Bioinvent back to drawing board as it pulls trial of lead drug for myeloma

FDA sign

Swedish biotech BioInvent's worst fears have been realized after it was forced to terminate a trial of its lead drug—multiple myeloma therapy BI-505.

Last month, shares in BioInvent were hammered after the FDA told it to stop dosing patients in its Phase II trial of BI-505. The clinical hold was imposed after an adverse cardiopulmonary event was seen in a patient receiving the anti-ICAM1 antibody. 

The company said in a short statement that after discussions with the FDA it had decided to terminate the BI-505 trial, which was being conducted in a specific population of multiple myeloma patients undergoing autologous stem cell transplantation with high-dose melphalan.


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Shares in the company lost 12% of their value in the wake of the announcement, which comes after a string of other pipeline setbacks in the last few years, including the abandonment of BI-505 as a treatment for smoldering multiple myeloma (SMM) and solid tumors, and the failure of its BI-204 candidate for atherosclerosis and anticoagulant TB-402 in 2012. 

The development dashes BioInvent's hopes of signing up a development partner for BI-505 and means that its focus now will shift to other immuno-oncology candidates in its pipeline. 

Top of the list is Oncurious-partnered TB-403, an anti-placental growth factor (PlGF) antibody—originally developed and dropped by Roche—which is currently in a Phase I/II trial in rare pediatric cancers including medulloblastoma and neurosarcoma. 

Following a little behind is BI-1206 which is in Phase I/II for non-Hodgkin's lymphoma (NHL) and chronic lymphatic leukemia (CLL), while the company retains a 40% ownership in THR-317, an antibody for patients suffering from diabetic macular edema which ThromboGenics is testing in early-stage trials. 

The company—which is listed on the Stockholm Stock Exchange—said in October it is sitting on liquid funds of around $21 million, and has revenue streams to help offset the cash burn in its R&D projects. It recently signed development and manufacturing service deals with two separate clients expected to bring in around $3 million in revenues in 2016 and 2017.

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