Cyclacel(US:CYCC)2022-03-20 10:09Company Overview - Cyclacel is focused on converting cell cycle control biology into innovative oncology medicines[4] - The company has assets in mid-stage development targeting CDK2/9 and PLK1[4] - Cyclacel held a cash position of $40.2 million as of September 30, 2021, expected to finance operations through early 2023[4, 10] Clinical Programs - Fadraciclib (CYC065) is an oral CDK2/9 inhibitor with ongoing Phase 1/2 studies in solid tumors and leukemias, with data expected in 1H 2022 and 2H 2022 respectively[4] - CYC140 is an oral PLK1 inhibitor with IND cleared and Phase 1/2 in solid tumors to initiate in 1H 2022, with data expected in 1H 2023[4] - Fadraciclib has shown durable MCL1 suppression and anticancer activity in patients[7] Therapeutic Strategy - The company's therapeutic strategy involves suppressing multiple redundant mechanisms with a single drug to durably suppress cancer-promoting proteins/genes, enabling apoptosis[6] - Fadraciclib's mechanism of action includes durable suppression of anti-apoptotic proteins like MCL1, MYC, cyclin E, and KRAS mutant[12] - CYC140 has shown compelling preclinical data in liquid and solid cancers, including KRAS mutated cancers[7] Market Potential - Fadraciclib potentially addresses large markets, such as high-grade serous ovarian cancer where CCNE1 is amplified in over 20% of patients[28] - CCNE1 is amplified in 20% of high-grade serous endometrial/uterine cancers, which represents approximately 5,000 US incidence and 77,000 prevalence[28] - In breast cancer, CCNE1 is amplified in 30% of HR+ cases (56,000 US incidence, 735,000 prevalence) and 40% of BRCA1/2+ cases (18,000 US incidence, 238,000 prevalence)[28]