Affimed updates on clinical studies and cash balances
Affimed N.V. (NASDAQ:AFMD) reports cash and cash equivalents of ~€147M as of Dec. 31st, that provides cash runway into the first half of 2023.
Clinical stage program, AFM13 (CD30/CD16A ICE), 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. The company expects to complete the interim data analysis during the 1H21.
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.
Hopelijk wordt er nog lang gewacht met het aanspreken van die shelf offering, tenzij er een enorme koerssprong aan vooraf is gegaan. Met 147 M in kas zou dat geen probleem mogen zijn, maar met Adi weet je het nooit. ;-)