Heidelberg, Germany; February 08 2010: Affimed Therapeutics AG, the therapeutic TandAb antibody company, today announced the successful completion of the preclinical development of its lead product AFM 13 for the treatment of Hodgkin's lymphoma. Following promising preclinical data the company is now preparing the start of its first clinical study with AFM 13.
Preclinical pharmacology, pharmacokinetic and toxicology data have shown strong evidence for the tolerability and efficacy of AFM 13 to treat Hodgkin's lymphoma. Several studies with cynomolgus monkeys confirmed a good tolerability of the TandAb. No clinical toxicities were observed.
During the preclinical development of AFM 13 a robust GMP manufacturing process with a stable formulation was established. The generated clinical material is now ready for clinical development. Stability tests on the produced charges are ongoing.
AFM 13 is an innovative bispecific antibody based on the company's proprietary TandAb technology. TandAbs are tetravalent antibodies with manifold application possibilities. In the oncology indications TandAbs bind target molecules on the surface of tumor cells and simultaneously activate T cells or natural killer cells (NK cells). TandAbs are able to identify and selectively destroy tumor cells in the human body.
Dr. Rolf H. Günther, CEO of Affimed, commented: "This successful preclinical program adds a further important milestone to the development of our lead product and provides further validation of our technology platform. AFM 13 is the first TandAb antibody to enter clinical development from a pipeline of own preclinical TandAb candidates. The strong evidence of tolerability and efficacy in treating Hodgkin's lymphoma will be further verified through clinical trials. IND and IMPD filings will be submitted soon."
For further information please contact:
Affimed Therapeutics AG
Dr. Rolf H. Günther (CEO)
Phone: +49 6221 65307-0
Fax: +49 6221 65307 77
MC Services AG
Phone: +49 89 210 228 12
Fax: +49 89 210 228 88
About Affimed Therapeutics AG:
Affimed Therapeutics AG is a therapeutic antibody company developing unique antibody therapeutics as novel treatments for life threatening diseases with high unmet medical need. The company has been generating a growing pipeline of anticancer drug candidates based on its proprietary TandAb technology platform. Affimed's lead product candidate AFM 13 for the treatment of Hodgkin's disease has successfully completed preclinical development and will enter clinical studies in early 2010. Both AFM 11 and AFM 12 to treat Non-Hodgkin's lymphoma are currently in preclinical development and are expected to begin clinical studies in late 2010. Further novel product candidates are being developed for the treatment of solid tumors, autoimmune diseases and asthma. Affimed's proprietary and highly productive TandAb technology enables the company to generate unique tetravalent, bispecific, fully human antibody formats that promise increased therapeutic potential and superior profiles compared to monoclonal antibodies. The private company Affimed, which employs 26 people in Heidelberg, is a spin-off from the German Cancer Research Centre (DKFZ), Heidelberg.