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

The open label, first-in-human dose escalation, multicentre Phase I AFM28-101 study has been designed for evaluating the pharmacodynamics (PD), tolerability, pharmacokinetic (PK), and safety of AFM28 IV monotherapy in CD123-positive r/r AML patients.

The dose escalation is aimed at establishing the maximum tolerated dose and/or one or more recommended Phase II doses.

This will help in guiding the clinical development of AFM28 alone and/or in combination with other therapeutics, such as allogeneic natural killer (NK) cell therapy.

Developed on the company’s Redirected Optimized Cell Killing (ROCK) platform, AFM28 is a tetravalent bispecific CD123- and CD16A-binding Innate Cell Engager (ICE).

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

The clinical development of AFM28 is planned to commence in the first half of next year.

Affimed chief operating officer Dr Wolfgang Fischer said: “The CTA approval in France is an important milestone in our strategy to develop AFM28 as quickly as possible.

“AML is one of the worst blood cancers with poor patient prognosis, especially in the relapsed or refractory setting, with no standard-of-care salvage regimen currently available.

“Given the aggressive nature of the disease, and the desperate need for viable treatment options, it is a high priority for Affimed to advance the clinical development of AFM28 for relapsed/refractory AML patients.”

The company stated that the CTAs for AFM28-101 in other European jurisdictions are currently ongoing, with other applications planned to be submitted early next year.