|AFM11 is a T-cell TandAb recognizing CD19 and utilizing its second functionality, binds with high affinity to T-cells and activates them. CD19 is expressed on multiple B-cell malignancies, including various forms of Non-Hodgkin Lymphoma (NHL) and Acute Lymphocytic Leukemia (ALL). In North America, the EU and Japan, more than 160,000 NHL patients and 14,000 ALL patients are diagnosed annually with these diseases.
AFM11 is in phase 1 clinical development in patients with relapsed / refractory B-cell NHL. Affimed is conducting a phase 1 dose escalation study with a primary focus on safety, as well as pharmacokinetics and anti-tumor activity. AFM11 is given by bolus infusion.
Although there is significant competition in NHL, a high need remains in refractory Diffuse Large B-Cell Lymphoma (DLBCL). Until now most new therapeutic options have shown modest response rates in these patients. However, by far the strongest effects were seen with treatments using T-cells to fight the cancer.
The response rates observed with this product are about twice as high
|as those obtained with other experimental treatments used currently in the salvage setting, and the complete responses are all molecular responses, i.e. CD19-positive cells are completely ablated such that none are detectable with the most sensitive techniques available. Studies suggest that the absence of minimal residual disease is a predictor of long-term outcome, and hence this observation may translate into extended progression-free survival.
In preclinical studies, AFM11 has shown very potent cytotoxicity, even at very low T-cell counts. This differentiation to blinatumomab may be of clinical relevance for patients whose immune system is compromised e.g. from myelosuppressive chemotherapies, or for patients with tumors where perfusion is restricted. Furthermore, AFM11 is administered by regular IV-infusion and continuous infusion is not required, another differentiation from blinatumomab, which currently is administered by continuous infusion. In addition, Affimed has recently initiated a phase 1 clinical trial in ALL.