Cyclacel Pharmaceuticals, Inc. announced that new clinical, pharmacokinetic (PK) and pharmacodynamic (PD) data from the CYC065-101 study of fadraciclib as monotherapy was selected by the Scientific Program Committee for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting from May 31-June 4, 2024 in Chicago. Details of the presentations are as follows: A phase 1 study evaluating the safety, pharmacokinetics, and efficacy of fadraciclib, an oral CDK2/9 inhibitor, in patients with advanced solid tumors and lymphoma. The Phase 2 part of the 065-101 study is designed to further evaluate fadra safety and efficacy in up to 8 cohorts defined by histology and/or NGS.

The study is powered to demonstrate response in the molecular subtype suggested by the Phase 1 data and others that may be sensitive. CDKN2A, CDKN2B deletions: CDKN2A gene deletions occur in over 10% of several solid tumors, including glioma, head and neck, pancreatic, esophageal, sarcoma, hepatobiliary, breast, melanoma, sarcoma, and others. In addition, CDKN2A deletions have been reported in 46% of patients with PTCL-NOS, a subtype of lymphoma.

CDKN2B deletions occur in over 10%. of several solid tumors, including bladder, glioma, lung (incl. squamous), head and neck, pancreatIC, esophageal, lung (incl.

Squamous), bladder, liver, hepatobiliary, breast), ovarian and others. In addition,CDKN2A deletions have be reported in 46% of patients With PTCL-NOS. CDKN2B deletings occur in over 10% of Several solid tumors, including bladder, Glioma, lung (in Cl.

squamous), head and Neck, pancreatic, esophagesal, sarcoma, ovarian and others. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor and the anti-mitotic program CYC140, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies.