Affimed has dosed the first participant in the first-in-human Phase I trial of AFM28 to treat CD123-positive relapsed/refractory (r/r) acute myeloid leukaemia (AML) patients.

The open label, multicentre, dose escalation Phase I AFM28-101 trial has been designed for evaluating pharmacodynamics, pharmacokinetics, tolerability, and safety of AFM28 monotherapy in the indicated patients.

The dose escalation’s aim is to establish the maximum tolerated dose (MTD) and/or one or more recommended Phase II doses (RP2D).

Affimed also plans to develop AFM28 along with allogeneic natural killer (NK) cell therapy.

The tetravalent bispecific CD123- and CD16A-binding innate cell engager (ICE) AFM28 has been developed on the Redirected Optimized Cell Killing (ROCK) platform of Affimed.

AFM28 works by engaging NK cells for commencing tumour cell killing through antibody-dependent cellular cytotoxicity (ADCC).

It has been designed to bring a new immunotherapeutic approach for CD123-positive myeloid malignancies patients, including myelodysplastic syndrome (MDS) and AML.

Affimed CEO Dr Adi Hoess said: “I’m proud of this milestone as AFM28 represents Affimed’s third wholly owned ICE molecule to enter the clinic.

“AFM28 has been designed to improve outcomes for AML patients in a differentiated manner from drugs currently used or in development for the treatment of AML.

“AFM28 broadens our footprint in haematological malignancies in addition to AFM13’s encouraging clinical activity as a single agent and in combination with NK cells and adds to our clinically validated pipeline with multiple expected data readouts in 2023.”

Last December, the French National Agency for the Safety of Medicines and Health Products (ANSM) authorised Affimed’s clinical trial application (CTA) for the Phase I study of AFM28 (AFM28-101) monotherapy for relapsed/refractory (r/r) AML.

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