NKGen Biotech Announces Appointment of Chief Financial Officer

SANTA ANA, Calif., February 24, 2023 — NKGen Biotech, a biotechnology company harnessing the power of the body’s immune system through the development of natural killer cell therapies, announces the appointment of Benson Fong as Chief Financial Officer. Mr. Fong is a highly accomplished CFO who brings an extensive background of financial experience to NKGen Biotech in areas of corporate finance, collaborations, and licensing.  Mr. Fong’s demonstrated expertise will be instrumental in directing the Company’s financial strategies and identifying and guiding financing efforts.

Mr. Fong brings more than three decades of senior financial leadership and corporate development experience. Mr. Fong is the Managing Director of Nehalem Advisory, LLC guiding several life science startups with their financial strategy and implementation. He also collaborates with Potrero Hill Advisors. Before joining Nehalem Advisory, he was consulting CFO and Account Director at Engine Room and CFO at Early Growth Financial Services. Previously, he served as President and CEO of Lapis Therapeutics as well as Senior VP Corporate Development at CoTherix where he was responsible for in-licensing Ventavis® (iloprost) which was later FDA approved and successfully launched.

Prior experience included serving as the first VP for venture debt lending at Imperial Bank/Comerica, CFO at Cibus Pharmaceutical, Controller at Matrix Pharmaceuticals, and Division Controller in Express Banking at Wells Fargo Bank. Mr. Fong started his career as a senior tax accountant and CPA at Arthur Young & Co. Mr. Fong has a successful track record in negotiation including licensing agreements, R&D sponsored research, manufacturing and lease agreements. His leadership responsibilities have included filing S-1s, equity and debt financing, and product licensing.  Mr. Fong received a B.S. in Biology from the University of Oregon.

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. SNK02, our allogeneic NK cell therapy, has received USFDA IND clearance for initiating clinical trials in solid tumors. 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.

Contacts:

Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications
949-396-6830
dchua@nkgenbiotech.com

NKGen Biotech Appoints Paul Y. Song, MD as Chief Executive Officer

SANTA ANA, Calif., January 10, 2023 — NKGen Biotech, a biotechnology company harnessing the power of the body’s immune system through the development of natural killer cell therapies, today announced the appointment of Paul Y. Song, MD as Chief Executive Officer (CEO) and Vice Chairman of the Board of Directors, effective January 10, 2023.

“We are thrilled to welcome Paul as our new CEO and the experience, vision and leadership Paul brings to NKGen Biotech,” said Sangwoo Park, Founder and Chairman of NKGen Biotech. “Paul will play a critical role in leading our company’s corporate strategy and the advancement of our potentially life-changing clinical portfolio in oncology and neurodegenerative disease. Paul’s passion for helping patients along with his focused expertise in NK cell therapeutics will provide NKGen with the guidance it needs to successfully meet its milestones and continue to show significant progress towards commercialization.”

” I am honored to lead NKGen at this pivotal time as the Company advances its novel NK cell therapies through the clinic and in new disease indications,” stated Paul Y. Song, MD, CEO of NKGen Biotech. “I strongly believe in the Company’s science and platform, unmatched manufacturing expertise, and talented leadership team making NKGen uniquely positioned to expand the overall NK cell therapy market well beyond oncology. NKGen has several key milestones on the immediate horizon in 2023 for both our autologous SNK01 and our allogeneic SNK02 NK cell therapy, and I am very optimistic that we will soon be able to show the true potential of our enhanced NK cell products to address a high unmet need for disease modifying treatment in advanced cancers and neurodegenerative diseases.”

Dr. Song has nearly 25 years of experience as a biopharma executive, clinician, and translational medicine expert. Most recently, Dr. Song served as Co-founder and CEO at FuseBio Therapeutics, a company developing immune modulating therapies for cancer. Prior to FuseBio he was Chief Medical Officer at NKMax America leading the NK cell therapy clinical program strategy; CMO at Cynvenio Biosystems, a clinical stage genomic peripheral blood monitoring company; and CMO/Senior Advisor for Berg Health. Before joining the pharmaceutical industry, Dr. Song was an attending physician at Cedars-Sinai Medical Center’s Samuel Oschin Cancer Center.

Dr. Song is a board-certified Radiation Oncologist with expertise in translational medicine, clinical trials, and therapeutic development within oncology and immunology. He graduated with honors from the University of Chicago and received his M.D. degree from The George Washington University. Dr. Song completed his residency in radiation oncology at the University of Chicago where he served as Chief Resident and completed a brachytherapy fellowship at the Institute Gustave Roussy in Villejuif, France. He was also awarded an ASTRO research fellowship in 1995 for his research in radiation inducible gene therapy.

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 (autologous NK cell therapy) 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. SNK02 (allogeneic NK cell therapy) received IND clearance in 4Q2022 with clinical trials planned in 2023. 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.

 

Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications
949-396-6830
dchua@nkgenbiotech.com

NKGen Biotech Announces Collaboration with the Parkinson’s Foundation to Bring Its Novel Natural Killer Cell Therapy to the Clinic for Advanced Parkinson’s Disease

SANTA ANA, Calif., November 4, 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 a collaboration with the Parkinson’s Foundation that will focus on ways to help accelerate NKGen’s clinical program using its novel autologous NK cell therapy (SNK01) for the treatment of advanced Parkinson’s disease (PD) through its network of clinical partners and donors.

 

“Recent research has shown that NK cells can help remove alpha-synuclein proteins, reduce autoreactive T cell generated inflammation, and remove damaged neurons. We believe our non-genetically modified, enhanced, and expanded NK cells (SNK01) can provide an entirely new therapeutic approach to Parkinson’s disease which currently lacks effective disease modifying modalities,” said Paul Y. Song, MD, Vice Chairman of NKGen Biotech. “We are very impressed with the Parkinson’s Foundation’s holistic approach towards improving patient care and supporting cutting-edge research. We are confident that they will be a great partner for us as we bring our treatment for Parkinson’s disease to the clinic in 2023.”

 

“The Parkinson’s Foundation has a strong commitment to identify and accelerate promising scientific breakthroughs in the treatment of PD,” said John L. Lehr, President and CEO of the Parkinson’s Foundation. “We are looking to support novel innovative approaches in PD, and we are attracted to NKGen’s unwavering commitment to bring their NK cell therapy to the clinic very quickly.”

 

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 innovative 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.

About the Parkinson’s Foundation
The Parkinson’s Foundation makes life better for people with Parkinson’s disease by improving care and advancing research toward a cure. In everything we do, we build on the energy, experience, and passion of our global Parkinson’s community. Since 1957, the Parkinson’s Foundation has invested more than $400 million in Parkinson’s research and clinical care. Connect with us on Parkinson.org, Facebook, Twitter, Instagram or call (800)4PD-INFO (473-4636).

Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications
949-396-6830
dchua@nkgenbiotech.com

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.

 

Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications
949-396-6830
dchua@nkgenbiotech.com

NKGen Biotech Announces Publication in Journal of Cancer Research and Cellular Therapeutics on Durable Response for SNK01 in Advanced Sarcoma

SANTA ANA, Calif., September 21, 2022 — NKGen Biotech, a biotechnology company harnessing the power of the body’s immune system through the development of natural killer cell therapies,  today announced a publication in the peer-reviewed Journal of Cancer Research and Cellular Therapeutics entitled “Durable responses using SNK01 autologous enhanced natural killer cells and pembrolizumab for chemotherapy-resistant advanced sarcoma: Case reports, review of literature, and future perspectives.

The paper by Gordon et al. discloses enduring response data in chemotherapy resistant metastatic sarcoma patients who were treated with SNK01, autologous enhanced natural killer cell therapy, and pembrolizumab, an immune checkpoint inhibitor, along with a review of literature and future perspectives on the use of SNK01 in advanced sarcoma.

“We are pleased to be able to share the promising results of our SNK01 natural killer cell therapy in combination with pembrolizumab, in these two important case studies since metastatic sarcoma is typically associated with poor outcomes when treated with standard regimens,” commented Paul Song, M.D., Vice Chairman of NKGen Biotech. “It is encouraging to see that Patient #1, despite being PD-L1 negative and having failed prior pembrolizumab, eventually showed a gradual tumor reduction with a 47% partial response, after which the patient underwent two surgical resections and achieved a sustained remission. Of note is that the patient has safely been on this regimen for almost 35 months without any toxicity at all and remains no evidence of disease.”

“Patient #2 has low PD-L1 expression and had failed prior nivolumab. The patient showed a gradual reduction in tumor size, achieving a 38% partial response,” added Dr. Song, “This response data is very promising especially since both patients had failed prior immune checkpoint inhibitor therapy. It appears that SNK01 might be able to change the tumor microenvironment and suggests that SNK01 plus pembrolizumab has the potential to be a viable therapeutic option for patients with metastatic sarcoma, and especially in PD-L1 negative and low expressing tumors. Further studies are warranted, and we look forward to confirming these findings in a Phase II clinical trial.”

The encouraging data from these two case reports suggests SNK01 combined with pembrolizumab may be a viable salvage therapy regimen for chemotherapy-resistant advanced sarcoma with manageable toxicity. The data also supports existing evidence that natural killer cells mediate a favorable response to immune checkpoint inhibitor therapy while reducing immune-related adverse events.

 

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.

 

Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications
949-396-6830
dchua@nkgenbiotech.com

NKGen Biotech to Present at the Baird 2022 Global Healthcare Conference

SANTA ANA, Calif., September 7, 2022 — NKGen Biotech, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, today announced that its senior management will present at the Baird 2022 Global Healthcare Conference on Wednesday, September 14, 2022, in New York City.   Please see details below:

Baird Global Healthcare Conference
Format: Company presentation
Date: Wednesday, September 14, 2022
Time: 2:35 pm ET
Location: New York, NY
Registration:  Conference link

NKGen Biotech will also hold one-on-one investor meetings. To schedule a meeting, please contact your Baird representative.

 

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.

 

Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications
949-396-6830
dchua@nkgenbiotech.com

NKGen Biotech To Present SNK01 Clinical Data at the European Society for Medical Oncology (ESMO) Congress 2022

SANTA ANA, Calif., September 6, 2022 – NKGen Biotech, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, today announced that compassionate use cases of SNK01 + an immune checkpoint inhibitor in patients with advanced sarcoma have been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Annual Congress being held in Paris, France, September 9 – 13, 2022.

Poster Presentation

Title: USFDA Authorized Compassionate Use of SNK01 (Autologous Non-Genetically Modified Natural Killer Cells with Enhanced Cytotoxicity) and Checkpoint Inhibitors in Advanced Heavily Pre-treated Sarcoma: A Promising Regimen.
Poster #: P757
Date and Time: September 10, 2022, 10:38 am CEST
Poster Session:  13
Location:  Paris Expo Porte de Versailles; Poster Area, Hall 4

Promising data aggregated from eight USFDA approved compassionate use IND cases from metastatic sarcoma patients who received SNK01 combined with a checkpoint inhibitor will be disclosed during the poster presentation. The combination of SNK01 and a checkpoint inhibitor appears to have clinical activity against several types of heavily pre-treated advanced sarcomas, independent of PD-L1 status. The data also suggests that repeated dosing with the combination appears to be safe and well-tolerated.

More information on the ESMO Congress 2022 can be found at the following link: https://www.esmo.org/meetings/esmo-congress-2022

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.

Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications
949-396-6830
dchua@nkgenbiotech.com

Yong Ben, M.D. Joins NKGen Biotech as Scientific and Clinical Advisor

SANTA ANA, Calif., August 3, 2022 — NKGen Biotech, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, today announced that Yong Ben, M.D. has joined the company as a scientific and clinical advisor providing expertise to the company to accelerate the progress of its natural killer cell therapy (SNK) program as a potential treatment for solid tumors and neurodegenerative disorders.

Dr. Ben has over two decades of deep and diverse clinical development expertise including strategic planning, oncology clinical trial design and execution (phase I-IV), and successful BLA/NDA submissions. Under his leadership and direction, several oncology drug candidates were approved including a PD-1 antibody for over seven tumor types, a PARP inhibitor for ovarian cancer, a PD-L1 antibody for urothelial cancer, a proteasome inhibitor for multiple myeloma, a tyrosine kinase inhibitor for renal cancer, and oncolytic virus for head and neck cancers.

“We are excited to have Dr. Ben join us as a scientific and clinical advisor given his extensive experience in leading successful clinical development programs in the oncology and hematology space,” commented Sangwoo Park, Chairman and CEO of NKGen Biotech,” We look forward to Dr. Ben’s guidance in developing a robust clinical strategy to further advance our SNK clinical programs with the intent to offer a therapy that provides real improvements in therapeutics outcomes for cancer patients.”

Until recently, Dr. Ben served as CMO, Solid Tumors, for BeiGene, a global biotechnology company and previously CMO at BioAtla, a San Diego immunotherapy company. Prior, Dr. Ben was the Global Clinical Lead, Immuno-Oncology at AstraZeneca, leading the approval of durvalumab. Prior to AstraZeneca, Dr. Ben led multiple oncology programs including ixazomib pivotal program that led to an approval in multiple myeloma as well as orteronel and alisertib programs at Millennium Pharmaceuticals, and axitinib which was approved in renal cell carcinoma at Pfizer.

Dr. Ben received his medical degree from Norman Bethune College of Medicine and was a surgical oncologist at Peking Union Medical College Hospital with a post-doc fellowship at California Pacific Medical Center. Dr. Ben earned an MBA from the University of California, San Diego.

 

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.

 

Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications
949-396-6830
dchua@nkgenbiotech.com

NKGen Biotech to Participate in Truist Securities Cell Therapy Symposium

SANTA ANA, Calif., June 21, 2022 — NKGen Biotech, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, today announced that senior management will be hosting one-on-one meetings at the Truist Securities Cell Therapy Symposium – symposia-cel being held in person in New York City on Tuesday, June 28, 2022. Details on the symposium can be found below.

Truist Securities Cell Therapy Symposium – symposia-cel (in person)
Format: Symposium and 1 x 1 meetings
Date: Tuesday, June 28, 2022
Meeting Times: 12:30 pm – 5:00 pm EDT
Location: New York, NY
Registration: Event website

If you are interested in arranging a 1 x1 meeting with NKGen Biotech, please contact your Truist representative.

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.

Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications
949-396-6830
dchua@nkgenbiotech.com

NKGen Biotech To Present SNK01 Clinical Data at the 2022 ASCO Annual Meeting

SANTA ANA, Calif., May 26, 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 clinical data from its ongoing SNK01 (NK cell therapy) phase I trial, in patients with advanced solid tumors, will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 3 – 7, 2022 in Chicago, Illinois.

Results will be presented in a poster discussion entitled: Interim analysis of a phase I study of SNK01 (autologous non-genetically modified natural killer cells with enhanced cytotoxicity) and avelumab in advanced refractory sarcoma (abstract: 11517; poster: 422), on Sunday, June 5, 2022, 8:00 am – 11:00 am; Discussion 11:30 am – 1:00 pm CDT; Sarcoma session, sarcoma track, Room S404.
The SNK01 phase I, open label, dose escalation trial (NCT03941262), in patients with advanced solid tumors refractory to conventional treatment, demonstrated antitumor activity and an acceptable safety profile.

Key highlights

  • SNK01 combined with avelumab showed efficacy in 17 advanced stage cancer patients (all heavily pre-treated with a median of 5 lines of prior therapy)
    • Best ORR is 11.7% with 2 PR and 6 SD*
    • Median PFS is 11.3 weeks; four patients (23.5%) have PFS of > 41 weeks
    • Median OS is 24.9 weeks
    • PFS and OS are expected to increase as patients continue on the trial
  • SNK01 combined with avelumab was safe and well-tolerated and appears to have some clinical activity against several types of heavily pre-treated advanced sarcomas, independent of PD-L1 status
  • SNK01 may also keep rapidly progressing disease stable while allowing additional treatment with cytotoxic chemotherapy

Two additional posters will also be presented at the 2022 ASCO Annual Meeting:

  • Preliminary analysis of a phase I study of SNK01 (Autologous non-genetically modified natural killer cells with enhanced cytotoxicity) monotherapy in patients with advanced solid tumors (abstract: 2644, poster: 298)
  • The combination of CD16A/EGFR innate cell engager, AFM24, with SNK01 autologous natural killer cells in patients with advanced solid tumors (abstract: TPS2675, poster: 326b)

Abstracts presented at the 2022 ASCO Annual Meeting can be found at www.asco.org

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.

Contact
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications
949-396-6830
dchua@nkgenbiotech.com

*corrected typo to match actual poster presented at ASCO22,  previously reported as 7 SD