NKMAX Submits IND for Combination Targeted Cancer Therapy Clinical Trial to US FDA

[Asia Economy Reporter Oh Joo-yeon] NKMAX announced on the 6th that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1/2a clinical trial combining the immune cell therapy SuperNK (SNK01) with targeted anticancer drugs to enhance therapeutic efficacy.

The targeted anticancer drugs combined with the immune cell therapy SuperNK are Herceptin® or Erbitux®. If approval is granted by the U.S. FDA within a month for this application, NKMAX will add combination therapy clinical trials with targeted anticancer drugs to its autologous immune cell therapy pipeline. The Phase 1/2a trial will enroll a total of 154 patients, with 66 patients receiving Herceptin combination therapy and 88 patients receiving Erbitux combination therapy.

Yongman Kim, Head of Research at NKMAX, explained, "Antibody-dependent cellular cytotoxicity (ADCC) is one of the mechanisms by which NK cells kill cancer cells. The CD16 receptor on NK cells recognizes antibodies (IgG1) bound to cancer cell surface antigens, thereby exerting anticancer effects." He added, "The targeted anticancer drugs applied in this clinical trial, Herceptin and Erbitux, are IgG1 antibody therapies that recognize the HER2 and EGFR receptors on the surface of cancer cells, respectively." He further stated, "When combined with SuperNK, which expresses very high levels of CD16, the ADCC function of NK cells enhanced by their cancer cell killing ability is expected to improve the response rate of existing targeted anticancer drugs."

Kim said, "Herceptin is a targeted anticancer drug prescribed for HER2-positive cancer patients, with a global annual sales market of approximately 8.6 trillion KRW (7 billion USD)." He continued, "HER2 positivity appears in 15-30% of breast cancer patients and 10-30% of gastric and esophageal cancer patients, among various cancers. However, the therapeutic effect of the drug is limited to some patients due to differences in receptor expression levels or the degree of NK cell ADCC function. Similarly, Erbitux, used for EGFR-positive cancer patients, has a global annual sales market of 11.6 trillion KRW (9.5 billion USD), but faces the same limitations."

He expressed expectations, saying, "If favorable results are obtained from this combination therapy clinical trial, SuperNK (SNK01) will demonstrate its potential as a combination therapy that can improve and complement the limitations of targeted anticancer drugs that are effective only in some patients. Additionally, it will be an opportunity to recognize the excellence of SuperNK."

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