- XBiotech (XBIT -18%) slips on triple normal volume, albeit on turnover of only 350K shares, in response to the company's disclosure that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has objections (requests) related to its Marketing Authorization Application (MAA) seeking approval of Xilonix for the treatment of advanced colorectal cancer, an accelerated review indication.
- According to CHMP's Day 180 List of Outstanding Issues, the committee cites clinical objections related to Xilonix's risk/benefit justification and pharmacokinetics. Quality objections cited relate to the qualification of the cell line used to produce the antibody and scaled down systems used to demonstrate the robustness of the purification process in addition to a clarification of process controls.
- The company believes CHMP's requests are addressable and it intends to submit its responses within 60 days.
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Xilonix is a True Human monoclonal antibody (IgG1k) that binds to interleukin-1 alpha, thereby blocking the inflammation that supports tumor growth, spread and symptomatic effects of the cancer.