Bicycle Therapeutics(US:BCYC)2025-05-01 15:04Zelenectide Pevedotin (Nectin-4 Targeting Bicycle Drug Conjugate) - In the Duravelo-1 Ph1 study, 45% ORR (17/38) was observed in 2L+ EV-naïve mUC patients treated with zelenectide [26] - In the Duravelo-1 Ph1 study, 65% ORR (13/20) was observed in 1L cisplatin-ineligible mUC patients treated with zelenectide + pembrolizumab [38] - In TNBC patients with NECTIN4 gene amplification, 57% ORR (4/7) and 100% DCR (7/7) were observed with zelenectide monotherapy [56] - In NSCLC patients with NECTIN4 gene amplification, 40% ORR (2/5) and 100% DCR (5/5) were observed with zelenectide monotherapy [56] - The company plans to initiate the Duravelo-4 trial in NECTIN4-amplified NSCLC and the Duravelo-5 trial in NECTIN4-amplified multi-tumor in 2H 2025 [63] BT5528 (EphA2 Targeting Bicycle Drug Conjugate) - In all cancers, 12% ORR (14/113) was observed with BT5528 monotherapy at 6.5 mg/m2 Q2W dose esc+exp [120] - In urothelial cancer, 34% ORR (10/29) was observed with BT5528 monotherapy at 6.5 mg/m2 Q2W dose esc+exp [120] - BT5528 delivers 10x more drug to the tumor compared to plasma in patients [114] BT7480 (Tumor-Targeted Immune Cell Agonist) - 49% of patients experienced any grade treatment-related AEs (TRAEs) with BT7480, the most common being fatigue (23%) and headache (10%) [159] - 5% ORR (2/40) was observed with BT7480 in all patients [161] Financial Position - The company had $793 million in cash and cash equivalents as of March 31, 2025, with expected financial runway into 2H 2027 [6]