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SANTA ANA, Calif., Oct. 17, 2022 (GLOBE NEWSWIRE) — NKGen Biotech, Inc., a biotechnology firm harnessing the facility of the physique’s immune system via the event of pure killer (NK) cell therapies, right this moment introduced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance to start a Phase 1, open-label, dose-escalation examine of its cryopreserved “off-the-shelf” allogeneic blood-derived NK cell remedy (SNK02) to judge security and tolerability in individuals with pathologically confirmed stable tumors refractory to straightforward of care remedy.
“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,” mentioned 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 scientific examine shall be a multi-center, open label, Phase 1 examine of SNK02 in sufferers with superior stable tumors who’ve failed not less than one prior normal of care remedy. The aims are to judge the security and tolerability of SNK02 and to find out the utmost tolerated dose. Initiation of the Phase 1 examine within the U.S. is predicted in Q1 2023.
NKGen Biotech’s patented manufacturing course of produces billions of NK cells with a excessive degree of purity and receptor expression whereas our cryopreservation course of permits us to take care of important cytotoxicity making SNK02 a really perfect candidate for scientific trials treating stable tumors. The firm expects to see promising scientific outcomes sooner or later because it continues to advance its cell remedy pipeline to handle areas of unmet medical wants.
About NKGen Biotech
NKGen Biotech, Inc. is a clinical-stage biotechnology firm centered on the event and commercialization of modern autologous, allogeneic, and CAR-NK Natural Killer (NK) cell therapeutics. Leveraging our proprietary cell enlargement and activation expertise and cutting-edge cell manufacturing experience, we now have the flexibility to infinitely develop pure killer cells whereas considerably enhancing cytotoxicity throughout our peripheral blood-derived merchandise. NKGen Biotech’s lead product candidate, SNK01, is at present in scientific trials for the therapy of superior refractory stable tumors each as a monotherapy and together with different brokers, together with checkpoint inhibitors and cell engagers. NKGen Biotech is dedicated to the imaginative and prescient of executing on our scientific methods with the purpose of commercializing our NK cell therapies to assist save and maintain sufferers’ lives worldwide. The firm and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA. For extra info, please go to www.nkgenbiotech.com.
Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications
949-396-6830
[email protected]
