Affirmed's bispecific AFM13 plus allogeneic NK cells resultsApril 10, 2022 - Affimed has unveiled a bigger dataset of 19 lymphoma patients in a phase 1 trial, confirming AFM13 has put 17 of them into remission and presented at this year’s AACR . Among high-dose patients the number of complete responses has increased from five to eight after the second cycle, and the CR rate across all doses is 53%. With the caveat of relatively short follow-up (median 11 months) 53% of patients are progression-free, and 79% are still alive. Importantly, there was only one serious adverse event, a grade 3 infusion-related reaction, and no cytokine release, neurotoxicity or graft versus host.
AFM13 is a bispecific MAb targeting CD30 and CD16A, thus acting as a bridge not with T but with NK cells.
The MD Anderson trial is different in that it also includes allogeneic cord blood-derived NK cells, which are activated, expanded and combined with AFM13 before being infused into the patient.
It might be that such a complex manufacturing procedure is unviable commercially, and the big question is whether AFM13 on its own can be efficacious.
Affimed used to develop T cell-recruiting bispecifics, but as this became a hugely competitive area it pivoted to NK-cell engagers like AFM13.
https://www.evaluate.com/vantage/articles/events/conferences-trial-results/aacr-2022-affimed-shows-2021-was-no-fluke