- Bicycle Therapeutics plc BCYC has announced interim Phase 1 results from the Phase 1/2 trial of BT8009, a second-generation BTC targeting Nectin-4, in patients with advanced solid tumors.
- The data will be presented at the 2022 American Association for Cancer Research Annual Meeting.
- Patients were treated until disease progression or intolerable toxicity, with tumor assessments for response per RECIST taken every two months.
- One dose-limiting toxicity (Grade 3 abnormal physical weakness) was reported at the 7.5 mg/m2 weekly dose level. Six patients (18%) experienced an SAE, with only one related SAE (vomiting).
- Related: Bicycle Therapeutics Stock Falls After Interim Data Of Toxin Conjugates In Ovarian Cancer Trial.
- In the urothelial carcinoma (UC) 5 mg/m2 cohort, a 50% overall response rate and a 75% disease control rate were observed.
- 4/8 patients with a complete response (CR) or partial response (PR), including 1/8 patients with a CR and 3/8 patients with a PR, and 2/8 patients (25%) with stable disease (SD).
- BT8009 exhibits a promising preliminary tolerability profile and preliminary antitumor activity.
- The molecule will continue to be explored in the current dose-escalation/dose-expansion study of BT8009 monotherapy and combination with Bristol Myers Squibb Co's BMY Opdivo (nivolumab).
- Price Action: BCYC shares are up 25.40% at $47.34 during the market session on the last check Friday.
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