Affimed provides data update from Phase 1/2a trials of AFM24

Affimed announced data updates from two phase 1/2a trials with AFM24, the company’s tetravalent, bispecific innate cell engager, in patients with solid tumors. AFM24 binds both EGFR on tumor cells and CD16A on natural killer cells and macrophages, thereby facilitating the killing of EGFR-positive tumor cells. Abstracts for the upcoming data presentations at the 37th Annual Meeting of the Society for Immunotherapy of Cancer were published today. Poster Number 729: Targeting Epidermal Growth Factor Receptor- Expressing Solid Tumors With AFM24, A Novel CD16A Bispecific Innate Cell Engager: Comprehensive Correlative Science Findings From A Phase 1 Study The first poster presentation includes correlative science findings from the phase 1 part of the ongoing monotherapy phase 1/2a study evaluating the safety and efficacy of AFM24 in patients with metastatic, treatment-refractory EGFR-positive solid tumors. In total, 35 patients with a range of tumor types were treated to date including patients with colorectal cancer, non-small cell lung cancer and other solid tumors were treated.NK cells in peripheral blood showed upregulation of activation markers which coincided with transient loss of NK cells from peripheral blood. This indicates migration of NK cells to the tumor. In addition, cytotoxic CD8-positive T-cell levels increased in the tumor, pointing to a crosstalk with the adaptive immune system. In all patients, AFM24 monotherapy demonstrated a well-managed safety profile. Poster Number 745: AFM24 and atezolizumab combination in patients with advanced epidermal growth factor receptor-expressing solid tumors: Initial results from the Phase 1 dose-escalation stud The second poster to be presented at SITC will include a data update from the phase 1/2a combination study evaluating AFM24 together with Roche’s PD-L1 checkpoint inhibitor atezolizumab in patients with advanced, treatment-refractory EGFR+ solid tumors. The aim of the two-part study is to establish the recommended phase 2 dose of AFM24 in combination with atezolizumab as well as to assess initial data on the efficacy and safety of AFM24 in combination with atezolizumab. So far, four patients with gastric or pancreatic adenocarcinomas have been enrolled in the first dose cohort, with three completing the safety lead-in phase and receiving 160 mg AFM24 and atezolizumab. The preliminary data indicate that the combination of AFM24 and atezolizumab is a promising approach, with no dose-limiting toxicities observed. Among three patients evaluated in cohort 1, clinical activity was observed in two patients, while one patient awaited tumor assessment at cut-off date. One ongoing partial response was observed in a patient with gastric cancer and skin metastases who had rapidly progressed following four prior lines of therapy, including a PD-1 inhibitor, and an ongoing stable disease at 4+ months with symptomatic improvement was observed in a patient with pancreatic adenocarcinoma. Dose escalation is proceeding with an AFM24 dose of 480 mg.