NEW YORK – Biotech company NKMax America said on Tuesday that the US Food and Drug Administration had accepted its investigational new drug application for studying its natural killer cell therapy SNK01 in combination with trastuzumab (Genentech/Roche's Herceptin) or cetuximab (Eli Lilly's Erbitux) for the treatment of advanced or metastatic HER2 or EGFR-expressing cancers.
The company now plans to start a Phase I/II open-label, multicenter trial in the third quarter of 2020.