CAMBRIDGE, England & BOSTON–(BUSINESS WIRE)–Bicycle Therapeutics plc (NASDAQ: BCYC) a clinical-stage biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles®) product platform, today announced that new translational data for BT1718 and preclinical data for BT5528 and BT8009 will be presented during poster sessions at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on October 26-30, 2019 in Boston, MA.
New translational data will be presented for BT1718, the Company’s lead Bicycle® Toxin Conjugate (BTC) product candidate, which define enrollment criteria for identifying expansion cohorts in the Phase IIa part of the ongoing Phase I/IIa trial with BT1718. The Phase I/IIa study, sponsored by Cancer Research UK, is currently in Phase I dose escalation in patients with advanced solid tumors who have not been pre-selected for MT1-MMP status. Once a recommended once-weekly Phase II dose is established, the Company expects to initiate the Phase IIa expansion, which will include patients determined to be MT1-MMP-postive based on a prespecified tumor membrane H-score. Initially, patients will be enrolled into two expansion cohorts, one in squamous lung cancer and the other in an all-comers “basket” cohort. Depending on results from these first two cohorts, additional cohorts may be initiated.
“We are creating a pipeline of Bicycle Toxin Conjugates, which selectively deliver toxin payload to tumors in a manner we believe is unique and differentiated to that of antibody drug conjugates,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “We intend to maximize chances of success in the clinic for these innovative medicines by applying well-validated translational approaches to inform tumor type selection and patient enrollment criteria. As the data to be presented supports, we believe we have developed a compelling rationale for the design of the Phase IIa part of the ongoing trial and look forward to advancing BT1718 into the expansion cohorts, following dose selection.”
Additional preclinical data will also be presented for Bicycle’s other BTC programs, BT5528 and BT8009, which show target-dependent anti-tumor activity across a range of EphA2-expressing and Nectin-4-expressing cancer models, respectively.