FDA clears IND application for immunotherapy combination to treat solid tumors
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The FDA cleared an investigational new drug application for the combination of AFM24 and SNK-01 in patients with solid tumors that express epidermal growth factor receptor, according to a joint press release from each agent’s manufacturer.
AFM24 (Affimed) is an EGFR/CD16A-directed bispecific innate cell engager. SNK-01 (NKMax America) is a nongene-edited, autologous natural killer (NK) cell therapy comprising an IV infusion of the patient’s expanded and activated NK cells. The combination therapy facilitates antitumor activity by promoting binding of innate NK cells with tumor cells via the CD16A receptor on innate cells.
“This combination is part of our overall development strategy for AFM24, the first and only innate cell engager in clinical development for solid tumors,” Andreas Harstrick, MD, chief medical officer for Affimed, said in the release.
“The mechanism of action of the two compounds could be highly synergistic [because] AFM24 has strong binding affinity to NK cells, directing them to kill tumor cells. Moreover, this combination approach represents an opportunity to supplement patients with dysregulated innate immune systems with targeted cellular therapy,” he added.
The FDA based the IND clearance on preclinical in vitro study of the combination therapy that demonstrated “enhanced activity of NK cell-induced target cell killing,” according to the release.
Affimed and NKMax America will co-sponsor a phase 1/phase 2a dose-escalation and expansion study of AFM24 and SNK-01 combination therapy among adults with solid tumors known to express EGFR. The U.S.-based, multicenter, open-label, nonrandomized clinical trial will evaluate the safety and recommended phase 2 dose of the immunotherapy combination. The phase 1 portion also will evaluate pharmacokinetics, pharmacodynamics and preliminary clinical activity. This will be followed by a phase 2a portion to evaluate preliminary efficacy of the combination therapy in selected solid tumor subtypes.
“The FDA clearance of our IND application for SNK-01 in combination with AFM24 is an important milestone for our natural killer cell therapy development program,” Stephen Chen, chief operating officer and chief technical officer of NKMax America, said in the release. “We look forward to investigating this combination as part of our comprehensive strategy aimed at producing a cell therapy for patients with advanced [or] metastatic EGFR-expressing cancers.”
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