How AFM11 works
AFM11 is a so-called tandem antibody (TandAb) as it can bind to two targets at the same time: CD-19 on B-cells and CD3 on T-cells. CD-19 is a protein expressed by cancerous B-cells in many different types of blood cancers, including non-Hodgkin’s lymphoma (NHL) and acute lymphocytic leukemia (ALL). By binding to CD-19 AFM11 destroys B-cells directly; when it binds to CD3 it activates T-cells to destroy CD-19–positive B-cells.
It has a high affinity for its targets, meaning it creates strong attachments to CD-19 and CD-3. Because it is attracted so strongly to these targets, it is effective even in patients with low T-cell counts due to previous chemotherapy treatments.
AFM11 in clinical trials
Affimed presented data from preclinical studies in December 2015 that supported AFM11’s ability to bind to its targets and activate T-cells. A helpful diagram that shows the tandem binding of AFM11 with its targets appeared in a poster presentation of results from preclinical studies.
It is now being tested in two Phase 1 clinical studies.
The first is a multi-center clinical trial (NCT02106091), which began in April 2014, evaluating the safety of AFM11 in about 50 people with relapsed or refractory CD-19 positive B-cell NHL. Patients enrolled have all undergone other treatments that either did not bring their cancer into remission (refractory disease), or did not prevent it from returning (relapsed disease). Participants will be monitored for adverse events as they receive increasing doses of AFM11 over the course of four weeks. The study is expected to finish in December 2017 and is still recruiting participants.
A second clinical trial (NCT02848911) involves patients with relapsed or refractory adult B-cell ALL and began in October 2016. Patients are being monitored for adverse events as they receive increasing doses of AFM11 with different infusion times. The study will analyze the way the drug moves in the body (pharmacokinetics), and assess its effectiveness by observing changes in the patients’ bone marrow where blood cells are produced.
AFM11 does not require continuous infusion because it is given via a bolus intravenous infusion, meaning that each dose can be given as an injection into a standard vein. According to results of pharmacokinetic studies, AFM11 can be individually dosed for optimum safety in any given patient.
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