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Clinical Trials

Date: 2015-05-29

Type of information: Presentation of results at a congress

phase: preclinical

Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago

Company: Affimed (Germany)

Product: AMV-564 (formerly T564)

Action mechanism:

monoclonal antibody/bispecific antibody

Disease: acute myeloid leukemia (AML)

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

* On May 29, 2015, Affimed, a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies based on its proprietary TandAb platform, announced that first data on AMV-564 (formerly T564), the product candidate currently in INDenabling studies, from the Company’s Amphivena/Janssen collaboration will be presented on Saturday, May 30, and Sunday, May 31 at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting being held May 29 – June 2, 2015 in Chicago, IL.
Data from three posters by Affimed and its partners Amphivena and Janssen on its collaborative CD33/CD3 program for the treatment of acute myeloid leukemia (AML) validates the robustness of Affimed’s proprietary TandAb technology platform. Overall, using various combinations of 10 human anti-CD33 variable domains, 4 human anti-CD3 variable domains and different middle linkers, the platform has enabled generating more than 150 unique CD33/CD3 TandAbs for further evaluation.
• In Abstract #7071, titled “Development of a bispecific tetravalent CD33/CD3 TandAb for the treatment of AML” (by Amphivena and Affimed, on Sunday, May 31), 22 lead TandAbs were selected based on expression titers, homodimer content, melting temperature, thermal stability, and high-affinity CD33 binding or to preserve diversity of CD33 domain or linker, and subsequently were produced and purified to >90% purity. Notably, bivalent high affinity binding did not elicit significant cytokine release in the absence of CD33+ cells.
• Abstract #7067, titled “Construction characterization of novel CD33/CD3 tandem diabodies (TandAbs) for the treatment of acute myeloid leukemia (AML)” (by Dr. Roland Walter of the Fred Hutchinson Cancer Research Center, on Sunday, May 31), demonstrated that CD33/CD3-targeted TandAbs exerted potent and specific cytotoxicity in CD33+ leukemia cells that is independent of disease stage and cytogenetic risk. Moreover, CD33 and CD3 binding affinities correlated with T-cell  activation and cytotoxicity, but no correlation between TandAb-induced specific cytotoxicity and CD33 expression level was observed.
• Abstract #3057, titled “In vitro and in vivo killing of AML using tetravalent bispecific CD33/CD3 TandAbs” (by Dr. John DiPersio of Washington University in St. Louis, on Saturday, May 30), showed that TandAbs specifically lysed human CD33+ target cell lines, but not human cells lacking the antigen, at concentrations as low as 0.001 and 1pM. Also, preclinical mouse data revealed that even though very few patient T cells (2%-4%) may be present, TandAbs could still clear all AML blasts.

Is general: Yes