ASH 2024 – Affimed plays up AFM28's safety, despite one death
Though Affimed claims that its anti-CD123 NK cell engager AFM28 is well tolerated up to 300mg, it has reported a patient death at a lower dose. At ASH on Monday the project yielded complete response rates of 17% and 40% among relapsed acute myelogenous leukaemia patients given 250mg (six subjects) and 300mg (10) respectively, but the data presentation revealed a dose-limiting toxicity at 200mg: one patient died of pneumonitis that was deemed "possibly related" to AFM28. Despite this the company played up AFM28's "good safety profile", and the presenting author, Dr Pau Montesinos of Hospital Universitari i Politècnic la Fe, said a 400mg cohort was planned, based on the dose-response relationship seen. No other pneumonitis events were observed, and only two cases of cytokine release were seen, though one, at 50mg, was grade 3. Targeting CD123 has been associated with toxicity and clinical holds, and discontinued projects with this mechanism include Xencor's vibecotamab, Novartis's JEZ567 and Cellectis's UCART123. Affimed shares closed up 3% on Monday.
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