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.
Key Data from AFM13
- AFM13 binds selectively to NK cells through CD16A (FcγRIIIA); neutrophils carrying CD16B (FcγRIIIB) are not bound
- Cytotoxic potency of AFM13 is consistently higher than those of the Fc-enhanced and native anti-CD30 IgGs
- Each of the intravenously administered doses of AFM13 was considered safe and well tolerated, a maximum tolerated dose was not reached
- AFM13 treatment resulted in a significant increase of activated NK cells in peripheral blood, which was more pronounced at dose levels>
- Soluble CD30 values decreased during treatment with AFM13; this effect was pronounced in patients receiving dose levels>
- Pharmacokinetic data revealed a dose proportional increase of systemic exposure with a half-life of 10-22 hours
- Clinical activity was observed over all dose levels and included patients that received prior brentuximab vedotin. Clinical activity was more pronounced at higher dose levels, and all partial responses (PRs) were observed at doses>
"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."
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