Therapy Areas: Respiratory
First Patient Dosed in Expansion Cohorts of Phase I/II Trial of Bicycle Toxin Conjugate BT5528 in Patients with Advanced Solid Tumors Associated with EphA2 Expression
10 June 2022 - - The first patient has been dosed in the expansion portion of the Phase I/II study of BT5528, UK-based biotechnology company Bicycle Therapeutics plc's (NASDAQ: BCYC) second-generation Bicycle Toxin Conjugate targeting EphA2, the company said.

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.

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing therapeutics. 

Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry.

This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development.

Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate targeting EphA2; BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle TICA targeting Nectin-4 and agonizing CD137, in company-sponsored Phase I/II trials.

In addition, BT1718, a BTC that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Cancer Research UK Centre for Drug Development.

Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, Massachusetts.


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