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.