Cyclacel Reaches Major Milestone in Fadraciclib Study for Advanced Cancer Patients

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative cancer therapies, announced the completion of patient enrollment for Cohort 8 in its ongoing Phase 2 trial of fadraciclib, a CDK2/9 inhibitor. This cohort is composed of 12 patients with advanced solid tumors and lymphomas showing CDKN2A/B abnormalities. The trial aims to test the safety and efficacy of fadraciclib, which has shown promising results in controlling tumor growth and improving patient outcomes.

The company also continues enrolling patients in Cohort 5, which focuses on individuals with T-cell lymphoma. The Phase 2 study, known as 065-101, is structured around eight distinct cohorts, each defined by specific tumor histologies or molecular markers. Cohort 8 is the first to focus on patients whose tumors have CDKN2A/B abnormalities, which are prevalent in cancers such as glioma, pancreatic, lung, and bladder cancer.

Cyclacel's CEO, Spiro Rombotis, celebrated the progress, stating, "This milestone reflects the urgent need for new therapies for cancer patients with CDKN2A/B abnormalities." He also highlighted that the rapid enrollment of patients—completed in roughly six months—underscores the potential impact of fadraciclib. Cyclacel is set to present updated safety and efficacy results at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in October 2024.

The trial has already shown promise in earlier phases. Dr. Brian Schwartz, interim Chief Medical Officer, noted stable disease and even tumor shrinkage in patients with squamous cell carcinoma, both in this trial and previous Phase 1 studies. For example, a patient with non-small cell lung cancer (NSCLC) achieved a 22% reduction in tumor size after four weeks of treatment, based on RECIST 1.1 criteria.

The fadraciclib trial employs a Simon two-stage design and focuses on various cancer types, including endometrial, ovarian, cholangiocarcinoma, breast, and colorectal cancers, among others. Early indications show that fadraciclib may outperform inhibitors that target either CDK2 or CDK9 alone, offering a new potential avenue for patients who lack effective treatments.

In its Phase 1 trial, fadraciclib was tested on 48 patients with a range of advanced cancers. The recommended Phase 2 dosage was established at 100 mg twice daily for five days each week. In addition to positive outcomes like complete response (CR) and partial response (PR), the drug has shown a good safety profile, with no serious hematological toxicity observed during the first cycle.

CDKN2A/B abnormalities, found in over 40% of some solid tumors, including glioma, pancreatic, and lung cancers, represent a critical target for Cyclacel's drug development strategy. The company's broader mission is to build a portfolio of therapies aimed at difficult-to-treat cancers through its expertise in cell cycle regulation and transcriptional control.

As Cyclacel continues to make progress with its innovative cancer therapies, the biopharma company remains committed to addressing unmet needs for patients battling aggressive forms of cancer.