Press Release - April 10, 2014
Heidelberg, Germany, April 10, 2014 – Affimed Therapeutics AG announced today further results from its phase 1 clinical trial of AFM13 as monotherapy for the treatment of patients with advanced relapsing/refractory (R/R) Hodgkin lymphoma. AFM13 is a bispecific TandAb antibody recruiting host natural killer (NK) cells via its CD16A-binding domains to engage and kill CD30-positive malignant cells.
In the clinical phase 1 study, 28 heavily pretreated patients suffering from R/R Hodgkin lymphoma received infusions of AFM13 with increasing doses in the range of 0.01 mg/kg up to 7 mg/kg. AFM13 was administered once weekly over 4 weeks in the majority of the patients. Primary endpoints were safety and tolerability. Secondary endpoints were pharmacokinetics, pharmacodynamics and clinical efficacy. The data were presented by Max Topp, Professor of Medicine at the University of Wuerzburg, at the AACR Annual Meeting 2014, San Diego, CA, USA, on April 8, 2014. The presentation is being made available by AACR via Webcast.
“The clinical phase 1 trial met its primary endpoint and demonstrated that AFM13 can be administered safely. Clear activity could be demonstrated with the potential to further maximize the effect by optimizing the dose regimen and extending the treatment duration,” said Jens-Peter Marschner, MD, Chief Medical Officer of Affimed. “These data are promising, in particular because there is no alternative treatment option for patients in this setting. A phase 2 study investigating an optimized dose regimen will be initiated this year.”
Affimed Therapeutics AG
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Affimed Therapeutics AG develops cancer therapies that direct the immune system to eliminate tumor cells. Its next generation multifunctional antibodies (TandAbs®, FlexiBodies®) engage two of the most potent cytotoxic cells of the immune defense arsenal (T-cells or natural killer (NK) cells) and link them with high affinity and precision to a tumor cell, thus triggering an attack by the immune cell that ultimately results in the destruction of the tumor cell. The company is positioned in the promising and dynamic field of cancer immunotherapy with two fully owned TandAb products in clinical development. AFM13 targets CD30-positive malignancies, such as Hodgkin Lymphoma (HL). This program is co-funded by the Leukemia and Lymphoma Society (LLS). In a phase 1 study, AFM13 has demonstrated a promising profile in relapsing/refractory refractory HL patients and is expected to advance into phase 2 studies late 2014. AFM11 targets CD19-positive malignancies, such as Non-Hodgkin Lymphoma (NHL). A phase 1 study with AFM11 in refractory NHL patients is expected to start in the second quarter of 2014. In addition, the company has in preclinical development a program targeting solid tumors through the selective tumor target Epidermal Growth Factor Receptor, Variant III (EGFRvIII). For more information, please visit www.affimed.com.
Affimed develops TandAbs and FlexiBodies, both targeted immunotherapies, with the aim to provide new treatment options to patients. These therapies are characterized by strong efficacy and high specificity, combined with a favorable safety profile. The company has three proprietary platforms based on antibody variable domains: