German biotech Affimed caught some attention earlier this year with a pair of complete responses in an early study of its NK cell regimen for lymphoma. The biotech is back with more data from that study, and the results look promising — but will durability hold up?
A combination regimen of donor NK cells and Affimed’s CD30-targeting innate cell engager AFM13 spurred responses in 16 of 18 patients with relapsed or refractory Hodgkin and non-Hodgkin lymphomas, including seven complete responses, as part of the first of two rounds of treatment in a Phase I/II study, the biotech said Monday.
In a cohort of patients treated with the highest dose of the combination therapy in the first of two treatment rounds, all 12 posted an objective response, including five complete responses and seven partials, Affimed said. All of those patients will be continued on a second round of treatment, which includes lymphodepleting chemotherapy followed by a single infusion of cord blood-derived NK cells ‘pre-complexed’ with AFM13 and then three weekly infusions of AFM13 solo.
Affimed also touted early safety data for the therapy with five cases of transient infusion-related reactions after the monotherapy infusions of AFM13 and no serious side effects reported.
This MD Anderson-sponsored study turned a few heads back in April when Affimed churned out early data showing significant disease reduction in all four lymphoma patients evaluable at the time, including two complete responses. The patients in this study were heavily pretreated with a median of six prior lines of therapy, and Affimed’s thinking is that AFM13 adds a boost to patients’ innate immune systems that allows NK cells to be more effective in attacking cancer. That could potentially crack wide open the use of therapy in later-line patients, the hardest to treat.
NK cells themselves offer a tantalizing alternative to T cells, which have shown high efficacy in attacking tumors but also come with well-known deleterious side effects. On the flip side, NK cells have struggled to show long-lasting durability in early trials, potentially requiring repeated dosing over time.
In Affimed’s case, all eyes will be on the second course of therapy that these early patients face and whether the combo regimen can continue to hold up over time. Investors appeared to be wary of drawing too many conclusions heading into that phase, with shares of the biotech trading down about 3% at the opening bell.
Outside of the AFM13 data, it’s been a quiet year for Affimed after it signed a deal with Roivant back in November 2020 worth $60 million in cash and downstream biobucks for a licensing pact centered on bispecific antibodies. The German firm had previously signed a similar deal with Genentech back in 2018 for $96 million upfront and a whopping $5 billion in milestones.
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