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- New clinical, PK and PD data from novel CDK2/9 inhibitor fadraciclib monotherapy studies support ongoing development program in patients with solid tumors and lymphoma -
BERKELEY HEIGHTS, N.J., April 01, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC, NASDAQ:CYCCP, ", Cyclacel", or the ", Company", ))))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today 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:
| Title: | 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 |
| Abstract No. for Publication: | 3125 |
| Session Title: | Poster Session – Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology |
| Date and Time: | June 1, 2024, 9:00 AM - 12:00 PM CDT |
About Cyclin-Dependent Kinases and Fadraciclib
Cyclin-dependent kinases (CDKs) are critical for cell cycle control and transcriptional regulation. Dysregulated CDKs have been linked to the cancer hallmarks of uncontrolled proliferation and increased cancer cell survival. Fadraciclib is a highly selective, potent, orally and intravenously available, next generation inhibitor of CDK2 and CDK9. By inhibiting CDK2 and CDK9 fadraciclib causes apoptotic death through anaphase catastrophe of cancer cells at sub-micromolar concentrations.
To date single agent activity, including CR, PR and SD, has been observed in patients with advanced endometrial, squamous NSCLC lung cancer and T-cell lymphoma. Encouraging signals of activity were observed in patients with advanced cervical, hepatocellular, ovarian and pancreatic cancers.
065-101 Study of Oral Fadraciclib
Oral fadraciclib is being tested in a Phase 1/2 trial for the treatment of advanced solid tumors and lymphoma (065-101; NCT#04983810). A total of 47 patients have been treated as monotherapy in this ongoing study. The study is enrolling unselected, all comer 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, lung (incl. squamous), bladder, 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, melanoma, esophageal, sarcoma, hepatobiliary, breast, ovarian and others.
