Micromet, a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer, has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to expand development of the company’s lead product candidate blinatumomab in patients with acute lymphoblastic leukaemia (ALL) and various sub-types of lymphoma. Blinatumomab is the first of a new class of agents called BiTE antibodies, designed to harness the body's T cells to kill cancer cells.
Under the terms of the agreement, the NCI and Micromet will collaborate on a series of clinical trials to evaluate the safety and efficacy of blinatumomab in patients with B-cell derived haematologic malignancies. The initial NCI-sponsored studies will explore blinatumomab’s utility as a first-line treatment for patients newly diagnosed with ALL, older patients with ALL, and patients with Waldenstrom’s macroglobulinemia. Additional studies will be designed based on the agreement of both parties.
“We are very pleased that the NCI has chosen to support the clinical development of blinatumomab,” said Jan Fagerberg, MD, PhD, Micromet’s senior vice president and chief medical officer. “This partnership will enable us to further explore blinatumomab’s clinical potential across a wide range of blood cancers and will expand leading US investigators’ experience with the drug.”
Blinatumomab (MT103) is a next-generation monoclonal antibody-based therapeutic designed to direct the body's cell destroying T-cells against target cells expressing CD19, a protein expressed on the surface of B-cell derived ALL and non-Hodgkin's lymphomas. Micromet has received orphan drug designation from the European Medicines Agency for blinatumomab for the treatment of ALL, mantle cell lymphoma and chronic lymphatic leukaemia and from the US Food and Drug Administration for the treatment of acute lymphoblastic leukaemia, chronic lymphocytic leukaemia and indolent B cell lymphoma.