Cyclacel Announces Notice of Intention to Grant New European Patent Covering Plogosertib Pharmaceutical Compositions
In This Article:
Lengthens Patent Exclusivity of Plogosertib until August 2040
BERKELEY HEIGHTS, N.J., June 26, 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 the receipt of a notice from the European Patent Office of the intention to grant a patent which includes claims to novel pharmaceutical compositions of plogosertib, a PLK1 inhibitor. Once granted, the European patent will provide exclusivity until August 2040 not including any extensions. The Company is prosecuting patent applications from the same family in other jurisdictions.
"The notice further strengthens the Company’s patent portfolio and attests to the novelty of Cyclacel’s clinical pipeline, which includes plogosertib and fadraciclib, both of which were discovered in house," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "The patent supports our switch to a new oral formulation of plogosertib with improved bioavailability. Our strategy is to test in the clinic whether certain ARID1A- and/or SMARCA-mutated cancers may benefit from treatment with plogosertib. We are also following a precision medicine approach with our lead drug candidate, fadraciclib, a CDK2/9 inhibitor, which is being evaluated in a proof of concept study initially in patients with solid tumors prospectively selected for CDKN2A/CDKN2B alterations, followed by patients with T-cell lymphoma, with initial proof of concept data expected in the second half of 2024.”
About Polo-like Kinase and Plogosertib
Polo-like kinase 1 (PLK1) is a serine/threonine kinase that plays a central role in cell division or mitosis. PLK1 is an important regulator of the DNA damage cell cycle checkpoint, mitotic entry and exit, spindle formation and cytokinesis, or cell separation into daughter cells. Cancer cells in general, and in particular KRAS mutated and p53(-) cells, are very sensitive to PLK1 depletion. In contrast normal cells with intact cell cycle checkpoints are less sensitive. Pharmacological inhibition of PLK1 in cancer cells blocks proliferation by prolonged mitotic arrest and induces onset of apoptotic death of such cells.
Plogosertib (formerly CYC140) is a novel, small molecule, selective and potent PLK1 inhibitor. It has demonstrated impressive efficacy in human tumor xenografts at nontoxic doses. Cyclacel’s translational biology program supports the development of plogosertib in solid tumors and leukemias. Preclinical data from independent groups have shown that certain ARID1A- and/or SMARCA-mutated cancers may benefit from treatment with plogosertib. Additionally, recent data suggest that PLK1 inhibition may be effective in KRAS-mutated metastatic colorectal cancer. PLK1 overexpression correlates with poor patient prognosis in several tumors, including esophageal, gastric, leukemia, lung, ovarian, and squamous cell cancers, as well as MYC-amplified cancers.