Affimed submits IND application to FDA for first-in-human 1/2a study of AFM24
Affimed announced the submission of an Investigational New Drug, or IND, application to the FDA to initiate a first-in-human Phase 1/2a study of AFM24. The initial goal of the 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 in patients with advanced cancers known to express the epidermal growth factor receptor, EGFR. The second part of the study will evaluate the preliminary efficacy of AFM24 in patients with select solid tumor subtypes. Affimed also announced that the FDA has cleared an IND application for a Phase 1 study to evaluate a stable complex of AFM13, its lead innate cell engager, pre-mixed with cord blood-derived allogeneic NK cells as an investigational treatment for patients with relapsed/refractory CD30-positive lymphoid malignancies. In addition, the registration-directed study of AFM13 as monotherapy in relapsed/refractory peripheral T cell lymphoma (pTCL), where patients have very few treatment options, is on track to initiate this year.