On November 13, 2019 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) technology, reported that the first patient has been dosed in the Phase I dose escalation of its Phase I/II study of BT5528, a Bicycle Toxin Conjugate (BTC) targeting tumor antigen EphA2, in patients with advanced solid tumors associated with EphA2 expression (Press release, Bicycle Therapeutics, NOV 13, 2019, View Source [SID1234551172]). BT5528 is a second-generation BTC, which uses a valine-citrulline cleavable linker and a cytotoxin MMAE payload.
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"The initiation of this trial is an important step for Bicycle as BT5528 is our first U.S. investigational new drug (IND), and this is the first clinical study to be sponsored by the Company," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "BT5528 is also the first of our second-generation BTCs to enter the clinic and has demonstrated promising anti-tumor activity and tolerability across a broad range of preclinical studies. Notably, unlike existing EphA2-targeting antibody drug conjugates, BT5528 did not show coagulopathy in preclinical studies, and the first clinical dose has been well tolerated. We are pleased to have achieved another milestone in progressing our pipeline based on our novel and differentiated Bicycle technology, which we believe could generate potential first-in-class treatment options for patients suffering from cancer and other serious diseases."
The Phase I/II multi-center, open-label trial will evaluate BT5528 administered once-weekly as a single agent and in combination with nivolumab. The Phase I portion is a dose escalation primarily designed to assess the safety and tolerability of BT5528 and to determine a recommended Phase II dose (RP2D). Following selection of an RP2D, a Phase II dose expansion portion will be initiated with the primary objective of evaluating the clinical activity of BT5528. The study will be conducted across sites in the U.S. and the UK.