Affimed NV is a clinical-stage immuno-oncology company, which engages in the discovery and development of cancer immunotherapies. The company’s proprietary ROCK platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. It operates through the Germany and USA geographical segments. The company was founded in 2000 and is headquartered in Mannheim, Germany.
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- Phase I trial results from MD Anderson Cancer Center demonstrate 92.9% overall response rate and 66.7% complete response rate in 42 heavily pretreated patients with CD30-positive lymphomas using cord blood-derived NK cells pre-complexed with AFM13. - The innovative approach combines natural killer cells with Affimed's bispecific antibody AFM13 (acimtamig), which binds to CD16A on NK cells and CD30 on lymphoma cells, enabling targeted elimination of cancer cells with a favorable safety profile. - At 20 months median follow-up, the therapy showed promising durability with 76.2% overall survival rate, with eleven patients maintaining complete response for at least 14 months and some up to 40 months post-treatment.
- Affimed's AFM24 combined with atezolizumab demonstrates meaningful clinical activity in heavily pretreated non-small cell lung cancer (NSCLC) patients, including those with EGFR mutations. - In EGFR mutant NSCLC patients, the combination therapy achieved an overall response rate (ORR) of 24% and a disease control rate (DCR) of 71%. - For EGFR wild-type NSCLC patients, the combination showed an ORR of 21% and a DCR of 76%, with a preliminary median progression-free survival (PFS) of 5.6 months. - A post-hoc analysis suggests that higher doses of AFM24 (720 mg weekly) may lead to improved efficacy, prompting its use in future development programs.
- The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Affimed's acimtamig and Artiva's AlloNK combination for relapsed/refractory Hodgkin Lymphoma. - The RMAT designation is based on early data from the LuminICE-203 trial, showing an 83.3% overall response rate and a 50% complete response rate. - The combination therapy is being evaluated in the Phase 2 LuminICE-203 trial, a multicenter, multi-cohort study. - The RMAT designation provides Affimed with enhanced access to FDA resources, potentially accelerating approval and priority review for the treatment.
