclonal antibody TB-403, in development with Oncurious, has moved into a Phase 1/2a study for the treatment of relapsed or refractory medulloblastoma, a rare childhood cancer. First results are expected in 2017. BI-1206, an anti-CD23b antibody, has potential as an add-on with rituximab to block resistance in Non-Hodgkin's lymphoma and chronic lymphocytic leukemia, and a Phase 1/2 is due to start by the end of the year.
However, as BioInvent's lead clinical candidate, the hold on BI-505 will be a blow, and the initial impact of the news was enough to make BioInvent's shares plunge, dropping more than 20% on the news.
- BioInvent Statement
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