Cyclacel Pharmaceuticals to Present New Clinical Data From Phase 2 Study of Oral Fadraciclib at the 2024 EORTC-NCI-AACR Symposium

Rhea-AI Summary

Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP) has announced that initial safety and efficacy data from its Phase 2 study of oral fadraciclib will be presented at the 2024 AACR-NCI-EORTC 36th Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain (October 23-25, 2024). The data comes from twelve patients with advanced solid tumors enrolled in Cohort 8 of the proof of concept study, who were preselected for CDKN2A and/or CDKN2B abnormalities.

The presentation, titled 'Fadraciclib, an oral CDK2/9 inhibitor, in patients with advanced solid tumors and lymphoma with CDKN2A and/or CDKN2B genetic alterations', will be displayed as a poster on October 23, 2024, from 12:00 p.m. to 7:00 p.m. CEST. This study is part of Cyclacel's efforts in developing innovative cancer medicines.

Positive

• Presentation of initial safety and efficacy data from Phase 2 study at a major cancer symposium
• Study focuses on biomarker-enriched patient cohort, potentially indicating targeted approach
• Fadraciclib being evaluated as a single agent, suggesting potential standalone efficacy

Negative

• patient sample size of only twelve patients
• Early-stage data, full efficacy and safety profile yet to be established

Initial safety and efficacy data from fadraciclib monotherapy in patients with advanced solid tumors preselected for CDKN2A and/or CDKN2B abnormalities

BERKELEY HEIGHTS, N.J., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative cancer medicines, today announced that initial safety and efficacy data from twelve patients with advanced solid tumors enrolled in the Phase 2 part of the 065-101 clinical study of fadraciclib as a single agent will be presented as a poster at the 2024 AACR-NCI-EORTC 36^th Symposium on Molecular Targets and Cancer Therapeutics (“Triple Meeting”), to be held in Barcelona, Spain (October 23-25, 2024). The patients were enrolled in the biomarker-enriched, Cohort 8 of the proof of concept study and were preselected for CDKN2A and/or CDKN2B abnormalities.

Details of the presentation are listed below:

Title:	Fadraciclib, an oral CDK2/9 inhibitor, in patients with advanced solid tumors and lymphoma with CDKN2A and/or CDKN2B genetic alterations
Abstract Number:	59
Session:	Molecular Targeted Agents
Date/Time:	12:00 p.m. – 7:00 p.m. CEST on Wednesday, October 23, 2024

About Cyclacel Pharmaceuticals, Inc.

Cyclacel is a clinical-stage, biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and the anti-mitotic program plogosertib, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. Cyclacel's strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications. For additional information, please visit www.cyclacel.com. 

Forward-looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include, among other things, statements related to Cyclacel’s future plans and prospects, Cyclacel’s anticipated cash runway and the planned timing of data results and continued development of fadraciclib. Factors that may cause actual results to differ materially include market and other conditions, the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates and Cyclacel’s ability to regain and maintain compliance with Nasdaq’s continued listing requirements. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact
Company:   Paul McBarron, (908) 517-7330, IR@cyclacel.com

© Copyright 2024 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel^® are trademarks of Cyclacel Pharmaceuticals, Inc.

FAQ

What is the purpose of Cyclacel's Phase 2 study of fadraciclib (CYCC)?

The Phase 2 study aims to evaluate the safety and efficacy of oral fadraciclib as a single agent in patients with advanced solid tumors, specifically those with CDKN2A and/or CDKN2B abnormalities.

When and where will Cyclacel (CYCC) present the fadraciclib study results?

Cyclacel will present the results as a poster at the 2024 AACR-NCI-EORTC 36th Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain, on October 23, 2024, from 12:00 p.m. to 7:00 p.m. CEST.

How many patients are included in the fadraciclib study data to be presented by Cyclacel (CYCC)?

The initial safety and efficacy data to be presented includes twelve patients with advanced solid tumors enrolled in Cohort 8 of the proof of concept study.

What is the mechanism of action of fadraciclib being developed by Cyclacel (CYCC)?

Fadraciclib is described as an oral CDK2/9 inhibitor, targeting cyclin-dependent kinases 2 and 9, which are involved in cell cycle regulation and transcription.