NKMAX's 'Super NK' Completes US Phase 1 Clinical Trial One Month After Final Drug Administration
[Asia Economy Reporter Hyunseok Yoo] NKMAX announced on the 19th that it has completed the final patient dosing of the SuperNK immuno-oncology drug ‘SNK01’ in the US Phase 1 clinical trial and is approaching completion in one month.
The clinical trial is a Phase 1 study to confirm the dose-dependent safety of the SuperNK immuno-oncology drug ‘SNK01’. It was conducted under the leadership of Dr. Sant P. Chawla at the Sarcoma Oncology Research Center in Santa Monica, California, targeting 9 patients with refractory solid tumors who did not respond to existing treatments.
The abstract of the interim results of this US Phase 1 clinical trial was released on June 13 at ASCO 2020 (American Society of Clinical Oncology). The released abstract mentioned the interim safety results for 5 out of the total 9 patients enrolled in the US Phase 1 trial. No adverse reactions related to SuperNK were observed in the 5 patients who received SuperNK, and no cytokine release syndrome was confirmed. Despite the patients having rapidly progressing metastatic solid tumors, it was reported that after administration of SuperNK, quality of life improved and tumor size did not increase, indicating therapeutic efficacy. Although these are interim results for 5 out of 9 patients, no abnormalities have been found in the remaining 4 patients so far, and the company expects the main clinical trial to be completed smoothly in one month.
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Dr. Paul Song, Vice President of NKMAX’s US branch, stated, “We are confirming dose-dependent safety by administering 1 billion, 2 billion, and 4 billion SuperNK cells alone. The main clinical trial will be completed and results confirmed after a one-month follow-up period.” He added, “Based on these safety results, we plan to apply to the US FDA in the second half of this year for a Phase 2 clinical trial administering SuperNK to patients with sarcoma and triple-negative breast cancer, diseases with no suitable treatments and very high unmet medical needs.”
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