On September 21, 2020 Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC) (Nasdaq: CYCCP) (Cyclacel or the Company), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that an abstract highlighting clinical data with Cyclacel’s CDK2/9 inhibitor fadraciclib has been selected for an oral presentation at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium 2020 being held virtually on October 24 – 25, 2020 (Press release, Cyclacel, SEP 21, 2020, View Source [SID1234565436]). The data is from an ongoing Phase 1 study of fadraciclib as a single agent in patients with advanced solid tumors.
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Details for the presentations are as follows:
Title: Phase 1 safety, pharmacokinetic and pharmacodynamic study of fadraciclib (CYC065), a cyclin dependent kinase inhibitor, in patients with advanced cancers (NCT02552953)
Session Title: Late Breaking and Best Proffered Papers
Session Date and Time: Saturday 24 October 15:05 CET
Presentation Number: ORAL-002
The program can be accessed through the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) website.
About Cyclin-Dependent Kinases and Fadraciclib
Cyclin-dependent kinases (CDKs) are critical for cell cycle regulation and transcriptional elongation. Dysregulated CDKs have been linked to the cancer hallmarks of uncontrolled proliferation and increased survival. Fadraciclib (CYC065) is a potent orally and intravenously available inhibitor of CDK2 and CDK9.
In part 1 of a Phase 1, first-in-human study of fadraciclib as a single agent in patients with advanced solid tumors, target engagement and durable suppression of the MCL1 biomarker were observed after a single dose of fadraciclib. Tumor shrinkage and stable disease were observed in five patients with cyclin E, MCL1 and/or MYC amplified cancers.
The ongoing part 2 of the study is evaluating a more intensive dosing regimen than part 1. A heavily pretreated patient with MCL1 amplified endometrial cancer achieved a radiographically confirmed partial response (PR) after a month and a half on fadraciclib. Fadraciclib is also being evaluated in Phase 1 combination studies with venetoclax in patients with relapsed or refractory CLL and AML/MDS.
Preclinical data suggest that fadraciclib may benefit patients with adult and pediatric hematological malignancies such as AML, ALL, B-cell lymphomas, CLL, multiple myeloma and certain cyclin E-addicted or MYC-amplified solid tumors, including certain forms of breast cancer, neuroblastoma, ovarian cancer and uterine serous carcinoma.