NKGen Biotech Announces First Patient Dosed in Phase 1 Clinical Trial of Allogeneic NK Cell Therapy Product Candidate for the Treatment of Solid Tumors
NKGen Biotech, Inc. recently announced the first patient has been dosed in a Phase 1, multi-center, open-label, dose-escalation study evaluating its cryopreserved investigational allogeneic blood-derived NK cell therapy (SNK02). In October 2022, the FDA allowed NKGen’s Phase 1 SNK02 clinical trial to proceed per its Investigational New Drug application. NKGen previously announced a proposed business combination with Graf Acquisition Corp. IV (NYSE: GFOR.U, GFOR, GFOR.WS).
This Phase 1 clinical trial is evaluating the safety and tolerability of SNK02 in participants with pathologically confirmed solid tumors refractory to standard of care therapy. The study drug, SNK02, will be administered as an intravenous infusion, weekly for eight weeks. SNK02 consists of NK cells isolated from healthy donor peripheral blood mononuclear cells. NKGen’s proprietary allogeneic manufacturing process is technically capable of producing hundreds of thousands of potential doses of NK cell therapies from materials collected from a single donor. Processed SNK02 cells are expected to possess 99% purity and very high receptor expression rates. Its cryopreservation process allows the Company to maintain significant cytotoxicity, potentially making SNK02 an accessible investigational off-the-shelf candidate for clinical trials treating malignancies with an emphasis on solid tumors.
“We are excited to have dosed our first patient in the Phase 1 SNK02 clinical trial in refractory cancer patients with limited treatment options,” said Paul Y. Song, MD, CEO of NKGen. “SNK02 seeks to be one of the first cryopreserved allogeneic NK cell therapy for solid tumors that does not require lymphodepletion before administration. We believe the lack of lymphodepletion has the potential to better preserve the already fragile immune function of heavily pre-treated cancer patients with advanced disease. If successful, this therapy may lead to better overall synergy in future combination regimens with immune checkpoint inhibitors where a robust T-cell response is needed.”
For additional information on the SNK02 clinical trial, please visit www.clinicaltrials.gov using the identifier NCT05990920.
NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer cell therapies. NKGen is headquartered in Santa Ana, CA. For more information, visit www.nkgenbiotech.com.
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