Date: 2013-09-16
Type of information: Clinical research agreement
Compound: AFM13
Company: Affimed Therapeutics (Germany) The Leukemia & Lymphoma Society (USA)
Therapeutic area: Cancer - Oncology
Type agreement: collaboration
clinical research
Action mechanism: AFM13 is a bispecific TandAb®antibody recruiting host NK cells via its CD16A-binding domains to engage and kill CD30-positive malignant cells. TandAbs®, which were invented and developed by Affimed, are tetravalent bispecific antibody formats that have two binding sites for each antigen. They bind to target molecules on the surface of tumor cells and specifically activate immune effector cells such as cytotoxic T-cells or natural killer (NK) cells in the presence of tumor cells. The TandAb® AFM13 is specifically designed to treat CD30-positive malignancies. It targets CD30 on malignant cells and CD16A on NK-cells. The simultaneous binding to both cells leads to an effective lysis of the tumor cells. In cytotoxicity assays, AFM13 has been shown to possess higher potency than antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced CD30 IgGs.
Disease: Hodgkin lymphoma
Details: * On September 16, 2013, Affimed Therapeutics AG and The Leukemia & Lymphoma Society have announced a partnership to co-fund a phase 2 trial with the Recruit-TandAb AFM13, a novel tetravalent bispecific antibody directed against human CD30 and CD16A in Hodgkin Lymphoma (HL) patients for whom currently available treatments have failed. LLS has committed to investing up to $4.4 million over 2 years to support the project.
In a phase 1 trial, AFM13 has shown a good safety profile, as it was well tolerated at all dose levels tested. AFM13 showed clear and meaningful signs of efficacy in some patients deemed to have a poor prognosis, including patients who had not benefited from the recently approved CD30 targeting drug, brentuximab vedotin (Adcetris®, Seattle Genetics). These encouraging data warrant the further investigation of AFM13 in a phase 2 trial to further assess its efficacy. Moreover, these trials could provide proof of concept for using bispecific antibodies to elicit natural killer (NK) cells, vital lymphocytes of the innate immune system, to effectively kill cancer cells.
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