NKMAX Receives US FDA Approval for Phase 1/2a Clinical Trial of Super NK+ Targeted Cancer Drug Combination

[Asia Economy Reporter Hyungsoo Park] NKMAX announced on the 2nd that it has received approval from the U.S. Food and Drug Administration (FDA) for a Phase 1/2a clinical trial combining SuperNK (SNK01) with targeted anticancer drugs for the treatment of metastatic and advanced solid tumors.

The trial will be conducted at multiple institutions in the U.S. involving 154 patients with metastatic and advanced solid tumors positive for HER2 or EGFR who are unresponsive to existing treatments. The targeted anticancer drugs combined with SuperNK (SNK01) are Herceptin (generic name: trastuzumab) or Erbitux (generic name: cetuximab).

The clinical trial is divided into two phases, setting drug safety and efficacy as the primary evaluation criteria to be confirmed simultaneously. In the first phase, 24 patients will be enrolled to assess dose-limiting toxicity (DLT) in Phase 1 and to determine the recommended Phase 2 dose (R2PD). In the second phase, a total of 130 patients will be evaluated for objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) following combination therapy.

Yongman Kim, Director of Research at NKMAX, stated, "NK cells have the ability to kill cancer cells autonomously without specific antigens." He added, "They also recognize antibody therapeutics (IgG1) bound to cancer cell surface antigens through the CD16 receptor on the cell surface and exert direct cytotoxic effects via antibody-dependent cellular cytotoxicity (ADCC)."

SuperNK, manufactured using NKMAX's proprietary technology, exhibits a high CD16 expression rate, which is expected to enhance the ADCC effect of NK cells.

Director Kim said, "We confirmed that the combination of SuperNK with the targeted anticancer drugs Erbitux or Herceptin improved cancer cell killing effects in EGFR-positive lung and skin cancer cell lines and HER2-positive breast cancer cell lines." He added, "We expect that clinical trials combining SuperNK with targeted anticancer drugs will improve clinical anticancer efficacy."

This content was produced with the assistance of AI translation services.