Biotechnology company Affimed N.V. has announced the successful dosing of the first patient in a phase 1 clinical trial of innate cell engager (ICE®) AFM28 monotherapy. The study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AFM28 in patients with CD123-positive relapsed or refractory acute myeloid leukemia (AML).
AFM28 is designed to direct natural killer (NK) cells to CD123-positive leukemic cells, including blasts and leukemic stem and progenitor cells, in order to induce depletion. The ICE molecule is a tetravalent bispecific CD123- and CD16A-binding protein developed on Affimed’s Redirected Optimized Cell Killing platform. This makes it possible for AFM28 to boost patients’ immune systems and enable them to fight cancer by tapping into the untapped potential of the innate immune system.
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Dr. Adi Hoess, Affimed’s CEO, said he was proud of the milestone and that AFM28 represents its third wholly-owned ICE molecule to enter the clinic. “AFM28 broadens our footprint in hematological 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,” he added. This news has come as a ray of hope for patients with AML, a highly aggressive form of blood cancer, who have limited treatment options.
The clinical trial, designated AFM28-101, aims to establish the maximum tolerated dose (MTD) and/or one or more recommended phase 2 doses (RP2D) of AFM28 for the treatment of CD123-positive r/r AML. With the trial’s principal investigator, Pau Montesinos, leading the study, AFM28 will be tested with both monotherapy and in combination with allogeneic NK cell therapy.
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Further, Affimed has confirmed its plans to continue developing AFM28 in combination with allogeneic NK cell therapy. The broad potential of ICE molecules, beyond hematological malignancies and solid tumors, makes them a promising new and innovative therapy at a time when demand for such treatments remains high.
Affimed, located in Heidelberg, Germany, is a clinical-stage immuno-oncology company committed to developing a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The company’s ROCK platform enables a tumor-targeted approach to recognize and kill various hematologic and solid tumors, using customized innate cell engager molecules to destroy cancerous cells.
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Affimed has a bold vision to stop cancer from ever derailing patients’ lives. The company is led by a team of biotechnology and pharmaceutical experts dedicated to actualizing the untapped potential of the innate immune system, bringing hope to patients with cancer.
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