The Fly

Bicycle says BT8009 exhibits potential best-in-class ant-tumor activivity

Bicycle Therapeutics announced updates from the Phase I/II trial of BT8009 in patients with numerous cancer types where Nectin-4 is expressed. BT8009 is a potential first in class Bicycle Toxin Conjugate BTC targeting Nectin-4, a protein located on the surface of cells that is highly expressed in urothelial cancer and other solid tumors. "Dosing our first patient in the Phase II expansion portion of the BT8009 trial is a key development milestone for Bicycle," said Kevin Lee, Ph.D., Chief Executive Officer. "Based on the data presented to date, we believe we are making an important step towards hopefully providing a clinically meaningful, differentiated therapy compared to what is currently available for UC as well as for other tumors that express Nectin-4, such as non-small cell lung cancer." "The results from the Phase I dose escalation portion of the BT8009 Phase I/II trial are very encouraging and we are excited to move rapidly forward with the dose expansion portion of the trial," said Dominic Smethurst, MRCP, Chief Medical Officer of Bicycle Therapeutics. "BT8009 continues to exhibit potential best-in-class anti-tumor activity and a favorable tolerability profile, with a confirmed overall response rate from the latest cohorts consistent with previous findings from the trial, and we are pleased to see UC patients at the 5mg/m2 dose remaining on therapy and continuing to respond. We are also pleased to report a confirmed partial response in an NSCLC patient and look forward to providing additional data from the Phase I escalation cohorts at a medical meeting in the first half of 2023."

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