Cyclacel(US:CYCC)2025-06-18 11:22Fadra (Fadraciclib) Development - Cyclacel is developing fadraciclib, a next-generation CDK2/9 inhibitor, with a precision medicine strategy in Phase 2 trials[3] - Phase 2 cohorts are enrolling patients with solid tumors with CDKN2A/CDKN2B abnormalities and T-cell lymphoma, with readouts expected in 2H 2024 and 2H 2024-1H 2025, respectively[3] - In a Phase 1 dose escalation study, 11 patients had CDKN2A/B abnormalities[12] - One endometrial cancer patient with CDKN2A, CDKN2B, and MTAP loss achieved a complete response (CR) with fadraciclib at 213mg QD[13] - In an oral Phase 1 dose escalation study (065-101), out of 32 patients, 2 achieved partial responses (PR), 21 had stable disease (SD), and 9 had progressive disease (PD)[17, 18] - In an expansion cohort of 12 patients, 7 (58.3%) experienced at least one related treatment-emergent adverse event (TEAE) of any grade, with most being Grade 1 or 2[34] - In the expansion cohorts, the overall response rate (ORR) was 8%, with a disease control rate (DCR) of 67%[35] Plogosertib (CYC140) Development - Plogosertib (CYC140) is a next-generation PLK1 inhibitor with a novel mechanism of action targeting ARID1A and TP53 mutated cancers[42, 44] - Preclinical data shows anti-cancer activity in 5 out of 13 solid tumors[43] - A Phase 1/2 clinical study (140-101) is ongoing in solid tumors and lymphoma, with dose escalation up to Dose Level 5 showing good tolerability and no dose-limiting toxicities observed to date[55, 57] - In vitro studies of 16 CRC PDX models showed that 5 models had an EC50 < 30 nM to plogosertib[65, 67] Financial Status - As of June 30, 2024, Cyclacel had $6.0 million in cash equivalents[82]