On June 8, 2022 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the first patient has been dosed in the expansion portion of the Phase I/II study of BT5528, Bicycle’s second-generation Bicycle Toxin Conjugate (BTC) targeting EphA2 (Press release, Bicycle Therapeutics, JUN 8, 2022, View Source [SID1234615755]).
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"We believe EphA2 is an attractive target for cytotoxin delivery and BT5528 has the potential to overcome the significant safety concerns seen with an antibody drug conjugate (ADC) approach to targeting EphA2," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We are pleased with the molecule’s emerging safety profile and early signs of anti-tumor activity and look forward to providing additional data from the completed Part A portion of the Phase I/II trial next quarter."
The Phase I/II multi-center, open-label trial comprises two parts: Part A, dose escalation and Part B, dose expansion. While Part A of the trial was designed to assess safety, pharmacokinetics and establish a Phase II dose, the dose expansion portion of the trial is primarily designed to assess the clinical activity of BT5528 at the recommended Phase II dose of 6.5mg/m2 every other week that was established in Part A. Up to 56 patients will be enrolled in the initial expansion cohorts, with the ability to further expand enrollment based on the results of the initial expansion cohorts. Dose expansion in urothelial and ovarian cancers will take place as the Company seeks to build on interim response data previously reported, as well as in a basket cohort of other solid tumors, including non-small cell lung cancer, triple-negative breast cancer, head and neck, and esophageal cancer.