Citaat uit het Nature artikel:
The protocol employed by MD Anderson, however, requires freshly prepared NK cells, which limits the therapy’s utility. To overcome this constraint, Affimed has teamed up with Artiva Biotherapeutics, which can produce industrial quantities of NK cells. From a single unit of cord blood, it can generate about 80,000 doses, each containing 1 billion cryopreserved NK cells. A screening step preselects NK cells with two genetic features that improve their downstream performance: they encode a high-affinity variant of the CD16 receptor and possess a KIR-B haplotype, the more active of the two general NK cell genotypes. After two expansion and activation steps, the resulting NK cells then undergo a quality control process to maintain batch-to-batch consistency.
Artiva’s AB-101, an unmodified allogeneic NK cell therapy, is already undergoing a phase 1/2 trial, in combination with the CD20 inhibitor rituximab, in patients with B cell NHL, but the combination with AFM13 will require a separate investigational new drug approval from the US Food and Drug Administration before it can be tested in patients. That trial will be designed to enable registration, should the partners detect a similar efficacy signal to that obtained on the MD Anderson study.
Opmerkingen:
- AB101 voorziet in een KIR-B haplo type NK cel. Dit is m.i. onderscheidend tov de MD Anderson cellen. Deze cellen zijn bewezen effectiever bij leukemie.
- zijn de MD Anderson cellen geselecteerd op het aanwezig zijn van CD16?
AB101 lijkt zeker op papier superieur aan de MD Anderson cellen.
In het zelfde stuk wordt een geleerde uit San Francisco geciteerd: "no NK cell has ever killed a patient." Dit zal de FDA ook weten. Gaan met die banaan zou ik zeggen.