On January 7, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported an update on its pipeline and business (Press release, Affimed, JAN 7, 2021, View Source,on%20its%20pipeline%20and%20business. [SID1234573670]). "Affimed ended 2020 with significant momentum across all major programs and a strong balance sheet that provides cash runway into the first half of 2023," commented CEO Adi Hoess. "With three innate cell engagers in clinical development and multiple active collaborations, Affimed is positioned for numerous catalysts in 2021 and beyond."
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Clinical Stage Program Updates
AFM13 (CD30/CD16A ICE)
AFM13-202, a Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with CD30-positive peripheral T-cell lymphoma (pTCL), remains ahead of schedule and Affimed expects to complete the interim data analysis during the first half of 2021.
The first dose cohort of AFM13-104, an investigator sponsored Phase 1 study at The University of Texas MD Anderson Cancer Center evaluating the tolerability and efficacy of AFM13 preloaded cord blood-derived NK cells (cbNK) followed by weekly AFM13 monotherapy in patients with refractory CD30 expressing lymphomas, is ongoing.
AFM24 (EGFR/CD16A ICE)
AFM24-101, a Phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted ICE for treatment of patients with EGFR-expressing solid tumors, has completed dose cohort 3 (80 mg per patient) without showing dose limiting side effects and patients are currently being enrolled and treated in dose cohort 4 (160 mg per patient).
Affimed and NKMax America completed a pre-IND meeting with the U.S. Food and Drug Administration in December 2020. The companies plan to submit an IND in the first half of 2021 for a Phase1/2a study to investigate different dose levels of AFM24 in combination with NKMax America’s autologous NK cell product SNK01 in patients with EGFR expressing solid tumors.
Other Business Updates
As of December 31, 2020, Affimed’s preliminary unaudited cash and cash equivalents were approximately €147 million. Based on its current operating plan and assumptions, Affimed anticipates that its cash and cash equivalents will support operations into the first half of 2023.