NKGen Biotech’s history begins in 2002, when the company, originally known as ATGen, was created with the goal of becoming a global leader in immune cell therapeutics.
NKMax America undergoes key leadership changes and formalizes strategic focus
USFDA approves Affimed and NKMax America IND application to study AFM-24 and SNK01 in solid tumors
NKMax America changes corporate name to NKGen Biotech, Inc.
Leadership team strengthened with the addition of new CMO and CFO with strong success in leading biotech products to market
USFDA approves IND for Phase I/IIa trial of SNK01 in combination for treatment of advanced/metastatic HER2- or EGFR-expressing cancers
NKMax granted clearance by USFDA to expand current Phase I monotherapy trial of SNK01 to include new cohort + checkpoint inhibitors in refractory solid tumors
Signed clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer
ATGen and NKMax Korea are merged into NKMax.
NKMax America obtains a drug manufacturing license from the department of public health food and drug branch in the state of California.
NKMax America establishes a cGMP manufacturing facility for production of SNK cell therapy.
USFDA approves an IND for a Phase I trial refractory cancer.
NKMax America doses first subject in Phase I trial of SNK in patients with refractory cancer.
NKMax America initiates Phase I clinical trial of SNK in patients with psoriasis in Mexico.
NKMax America secures $11 million seed funding round.
NKMax Korea obtains the first MFDS (clinical trial application to the Korean FDA) approval for a Phase 1/2a trial for SNK + Keytruda in NSCLC patients in Korea.
Our first CLIA registered, CAP accredited clinical lab is established in Irvine, California, USA for NK Vue testing and biomarker evaluations.
Patent registration is completed for SNK (2 patents) and for the NK Vue immunosurveillance test (1 patent).
NKMax America, a wholly owned subsidiary of ATGen Global, is founded to bring life-saving immune cell therapy to the United States. Our U.S. headquarters is established in Irvine, CA.
NKMax America receives initial funding from our parent company, ATGen Global, consisting of a corporate investment in the amount of $35 M.
NKMax Korea, an affiliate of the ATGen corporation, is founded. Our Korean headquarters is located in Seongnam, a major city in the Seoul Capital Area in South Korea.
NKMax Korea acquires technology for our NK cell therapy through a patent for an innovative NK cell culture and treatment process.
ATGen, NKMax’s parent company, is publicly listed on KOSDAQ (Korean Securities Dealers Automated Quotations), a trading board of the Korea Exchange (KRX).
NK Vue, a natural killer cell activity diagnostic kit, is approved in Korea (2012) and subsequently in: Europe (CE Mark 2014); Canada (2014); Thailand (2017); Turkey (2017); Kazakhstan (2017); Indonesia (2017); Singapore (2018); Vietnam (2018).
ATGen launches its first commercial diagnostic kit, the H1N1 influenza test, allowing physicians to quickly and definitely identify the pandemic H1N1 virus in patients with flu-like symptoms.
ATGen, NKMax’s parent company, is founded. ATGen develops a proprietary stabilizing peptide, monoclonal antibodies, and recombinant proteins for research use. NKMax now produces over 500 monoclonal antibodies and over 3,900 recombinant proteins, which are being sold worldwide.