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SANTA ANA, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech, will present details on their cryopreserved allogeneic NK cell therapy platform as well as updated Phase 1 data on its use in solid tumors without lymphodepletion at the 6th Annual Allogeneic Cell Therapies Summit to be held in Boston, MA, from June 10-12, 2024.
Presentation Details:
Title: Protecting Patients by Removing Need for Lymphodepletion to Better Preserve Immune Function
Conference Track: Clinical Track
Date and Time: Wednesday, June 12, 2024, 12:00 pm ET
Dr. Song’s presentation will detail the Company’s novel allogeneic blood-derived NK cell therapy (“SNK02”) commercial manufacturing and cryopreservation process, as well provide an update on their initial Phase 1 results using SNK02 to treat patients with advanced refractory solid tumors. Furthermore, Dr. Song will explore the potential benefits of eliminating pre-treatment lymphodepletion in patients undergoing SNK02 therapy, aiming to safeguard immune function and aid in recovery. Avoiding lymphodepletion before administering cancer treatment can provide many benefits including reduced toxicity, preservation of immune function, and potentially enhancing treatment efficacy. The presentation will also include a discussion on an unexpected discovery from the SNK02 Phase 1 trial, hinting at its possible applicability as a treatment for patients beyond cancer.
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4 weeks ago
SNK02 has the potential to be a first-in-class cryopreserved allogeneic NK cell therapy for solid tumors that does not require lymphodepletion before administration, which may lead to better overall synergy in future combination regimens with immune checkpoint inhibitors.
In this Phase 1 trial, the best objective response of stable disease was demonstrated in 100% of patients that completed 8 treatment cycles of SNK02.
SNK02 was well tolerated as a monotherapy and appears to have some clinical activity against pretreated solid tumors despite the lack of lymphodepletion.
SANTA ANA, Calif., May 23, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced an online publication, titled “Interim Analysis of a Phase I Study using Cryopreserved Non-genetically Modified Allogeneic Natural Killer Cells With Enhanced Cytotoxicity (SNK02) in Patients with Advanced Solid Tumors without Lymphodepletion” at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting to be held virtually and at the McCormick Place Convention Center in Chicago, Illinois from May 31–June 4, 2024.
This Phase 1 clinical trial is a multi-center, open-label study evaluating the safety and tolerability of SNK02 in participants with pathologically confirmed solid tumors refractory to standard of care therapy. The study drug, SNK02, is a first-in-kind, cryopreserved allogeneic non-genetically modified NK cell product with significant anti-tumor cytotoxicity and over 90% expression of CD16, NKG2D, NKp46, and DNAM-1, that can be consistently produced on a large commercial scale. SNK02 was administered as an intravenous infusion (IV), weekly for eight weeks in patients with advanced solid tumors. The starting dose was 6x109 SNK02 cells. We hypothesized that higher doses of SNK02 (to overcome autodigestion) could be delivered frequently without the need for lymphodepletion and that it might demonstrate activity against solid tumors that have failed multiple prior standard-of-care treatment options. The primary endpoint was safety based on adverse events (AEs), vitals, laboratory tests, and physical exams. Tolerability of SNK02 and maximum tolerated dose were also evaluated.
“Interim data from our Phase 1 clinical study utilizing our second NK cell therapy product, SNK02, demonstrated that the treatment was well-tolerated as a monotherapy in patients with solid tumors refractory to standard of care therapy,” said Paul Y. Song, MD, Chairman and CEO of NKGen. “We are particularly excited because SNK02 has the potential to be a first-in-class cryopreserved allogeneic NK cell therapy for solid tumors that does not require lymphodepletion before administration, which may lead to better overall synergy in future combination regimens especially with immune checkpoint inhibitors where a robust T-cell response is needed. Using our proprietary allogeneic manufacturing and cryopreservation processes, we are capable of producing hundreds of thousands of potential doses of enhanced NK cell therapies from materials collected from a single donor. Thus, our potential to treat a significant number of cancer patients with SNK02 is remarkably high. We are pleased to see such promising Phase 1 trial results for both of our unique cell therapy candidates: autologous SNK01 for neurodegenerative disease and allogeneic SNK02 for cancer.”
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4 weeks ago
SANTA ANA, Calif., May 16, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen, will present highlights of the Company’s cryopreserved, autologous, non-genetically modified NK cell therapy product, SNK01, which has demonstrated enhanced cytotoxicity and activating receptor expression for the treatment of neurodegenerative diseases and solid tumors, at the 5th International Cell & Gene Therapy China Summit & Exhibition (CGCS) to be held in Nanjing, China, from May 22–24, 2024.
CGCS will showcase exclusive new data in the several areas, including solid tumor treatment, off-the-shelf therapy, innovative cell therapy, AAV gene therapy, affordability of CGT, global cooperation, RNA therapeutics, and CGT commercialization. CGCS 2024 anticipates over 6,000 global attendees, more than 200 exhibitors, greater than 200 world-class speakers from large pharma, innovative biotech, and academia.
NKGen Presentation Details:
Title: Autologous NK Cell Therapy
Session: A: Cell Therapy Focus
Section: A2: Original Innovation in Cell Therapy – Universal and Solid Tumor Treatment
Date and Time: May 23, 2024, at 4:30 PM CST (China Standard Time) UTC/GMT +8
Dr. Song’s presentation will cover a variety of important topics, including industry challenges in manufacturing autologous NK cells at scale, which has been successfully overcome by NKGen’s next-gen CMC manufacturing process in its production of its autologous NK cell therapy product, SNK01. In addition, Dr. Song will discuss the results from SNK01 treatment in combination with either immune checkpoint inhibitors in patients with advanced solid tumors, or, in combination with Erbitux in tyrosine kinase inhibitor-resistant non-small cell lung cancer.
The presentation will also include the scientific rationale and supporting data behind the use of SNK01 in neurodegenerative disease specifically emphasizing the ability of SNK01 to improve levels of amyloid beta, tau, and alpha-synuclein proteins as well as GFAP, NfL, and YKL-40, which are elevated in numerous neurodegenerative diseases including Alzheimer’s, Parkinson’s, Lewy Body Dementia, Frontotemporal Dementia, Multisystem Atrophy, and Progressive Supranuclear Palsy alluding to the potential use of SNK01 to treat these diseases or as a possible prevention in high risk asymptomatic patients with elevated biomarkers.
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1 month ago
I am encouraged by the continued promise of NKGen’s SNK01 NK cell therapy in a difficult to treat disease such as Alzheimer’s,” said Dr. Jesse Carr, MD, Medical Director of Behavioral Research Specialists, LLC in Glendale, CA who is independently overseeing the trial site. “We are seeing remarkable preliminary clinical benefit in all patients without treatment-related adverse events, including apparent improvements in cognitive function, increases in daily living activities and overall quality of life. I look forward to the potential that this novel drug candidate holds as we continue to progress the trial.”
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1 month ago
Huge news released today
SNK01, a cryopreserved, autologous enhanced natural killer cell therapy, delivered in highest dose to date, demonstrates preliminary clinical benefit without any drug-related adverse events.
Company advances SNK01 into Phase 2 in moderate Alzheimer’s disease; first patient enrolled in Phase 2 expected in Q2 2024.
SANTA ANA, Calif., May 20, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that its Safety Review Committee has cleared the Company’s cryopreserved autologous, expanded and enhanced SNK01 to progress into Phase 2 clinical development.
NKGen’s initial “proof of concept” Phase 1 study was an open label, 3+3 dose escalation study which demonstrated that even after only four doses (1, 2, or 4 billion cells) given simple IV, that SNK01 was very safe and able to cross the blood brain barrier to reduce amyloid, tau, and alpha-synuclein proteins as well as neuroinflammation in a dose responsive manner. Despite only receiving four doses, 90% of patients (median MMSE score of 14) demonstrated improvement or maintained stable cognitive function as per Alzheimer's disease composite score (“ADCOMS”).
Based on this initial pilot experience, NKGen received US FDA clearance for a new Phase 1/2a study in moderate Alzheimer’s disease using its new cryopreserved autologous product at an increased dose of 6 billion cells given every three weeks for a full-year compared to only four total doses in the initial proof-of-concept study. Three patients were enrolled in the Phase I portion to assess the safety of the higher 6 billion cell dose. In this Phase 1 portion of this trial, SNK01 was very well-tolerated, without any drug related adverse effects.
After careful review of the Phase 1 data by a majority independent Safety Review Committee, SNK01 has been cleared by an Internal Review Board (“IRB”) to enter into the Phase 2 portion of the clinical trial. This pivotal stage will assess efficacy and further safety of SNK01 in a larger group of 30 patients with moderate Alzheimer’s disease using a randomized, double-blind design (20 to receive SNK01, 10 to receive placebo). The Phase 2 trial will provide deep insights into the potential benefits and risks of SNK01 in moderate Alzheimer’s Disease, helping clinical researchers to provide validation of the potential therapeutic value of SNK01.
“We are excited to announce another important clinical milestone in our mission to advance SNK01 as the first potential disease modifying treatment of its kind for patients with more advanced Alzheimer’s disease,” said Paul Y. Song, MD, Chairman and CEO of NKGen. “The Phase 2 trial will utilize our cryopreserved SNK01 product given at the highest dose we have ever delivered, and for a full year duration. To date, SNK01 has been found to be well-tolerated with no reported drug-related adverse events. We are also very encouraged with the clinical progress we have made to date in moderate Alzheimer’s disease research and look forward to generating additional significant clinical and biomarker data from our randomized placebo-controlled Phase 2 trial.”
“I am encouraged by the continued promise of NKGen’s SNK01 NK cell therapy in a difficult to treat disease such as Alzheimer’s,” said Dr. Jesse Carr, MD, Medical Director of Behavioral Research Specialists, LLC in Glendale, CA who is independently overseeing the trial site. “We are seeing remarkable preliminary clinical benefit in all patients without treatment-related adverse events, including apparent improvements in cognitive function, increases in daily living activities and overall quality of life. I look forward to the potential that this novel drug candidate holds as we continue to progress the trial.”
Volcano
1 month ago
SANTA ANA, Calif., May 16, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen, will present highlights of the Company’s cryopreserved, autologous, non-genetically modified NK cell therapy product, SNK01, which has demonstrated enhanced cytotoxicity and activating receptor expression for the treatment of neurodegenerative diseases and solid tumors, at the 5th International Cell & Gene Therapy China Summit & Exhibition (CGCS) to be held in Nanjing, China, from May 22–24, 2024.
CGCS will showcase exclusive new data in the several areas, including solid tumor treatment, off-the-shelf therapy, innovative cell therapy, AAV gene therapy, affordability of CGT, global cooperation, RNA therapeutics, and CGT commercialization. CGCS 2024 anticipates over 6,000 global attendees, more than 200 exhibitors, greater than 200 world-class speakers from large pharma, innovative biotech, and academia.
NKGen Presentation Details:
Title: Autologous NK Cell Therapy
Session: A: Cell Therapy Focus
Section: A2: Original Innovation in Cell Therapy – Universal and Solid Tumor Treatment
Date and Time: May 23, 2024, at 4:30 PM CST (China Standard Time) UTC/GMT +8
Dr. Song’s presentation will cover a variety of important topics, including industry challenges in manufacturing autologous NK cells at scale, which has been successfully overcome by NKGen’s next-gen CMC manufacturing process in its production of its autologous NK cell therapy product, SNK01. In addition, Dr. Song will discuss the results from SNK01 treatment in combination with either immune checkpoint inhibitors in patients with advanced solid tumors, or, in combination with Erbitux in tyrosine kinase inhibitor-resistant non-small cell lung cancer.
The presentation will also include the scientific rationale and supporting data behind the use of SNK01 in neurodegenerative disease specifically emphasizing the ability of SNK01 to improve levels of amyloid beta, tau, and alpha-synuclein proteins as well as GFAP, NfL, and YKL-40, which are elevated in numerous neurodegenerative diseases including Alzheimer’s, Parkinson’s, Lewy Body Dementia, Frontotemporal Dementia, Multisystem Atrophy, and Progressive Supranuclear Palsy alluding to the potential use of SNK01 to treat these diseases or as a possible prevention in high risk asymptomatic patients with elevated biomarkers.
Volcano
2 months ago
NKGen Biotech Announces Upcoming Publication at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
Mentioned: NKGN
GlobeNewswireApril 24, 2024
SANTA ANA, Calif., April 24, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer ("NK") cell therapeutics, today announced an online publication at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting to be held virtually and at the McCormick Place Convention Center in Chicago, Illinois from May 31-June 4, 2024.
ePublication Details:
Title: Interim analysis of a phase I study using cryopreserved non-genetically modified allogeneic natural killer cells with enhanced cytotoxicity (SNK02) in patients with advanced solid tumors without lymphodepletion
Authors: Victoria Chua, Sant Chawla, Erlinda Gordon, William Feske, Lucia Hui, Hank Lee, Yoonmi Kang, Juan Mata, Katia Betito, Paul Chang, Paul Song
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