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.
"NK cells play a vital role in antibody-dependent cell-mediated cytotoxicity directed killing of cancer cells, and some of the poor responses to trastuzumab and cetuximab can be attributed to the inherent weakness of the innate immune system of treated patients," NKMax America CMO Paul Song said in a statement. "Our preclinical research highlights our ability to exponentially increase NK cell cytotoxicity and generate high CD16 expression to optimize the antibody-dependent cell-mediated cytotoxicity pathway helping to overcome these limitations."
Early data also suggested that SNK01 can cross the blood-brain barrier, and the team wants to observe if the therapy will be effective in treating HER2- or EGFR-mutated patients with brain metastases.
In January, the FDA approved Acepodia's IND for antibody natural killer cell-conjugated therapy in HER2-expressing tumors.