Announcement by the Bicycle therapeutics that the presentation at the ESMO 2019 Annual Congress of updated data from the Phase I / IIa trial evaluating BT1718 in patients with advanced solid tumors

Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology firm pioneering a new therapeutic class based on its proprietary bicyclic peptide (Bicycles ®) product platform, announced today the introduction of updated information from a Phase I / IIa trial in cooperation with Cancer Research UK as well as the evaluation of BT1718 in an unselected group of sophisticated solid tumor patients. The findings will be submitted today at a poster session at the European Society of Medical Oncology (ESMO) 2019 Annual Congress in Barcelona, Spain, from 12:00-13:00 CET by Natalie Cook, Ph.D., a research researcher and senior clinical lecturer at the University of Manchester.

Patients were assessed for anti-tumor activity, safety and pharmacokinetics in the Phase I dose escalation up to the data cut-off of 7 August 2019. Based on data from patients in cohorts across dose levels tested, many of which are below the predicted therapeutic range, 13 of 24 evaluable patients (54%) had stable disease at the eight-week timepoint, including a patient who experienced a 45% reduction in a target lesion. Patients were assessed for anti-tumor activity, safety and pharmacokinetics in the Phase I dose escalation up to the data cut-off of 7 August 2019. BT1718 appeared to be tolerable with manageable adverse events with once-weekly dosing, which is the expected schedule for the Phase IIa portion of the study. BT1718 appeared to be tolerable with manageable adverse events with once-weekly dosing, which is the expected schedule for the Phase IIa portion of the study.

The Phase I / IIa study of BT1718 is sponsored by Cancer Research UK. The primary goal of the Phase I dose escalation portion of the study is to select the recommended Phase II dose (RP2D) by setting the maximum tolerated dose and maximum administered dose and also to evaluate the safety and toxicity profile of BT1718 in patients with advanced solid tumors. The Phase IIa portion of the study, consisting of up to four cohorts in selected indications expressing MT1-MMP, will be initiated after the selection of the one-weekly RP2D.

,