De IND verklaring werd inderdaad in 2019 ontvangen. Als het er om gaat de maximaal toelaatbare dosis te bepalen, wat de hoofddoelstelling is, dan is Hoess nu denk ik al glansrijk geslaagd voor zijn missie. Duitsers zijn soms nogal rechtlijnig in hun taakopvatting:-)
“The IND clearance of AFM24 enables us to proceed with our planned Phase 1/2a study aimed at establishing safety and identifying initial signals of efficacy in patients with EGFR-expressing solid tumors,” said Dr. Adi Hoess, Chief Executive Officer of Affimed. “There is a tremendous need for novel immuno-oncology approaches and based on its novel mechanism of activating the innate immune system, AFM24 has the potential to address limitations, such as toxicities or resistance, associated with other EGFR-targeted therapies.”
The initial goal of the planned Phase 1/2a study is to determine the maximum tolerated dose and recommended Phase 2 dose of AFM24, as well as to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy. The second part of the study is designed to evaluate the preliminary efficacy of AFM24 in patients with select solid tumor subtypes. The study is planned to initiate in the first half of 2020.