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NKGen Biotech Presents Updated NK Cell Therapy Data for Neurodegenerative Disease at the 12th Annual Alzheimer's & Parkinson's Drug Development Summit
Mentioned: NKGN
GlobeNewswireApril 25, 2024
In vitro studies with SNK01 have shown a direct ability to phagocytose and digest amyloid and alpha-synuclein proteins while also secreting immunoregulatory cytokines and identifying and eliminating autoreactive T cells that contribute to neuroinflammation.
SNK01 autologous NK cell therapy demonstrated a positive effect on improving cerebral spinal fluid ("CSF") and plasma levels of Tau, amyloid, and alpha-synuclein proteins in Alzheimer's patients suggesting a potential larger application in the treatment of other neurodegenerative diseases associated with these proteins.
90% of patients enrolled in the proof-of-concept Phase 1 Alzheimer's trial had improved or stable cognitive function at week 11 using the composite ADCOMS score.
SNK01 was also found to reduce neuroinflammation, showing improved levels of Glial Fibrillary Acid Protein (GFAP) in most patients, Neurofilament-light (NfL), Growth/Differentiation Factor-15 (GDF15), and Latent Transforming Growth Factor Beta Binding Protein 2 (LTBP2), suggesting a potential preventative clinical application for SNK01.
NKGen submitted an IND for SNK01 in Parkinson's disease ("PD") in Q1 2024 and anticipates to begin enrollment for its Phase 2 trial in advanced Alzheimer's disease ("AD") in Q2 2024.
SANTA ANA, Calif., April 25, 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 the details disclosed in today's presentation by Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen, entitled "Evaluating Adoptive Cellular Immunotherapy for Neurodegeneration with Autologous SNK01", in which the Company shared additional information on the scientific rationale, preclinical and clinical data to date on the use of SNK01 enhanced NK cell therapy in patients with advanced AD and PD.
The presentation highlighted preclinical data showing the ability of SNK01 to phagocytose and digest both amyloid and alpha-synuclein proteins, the ability to secrete cytokines, which are able to inactivate inflammatory cells, as well as the ability to reduce autoreactive T cells, which have been implicated as a significant contributor to neuroinflammation and damage. In addition, compassionate use case studies of patients with advanced Alzheimer's disease and Parkinson's disease treated with SNK01 were presented as well as an update from the Company's Phase 1 Alzheimer's trial.
In the Phase 1 AD trial, SNK01 was administered intravenously ("IV") every three weeks for a total of four treatments using a 3+3 dose escalation design (1, 2, and 4 x 109 cells) in patients with either mild, moderate, or severe AD (Median MMSE of 14). Cognitive assessments and extensive CSF/plasma biomarker analyses were performed at baseline and at 1 and 12 weeks after the final dose. The primary endpoint was safety and secondary endpoints included changes in cognitive assessments and biomarker levels.
SNK01 was found to reduce and/or improve levels of pTau, amyloid AB42/40, and alpha-synuclein protein biomarkers suggesting that it could have utility far beyond Alzheimer's. 90% of patients enrolled in the proof-of-concept Phase 1 had improved or stable cognitive function at week 11 using the composite ADCOMS score.
In the presentation, Dr. Song commented, "While elevated amyloid AB42/40 is primarily implicated in Alzheimer's, alpha-synuclein protein levels have been noted in several other neurodegenerative diseases as well, including Parkinson's, Lewy Body Dementia, Multiple System Atrophy, and Pure Autonomic Failure. In addition, elevated Tau levels have been associated with Frontotemporal Dementia, Progressive Supranuclear Palsy, and Corticobasal Degeneration. We believe the ability of SNK01 to have a positive impact on all three proteins suggests that it could have clinical utility for numerous neurodegenerative diseases well beyond just Alzheimer's and Parkinson's. In addition, based on the recent publication by Guo, et al.1, which examined over 50,000 adults from the UK Biobank and found that GFAP, NfL, GDF15 and LTBP2 were consistently associated most with "incident all-cause dementia", biobank specimens from the Phase 1 trial were reassessed to explore the effect of SNK01 on each of these biomarkers."
Dr. Song further added, "In our dose escalation trial where the majority of the patients received suboptimal dosing and only four total treatments, we saw SNK01 was still able to reduce levels of all four biomarkers in at least 30% of all patients, suggesting that this could one day be potentially used as a safe preventative treatment for high-risk asymptomatic patients with elevated biomarkers especially with a higher dose. We are very impressed with the safety of SNK01 and ease of administration and its ability to cross the blood brain barrier. As more biomarker and clinical data emerge, we believe the potential applications of SNK01 will only increase."
Presentation Highlights:
SNK01 was shown to phagocytose and ingest amyloid and alpha-synuclein levels in vitro.
SNK01 was found to produce immunoregulatory cytokines in vitro.
SNK01 was found to reduce autoreactive T cells in vitro.
SNK01, given via a simple IV administration, appears to cross the blood brain barrier to improve AB42/40, Tau, and alpha-synuclein protein levels in CSF.
Despite a median MMSE score of 14, and 70% of patients treated at relatively low doses of SNK01, at one-week post-treatment (week 11):
50-70% of all enrolled patients in the trial had either stable or improved CDR-SB, ADAS-Cog and/or MMSE scores including one patient whose MMSE score improved from 14 to 23.
90% had either stable or improved ADCOMS scores.
60% of patients had improvements in GFAP and 30% of patients had improvements in NfL, GDF15, and LTBP2 after only four doses.
SNK01 appears safe and well tolerated, with no treatment-related adverse events observed; and the data suggest SNK01 may have potential clinical activity in AD. A larger Phase 2 placebo-controlled AD trial with a higher dosing and longer duration will begin to enroll in Q2 2024.
Rationale for use of SNK01 in Parkinson's was discussed along with the clinical trial plan to initiate a Phase 1 PD trial in 2H 2024.
A copy of the presentation is available on the Scientific Publications page of the Company's website at https://nkgenbiotech.com/.
1Guo Y et al. Plasma proteomic profiles predict future dementia in healthy adults. Nature Aging. 2024;4:247-260. https://doi.org/10.1038/s43587-023-00565-0.
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3 days ago
Huge news just out
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
Abstract Number: e14515
Session Type: Publication Only
Session Title: Developmental Therapeutics - Immunotherapy
A copy of the ePublication will be available on the Scientific Publications page of the Company's website at https://nkgenbiotech.com/.
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6 days ago
SANTA ANA, Calif., April 11, 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 cell therapeutics, today announced that it has closed $5 million in second lien convertible loan funding with a term of 30 months, augmenting approximately $4.75 in gross cash proceeds from prior 2024 funding to date. Outstanding or issuable securities that may deliver additional cash to the company over time, or on large share and volume moves, after their pending issue and/or registration, include over two million forward purchase shares and our expectation of over ten million warrants with a cash strike price set, or expected to be reset, at $2.00 per share.
"This $5 million in funding is a statement of confidence and support for NKGen, our team, and our story in a challenging market. This provides breathing room for us to execute our plans, continue to pursue larger funding opportunities with both financial and strategic investors, and capitalize on our outstanding structured securities upon registration of the underlying shares. It will help fund our clinical trials and operations, filing of our annual report on Form 10-K, and filing of an amended registration statement on Form S-1 soon thereafter. This will help us to achieve additional value-creating milestones across both our neurodegenerative and oncology clinical programs and repay certain bridge funding liabilities," said Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech.
Dr. Song continued, "We are intently focused on our upcoming Phase 2 Alzheimer's clinical trial and recently submitted an IND for Parkinson's disease while streamlining our resources for maximum efficiency. Accordingly, we have successfully reduced our monthly burn rate for operations and clinical trials by almost 50%. In addition, we have several catalysts expected this year including data readouts (both safety and cognitive) for the Phase 1 portion of our moderate Alzheimer's trial and the initiation of Phase 2."
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1 week ago
After a 17-year hiatus in drug approvals for neurodegeneration, disease-modifying drugs for AD have finally broken the ice. With Lecanemab’s clinically proven 30% reduction in cognitive decline receiving the green light from the FDA & PMDA and Eli Lilly’s Donanemab hot on their heels for approval, 58 new trials entering the pipeline this year, and the alpha-synuclein self-seeding assay changing the game for PD drug development.
The 12th Alzheimer’s & Parkinson’s Drug Development Summit is indisputably the ultimate industry-focused meeting dedicated to sharing the hottest unpublished AD & PD research from senior biopharma KOLs you won’t hear anywhere else, with deep-dive content all the way from early discovery through to late phase trials and approvals.
This April, join 150+ senior industry leaders across discovery, preclinical, biomarker, translational, clinical, and commercial this year from Eli Lilly, Biogen, Eisai, Abbvie, Merck, Michael J. Fox Foundation, Acumen, Vigil Neuroscience, and many more….
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NKGen Biotech Announces Upcoming Presentation on SNK01 NK Cell Therapy in Neurodegenerative Disease at the 12th Annual Alzheimer's & Parkinson's Drug Development Summit
Mentioned: NKGN
GlobeNewswireApril 18, 2024
SANTA ANA, Calif., April 18, 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 around its NK cell therapy in neurodegenerative disease, review its preclinical data in Parkinson's disease, and highlight clinical safety and efficacy data from the Company's recently completed Phase 1 clinical trial of SNK01, autologous natural killer cell therapy, in Alzheimer's disease at the 12th Annual Alzheimer's & Parkinson's Drug Development Summit to be held in Boston, MA, from April 23-25, 2024.
Presentation Details:
Title: Evaluating Adoptive Cellular Immunotherapy for Neurodegeneration with Autologous SNK01
Conference Track: Translational -- Harnessing Cell Therapy & Senescence to Reduce Alzheimer's Pathology in Preclinical Research
Date and Time: Thursday, April 25, 2024, 2:00 pm ET
Dr. Song's presentation will detail how enhanced natural killer cells can maximize the body's ability to destroy diseased and abnormal cells and provide a review of NK cell therapy as an alternative treatment modality to resolve neurodegeneration by harnessing the body's natural immune system, including a discussion on the scientific rationale behind the use of NK cell therapy for the treatment of Parkinson's disease. Dr. Song will also present clinical safety and efficacy data from the Company's recently completed Phase 1 clinical trial evaluating autologous SNK01 NK cell therapy in patients with Alzheimer's disease (NCT04678453).
A copy of the presentation will be available on the Scientific Publications page of the Company's website at https://nkgenbiotech.com/ once the presentation has concluded. Previously disclosed Phase 1 data on the positive effects of SNK01 on amyloid, tau and neuroinflammation biomarkers, which may not be included in this conference presentation, can also be found on the Scientific Publications page.