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bicycle therapeutics Bicycle Therapeutics Announces Interim BT5528 Phase I Clinical Trial Results and Preliminary Results from Ongoing BT8009 Phase I Clinical Trial October 7 , 2021 - BT5528 Phase I anti - tumor activity observed in late line patients , with 2 partial responses out of 2 urothelial cancer patients dosed and an 80 % disease control rate in 5 EphA2 - positive ovarian cancer patients , including 1 partial response - A recommended BT5528 Phase II dose ( RP2D ) range has been established at 6.5-8.5mg / m² every other week ; expansion cohorts expected to initiate in 2022 - In the ongoing BT8009 Phase I trial in monotherapy cohorts , 4 out of 11 urothelial patients had partial responses ; Phase I dose escalation remains ongoing , with no dose limiting toxicities ( DLTs ) yet observed - BT5528 data to be presented at a virtual plenary session today at 1:25 pm ET at the AACR - NCI - EORTC meeting ; conference call scheduled for 3:00 pm ET CAMBRIDGE , England & BOSTON -- ( BUSINESS WIRE ) -- Oct . 7 , 2021-- Bicycle Therapeutics plc ( NASDAQ : BCYC ) , a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide ( Bicycle® ) technology , today provided a clinical update of its wholly - owned , next - generation Bicycle Toxin Conjugates ( BTCs ) , reporting interim Phase I trial results for BT5528 and preliminary findings from the ongoing dose escalation portion of the BT8009 clinical trial . " We are pleased to provide a clinical update for two of our wholly - owned BTCS currently undergoing Phase 1 dose escalation trials in late line cancer patients , " said Dominic Smethurst , MA , MBChB , MRCP , MFPM , Chief Medical Officer of Bicycle Therapeutics . “ We are delighted to see preliminary anti - tumor activity in both trials and across two tumor types , as well as to report tolerability profiles that may demonstrate differentiation from antibody - based approaches . " " These data support our belief that the Bicycle platform offers a potentially differentiated approach to traditional toxin delivery . The data generated from these molecules provide a wealth of information and insights as we continue to expand the application of our technology and generate additional Bicycle - targeted therapeutics with the intention of making a meaningful difference to cancer patients , " said Kevin Lee , Ph.D. , Chief Executive Officer of Bicycle Therapeutics . " We look forward to providing additional clinical data on BT5528 and BT8009 next year , and initiating our Phase I / II study for BT7480 later this year . " BT5528 , a BTC targeting EphA2 , a target for which prior antibody - based approaches have been unsuccessful , has demonstrated preliminary anti - tumor activity . Bicycle has established an RP2D range and is pursuing enrollment in expansion cohorts • Preliminary signs of anti - tumor activity observed . A total of 24 patients were dosed both prior to , and after , the implementation of the EphA2 immunohistochemistry ( IHC ) assay , with a median of seven prior lines of therapy . Amongst these patients , preliminary anti - tumor activity was observed in urothelial and ovarian cancer patients . o A total of two BT5528 monotherapy urothelial patients were dosed . Both ( 100 % ) were observed to have tumor reductions constituting a partial response under Response Evaluation Criteria in Solid Tumors ( RECIST ) version 1.1 . The administered doses in these patients ranged from 6.5mg / m² to 10 mg / m² every other week . o A total of eight BT5528 monotherapy ovarian cancer patients were dosed . Of these eight , five were determined to be EphA2 - positive based on the IHC assay . Anti - tumor activity was observed in four of the five ( 80 % ) patients , including one ( 20 % ) that constituted a partial response under RECIST version 1.1 criteria . The range of administered doses in these patients was 6.5-8.5mg / m² every other week . • Doses of BT5528 administered to date have been tolerated in the ongoing Phase I portion of the Phase I / II trial . In addition , and in contrast to the toxicities observed with MedImmune's EphA2 antibody - drug conjugate ( ADC ) MEDI - 547 , Bicycle has observed no signs of coagulopathy to date . • Based on the Phase I results , Bicycle has established an RP2D range . BT5528 has been dosed up to 8.5mg / m² every week and 10mg / m² every other week . Some mild and transient neutropenia was observed at 8.5mg / m² every week , although this did not constitute a DLT . At 10mg / m² every other week , two DLTs were observed ( Grade 3 fatigue and Grade 3 pneumonitis ) . The most common Grade 3 and above events were neutropenia , anemia and pneumonitis and there were two Grade 5 events : tumor lysis syndrome and renal failure caused by GI - related dehydration . Based on the totality of the findings , the RP2D is expected to be in the range of 6.5 mg / m² to 8.5mg / m² every other week , a dose that is believed to