Benzinga | Nov 4, 2021 07:14AM EDT

Bicycle Therapeutics Announces First Patient Dosed In Phase I/II Trial Of Bicycle Tumor-targeted Immune Cell Agonist BT7480 In Patients With Advanced Solid Tumors Associated With Nectin-4 Expression

Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle(r)) technology, today announced that the first patient has been dosed in the Phase I dose escalation portion of a company-sponsored Phase I/II trial of BT7480, a novel, fully synthetic Bicycle tumor-targeted immune cell agonist(tm) (Bicycle TICA(tm)) targeting Nectin-4 and agonizing CD137. Preclinical studies have demonstrated that BT7480 activates CD137 only in the presence of Nectin-4 expressing tumor cells. The Phase I/II trial of BT7480 will be conducted in patients with advanced solid tumors associated with Nectin-4 expression.

"BT7480 is our first Bicycle TICA to enter the clinic and is one of a new class of tumor-targeting agents," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "Overexpression of Nectin-4, a well-validated tumor antigen, has been observed in several common tumor types and is associated with poor disease prognosis. Activation of CD137, a co-stimulatory receptor expressed on multiple components of the immune system, can drive anti-tumor immunity, but activation outside of the tumor may give rise to toxicity. Preclinical studies have shown encouraging results, and we look forward to studying the safety and efficacy of this unique asset as we begin the dose escalation portion of the trial."

The Phase I/II multi-center, open-label trial will evaluate BT7480 administered once weekly. Enrollment is ongoing in the Phase I dose escalation of BT7480 given as a monotherapy, and the Company plans to evaluate BT7480 dosed in combination with nivolumab in future Phase I dose escalation cohorts. The Phase I portion of the trial is primarily designed to assess the safety and tolerability of BT7480, and to determine a recommended Phase II dose (RP2D). Following selection of an RP2D, Bicycle expects to initiate a Phase II dose expansion portion with the primary objective of evaluating the clinical activity of BT7480 as monotherapy and in combination with nivolumab in patients with Nectin-4-positive tumors.