The Leukemia & Lymphoma Society and Affimed Therapeutics Partner To Advance AFM13 in a Phase 2 Trial for Refractory and/or Relapsed Hodgkin Lymphoma Patients

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Sep 16, 2013, 09:00 ET

WHITE PLAINS, N.Y. and HEIDELBERG, Germany, Sept. 16, 2013 /PRNewswire/ -- The Leukemia & Lymphoma Society (LLS) and Affimed Therapeutics AG today 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 . AFM13 is a first-in-class immunotherapy drug designed to treat HL patients and patients with CD30 positive malignancies. LLS has committed to investing up to $4.4 million over 2 years to support the project.

Richard Winneker, Ph.D., senior vice president of research for LLS stated, "Though the cure rate for Hodgkin lymphoma is high compared to other types of blood cancers, refractory and relapsed patients have few therapeutic options. More importantly, current treatments for HL patients involve cytotoxic drug therapies and radiotherapy, which are likely responsible for secondary tumors and other considerable long term side effects developing later in a patient's life, leaving open a critical need for safer and more durable therapies. LLS is committed to advancing breakthrough therapies, particularly for patients with unmet medical needs, and Affimed's immunotherapy is emerging as a promising therapeutic option for HL patients."

"The partnership between Affimed and LLS is a significant validation of the high potential of our TandAb platform and reinforces our strategy to develop this novel bispecific construct for hematological tumors," said Dr. Adi Hoess, CEO of Affimed AG. "We very much welcome LLS's commitment to AFM13, and we look forward to an accelerated development of this therapy for patients with limited treatment options to date."

In a phase 1 trial, AFM13 has shown a good safety profile, as it was well tolerated at all dose levels tested. Furthermore, 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.

About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society ® (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.

Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org. Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 6 p.m. ET.

About TandAbs and AFM13
TandAbs®, which were invented and developed by Affimed scientists, 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. TandAbs® possess the same avidity and affinity for each target as an IgG. Combined with their bispecificity, this format represents a potent further development of therapeutic monoclonal antibodies and, potentially, a superior alternative to first generation antibody formats/scaffolds.

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. A robust production process for AFM13 has been established with excellent stability of the drug substance and drug product.

About Hodgkin Lymphoma
Hodgkin lymphoma (HL) is a malignant type of cancer targeting the lymphatic system, with the highest incidence among those aged between 20-40 years, and over 70 years. HL has a yearly incidence of about 9,000 new patients in the US. Despite the strong potential for recovery at the early stage of the disease, therapeutic approaches have so far been insufficient with regard to those patients who do not respond to aggressive chemo- and radiotherapy. Due to the severe side-effects and the toxicity of this combined chemo- and radiotherapy, there is a great need for new and less toxic medical treatments.

About Affimed Therapeutics AG
Affimed Therapeutics AG is developing unique bispecific antibody therapeutics as novel treatments for life threatening diseases with high unmet medical needs. The company has generated a growing pipeline of drug candidates based on its proprietary TandAb® antibody platform. Affimed's product candidates are developed for the treatment of CD19-positive (AFM11) and CD30-positive tumors (AFM13). Further novel product candidates are in development to treat solid tumors and autoimmune diseases. Affimed's 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. Affimed, through its subsidiary Amphivena, recently entered in a collaboration with Janssen Biotech to develop a bispecific TandAbs® for the therapy of an undisclosed hematologic tumor. The private company Affimed, which employs 33 people in Heidelberg, is a spin-off from the German Cancer Research Centre (DKFZ), Heidelberg.

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