Shares of drugmaker Affimed (NASDAQ:AFMD) are up 19% at 2:06 p.m. EDT after the company disclosed positive data from an early-stage clinical trial of its innate cell engager AFM13 in patients with Hodgkin’s lymphoma.
The data release only included results from the first four patients in the study, but they were impressive nonetheless.
All four patients responded to the therapy, which included giving the patients immune cells called natural killer (NK) cells and AFM13 that attracts the NK cells to the tumor cells. Two patients had a complete response, while the other two had a partial response. Adding to the impressiveness, these patients had already failed between four and 14 different lines of therapy before being given the NK cells plus AFM13.
Three of the patients were treated with two cycles of the lowest dose level, while one patient, who had a complete response, was treated with a single cycle of the second dose level. The other complete response happened in the lower dose level after the second cycle, suggesting either a higher dose or additional exposures to the drug are helping the patient.
Equally important, the safety profile of the treatment looked good. There were no cases of cytokine release syndrome, neurotoxicity syndrome, or graft-versus-host disease, which has plagued other cell-based immunotherapies.
The data will be presented on April 13 as part of the virtual American Association for Cancer Research Annual Meeting. The company plans to go over the data during a conference call the following day. There may be some additional data release during the presentation, but mostly it’s a waiting game for Affimed’s investors to see if additional patients respond equally well. The researchers plan to enroll three more patients at the second level before moving up to the third and final planned dose level.
Affimed is running clinical trials for AFM13 in a variety of other tumor types beyond Hodgkin’s lymphoma, both alone and in combination with other drugs. Beyond AFM13, the biotech is testing AFM24 in solid tumors, and has multiple preclinical programs and a licensing deal with Roche Holding (OTC:RHHBY).
Even after today’s big jump, there’s plenty of room for additional growth for Affimed.
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