AFM11 has the potential for high response rates and deep
responses, similar to blinatumomab. Given by bolus infusion it
is initially being developed in refractory aggressive NHL. 

  AFM11     ASH 2016 – AFM11  
  Affimed has published
a paper on its lead candidate AFM11 preclinical data >>>
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.


Medical Need in Non-Hodgkin Lymphoma

  Despite the progress made in the treatment of Non-Hodgkin Lymphoma, a high medical need remains for those patients that have relapsed from or become refractory to standard therapies. Time to relapse with increasing lines of therapy usually becomes shorter and shorter. Aggressive lymphoma such as Diffuse Large B-Cell Lymphoma (DLBCL) is still difficult to treat and represents the highest medical need in NHL in the relapsed / refractory setting. 

At least 80% of all lymphomas belong to the NHL group. Therefore, considering all B-cell lymphoma subtypes, the total annual incidence in North America, the EU and Japan is about 160,000 cases.
  AFM11 is an off-the-shelf product which does not require continuous infusion. Based on the expected pharmacokinetics, AFM11 can be individually dosed in order to optimize the safety for the patients. DLBCL alone represents about 46,000 new patients in North America, the European Union and Japan every year and currently some 20,000 patients annually relapse from or become refractory to a series of standard treatments and require new therapeutic options.  

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