NKMAX, Super NK Clinical Trial Receives Special Approval from US FDA..."Shortening Clinical Development Period"

[Asia Economy Reporter Hyunseok Yoo] NKMAX announced on the 1st that it will add Cohort 4 to the ongoing SuperNK (SNK01) immuno-oncology drug Phase 1 clinical trial in the United States and change it to a combination therapy clinical trial with immune checkpoint inhibitors.

NKMAX has completed IND approval from the US FDA for adding Cohort 4, which combines the immune checkpoint inhibitors Keytruda (pembrolizumab) and Bavencio (avelumab), and plans to recruit an additional 18 patients. Cohort 4 will be conducted on patients with refractory cancers who do not respond to existing treatments, similar to previous cohorts. This includes patients who showed no therapeutic effect from immune checkpoint inhibitors.

NKMAX discovered therapeutic potential in some refractory cancer patients who received SuperNK monotherapy in the previous US clinical trial and conducted compassionate use administration of SNK01 combined with Keytruda. As excellent therapeutic effects were observed, the US FDA recommended adding a cohort, and the company stated that despite not submitting preclinical data, it received an exceptional special approval from the US FDA for the clinical trial content.

Paul Y. Song, Vice President of NKMAX America, said, “The US FDA recommended adding a cohort without separate processes such as preclinical studies to expedite patient treatment. If we proceed by adding only the combination therapy cohort to the existing trial, NKMAX can shorten the clinical development period by at least one year, from preclinical to re-approval of clinical trials.” He added, “We expect the SuperNK immuno-oncology drug to become a leading NK cell therapy recognized in the US market.”

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