- Bicycle Therapeutics plc (NASDAQ:BCYC) has reported interim Phase I trial results for BT5528 and preliminary findings from the ongoing dose-escalation portion of the BT8009 trial.
- Two BT5528 monotherapy urothelial patients were dosed. Both were observed to have tumor reductions constituting a partial response.
- The administered doses in these patients ranged from 6.5mg/m2 to 10 mg/m2 every other week.
- Eight BT5528 monotherapy ovarian cancer patients were dosed.
- Anti-tumor activity was observed in 4 of 5 patients, including one partial response.
- The range of administered doses in these patients was 6.5- 8.5mg/m2 every other week. Bicycle has observed no signs of coagulopathy to date.
- Some mild and transient neutropenia was observed at 8.5mg/m2 every week, although this did not constitute dose-limiting toxicity.
- Bicycle plans to initiate expansion cohorts for BT5528 with 56 patients in 2022.
- The Company also presented preliminary data from the Phase 1 portion of its Phase 1/2 trial of BT8009.
- Four patients dosed at 2.5mg/m2 were observed to have tumor reductions, including partial responses, with tumor reductions between 37% to 89%.
- Seven response evaluable patients were dosed at 5.0mg/m2 weekly.
- Five were observed to have at least stable disease, with a disease control rate of 71%, and three patients were observed to have tumor reductions between 44% to 89%.
- Related: Bicycle, Ionis To Develop Targeted Oligonucleotide Therapeutics.
- Price Action: BCYC shares are down 12% at $36.69 during the market session on the last check Thursday.
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