CYCLACEL PHARMACEUTICALS, INC. (NASDAQ:CYCC) Files An 8-K Entry into a Material Definitive AgreementItem 1.01:
On October 1, 2018, Cyclacel Pharmaceuticals, Inc. (the “Company”) entered into a Clinical Collaboration Agreement (the “CCA”) with The University of Texas MD Anderson Cancer Center (“MD Anderson”). The main objective of the CCA is to clinically evaluate the safety and efficacy of three Cyclacel medicines in patients with hematological malignancies, including chronic lymphocytic leukemias (“CLL”), acute myeloid leukemias, myelodysplastic syndromes (“MDS”) and other advanced leukemias. Under the terms of the CCA, MD Anderson will conduct four clinical studies with a total projected enrollment of up to 170 patients. The four protocols will study CYC065, CYC140 and sapacitabine either as single agents or in combination with approved drugs.
It is anticipated that the first study to be initiated under the CCA will be a Phase 1b trial evaluating a combination of CYC065, a cyclin dependent kinase inhibitor, and venetoclax, an approved drug targeting the Bcl-2 protein, in patients with relapsed or refractory CLL. The second study is expected to be a Phase 1, first-in-human evaluation of CYC140, a Polo-like kinase 1 inhibitor, in patients with advanced leukemias or MDS. Both of these studies have received institutional review board (IRB) approval, and two further protocols evaluating combinations of CYC065 and sapacitabine with approved agents are currently in development.
The Company shall be the regulatory sponsor of all studies governed by the CCA and is responsible for making the necessary filings with the Food and Drug Administration, and MD Anderson’s principal investigators will lead such studies. Additionally, MD Anderson will assume the patient costs for all studies and Cyclacel will provide investigational drugs and other limited support. Upon first commercial sale in specific indications studied under the CCA, Cyclacel will make certain payments to MD Anderson.
The CCA shall remain in effect for the duration of the three-year period during which payments are due to MD Anderson. Additionally, each of the Company and MD Anderson may terminate the CCA if the other party commits a material breach of its obligations thereunder and fails to cure such breach within ninety (90) days of receiving notice from the non-breaching party.
The foregoing summary of the CAA does not purport to be complete and is qualified in its entirety by reference to the CAA, which will be filed as an exhibit to the Company’s quarterly report on Form 10-Q for the quarter ending September 30, 2018, with portions omitted and filed separately with the Securities and Exchange Commission to a request for confidential treatment.
On October 4, 2018, the Company issued a press release announcing that the Company had entered into the CCA described in Item 1.01 above. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01: | Financial Statements and Exhibits. |
| Exhibit Number | Description |
| 99.1 | Press Release dated October 4, 2018 |
Cyclacel Pharmaceuticals, Inc. ExhibitEX-99.1 2 tv504171_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Cyclacel Pharmaceuticals,…To view the full exhibit click here
About CYCLACEL PHARMACEUTICALS, INC. (NASDAQ:CYCC)
Cyclacel Pharmaceuticals, Inc. operates in the field of cell cycle biology. The Company has generated various families of anticancer drugs that act on the cell cycle, including nucleoside analogs, cyclin dependent kinase (CDK) inhibitors, polo-like kinase (PLK) inhibitors and Aurora Kinase/vascular endothelial growth factor receptor (AK/VEGFR) inhibitors. Its family of anticancer drugs that act on the cell cycle include sapacitabine, seliciclib and CYC065. Its lead candidate, sapacitabine, is an orally available nucleoside analog. A number of nucleoside drugs, such as gemcitabine and cytarabine, also known as Ara-C, both generic drugs, are in use as conventional chemotherapies. Seliciclib, its lead CDK inhibitor, is an oral inhibitor of CDK2/9 enzymes that are central to the process of cell division and cell cycle control. Its second-generation CDK inhibitor, CYC065, is an inhibitor of CDKs targeting CDK2/9 enzymes with utility in both hematological malignancies and solid tumors.
