NKGen Biotech Receives IND Clearance from FDA for SNK02 Allogeneic Natural Killer Cell Therapy for Solid Tumors

SANTA ANA, Calif., October 17, 2022 — NKGen Biotech, Inc., a biotechnology company harnessing the power of the body’s immune system through the development of natural killer (NK) cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance to commence a Phase 1, open-label, dose-escalation study of its cryopreserved “off-the-shelf” allogeneic blood-derived NK cell therapy (SNK02) to evaluate safety and tolerability in participants with pathologically confirmed solid tumors refractory to standard of care therapy.

“We are excited to be able to proceed with our SNK02 clinical trial plans for treating refractory cancer patients who are left with limited options,” said Paul Song, M.D., Vice Chairman of NKGen Biotech. “I believe that SNK02 is the first cryopreserved allogeneic NK cell therapy that does not require lymphodepletion before administration unlike other cell therapies. This clearance for SNK02 is an important milestone in our pursuit to bring life-changing therapies to cancer patients and will be our second clinical NK cell therapy program focusing on solid tumors, following our SNK01 autologous product entering Phase 2 studies next year.”

The SNK02 clinical study will be a multi-center, open label, Phase 1 study of SNK02 in patients with advanced solid tumors who have failed at least one prior standard of care therapy. The objectives are to evaluate the safety and tolerability of SNK02 and to determine the maximum tolerated dose. Initiation of the Phase 1 study in the U.S. is expected in Q1 2023.

NKGen Biotech’s patented manufacturing process produces billions of NK cells with a high level of purity and receptor expression while our cryopreservation process allows us to maintain significant cytotoxicity making SNK02 an ideal candidate for clinical trials treating solid tumors. The company expects to see promising clinical results in the future as it continues to advance its cell therapy pipeline to address areas of unmet medical needs.

About NKGen Biotech

NKGen Biotech, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK Natural Killer (NK) cell therapeutics. Leveraging our proprietary cell expansion and activation technology and cutting-edge cell manufacturing expertise, we have the ability to infinitely expand natural killer cells while significantly enhancing cytotoxicity across our peripheral blood-derived products. NKGen Biotech’s lead product candidate, SNK01, is currently in clinical trials for the treatment of advanced refractory solid tumors both as a monotherapy and in combination with other agents, including checkpoint inhibitors and cell engagers. NKGen Biotech is committed to the vision of executing on our clinical strategies with the goal of commercializing our NK cell therapies to help save and sustain patients’ lives worldwide. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA. For more information, please visit www.nkgenbiotech.com.


Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications