The University of Texas MD Anderson Cancer Center and Cyclacel Pharmaceuticals, Inc., today announced a three-year strategic alliance agreement that will enable clinical evaluation for safety and efficacy of three Cyclacel medicines in patients with hematological malignancies, including chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and other advanced leukemias.
MD Anderson will conduct four clinical studies with a total projected enrollment of up to 170 patients, which will investigate CYC065, CYC140 and sapacitabine either as single agents or in combination with approved drugs. The collaboration leverages MD Anderson's expertise in clinical development of drugs for hematological malignancies and Cyclacel's novel drug portfolio that is based on the Company's knowledge of cell cycle biology and mechanisms of cancer cell resistance to medicines. "MD Anderson is committed to identifying and evaluating innovative therapies to benefit patients with life- threatening hematological malignancies," said Hagop Kantarjian M.D., chair in the Department of Leukemia at MD Anderson. "This alliance will allow us to study three compounds in development that appear to have promising preclinical and clinical data supporting their further evaluation." "We are excited to expand our partnership with this alliance and advance the clinical development of CYC065 (our lead program), CYC140 and sapacitabine," said Spiro Rombotis, president and chief executive of Cyclacel. "MD Anderson is forging novel collaborative models to accelerate development of promising therapies. The alliance will enable us to parallel track the development of multiple Cyclacel drugs over the next three years with the ultimate goal of benefiting patients with unmet medical needs."
Under the risk-sharing agreement MD Anderson will assume the patient costs for all studies and Cyclacel, who is the sponsor, will provide investigational drugs and other limited support. Upon first commercial sale in specific indications studied in the alliance, Cyclacel will make certain payments to MD Anderson.
The first study will be a Phase 1b trial evaluating a combination of CYC065, a cyclin-dependent kinase (CDK2/9) inhibitor with venetoclax, an approved drug targeting the Bcl-2 protein, in patients with relapsed or refractory CLL. The second study will be a Phase 1, first-in-human evaluation of CYC140, a Polo-like kinase 1 (PLK1) inhibitor, in patients with advanced leukemias or MDS. Both studies have received institutional review board (IRB) approval. Two further protocols evaluating combinations of CYC065 and sapacitabine either as single agents or in combination with approved agents are in development.