Bicycle Therapeutics spins up on positive trial of BT8009

Anglo-American biotech firm Bicycle Therapeutics’ (Nasdaq: BCYC) shares leapt 24.5% by close of trading on Friday, and a further 6.4% to $50.00 in after-hours activity, as it announced positive interim Phase I results from the Phase I/II trial of BT8009, a second-generation BTC targeting Nectin-4, to be released at the 2022 American Association for Cancer Research Annual Meeting in New Orleans, LA.

"Since our initial BT8009 Phase I/II trial interim results last year, we are encouraged to see BT8009’s promising profile endure over time. Over the last six months, the preliminary anti-tumor findings have been confirmed, the initial responses have deepened and remained durable, and the tolerability profile remains unchanged," said Dominic Smethurst, chief medical officer of Bicycle Therapeutics, adding: "We believe BT8009 has the potential to offer clinically meaningful differentiation compared to currently available therapies and we look forward to advancing the program once the escalation phase is complete."

"As previously hypothesized, we believe that the differentiated pharmacokinetic profile of BTCs has the potential to deliver improved outcomes for patients and it is pleasing to see these clinical data mature and with it, the promise for a potentially industry-leading product profile," said Kevin Lee, chief executive. "We look forward to providing additional updates on BT8009 as well as updates from our broad Bicycle oncology pipeline this year."

As of March 7, 2022, 37 patients have been dosed in the Phase I/II trial of BT8009. A total of 12 response evaluable urothelial cancer (UC) patients have been dosed in monotherapy cohorts of 2.5mg/m2 and 5.0mg/m2 weekly in the ongoing trial.