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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.
Monster running higher
Trial result for Alzheimer and Pakinson and cancer tumor coming out
This is billion dollar stock
Great result for many trials keep on coming
CEO has planned systematic trial readout in a row
Another huge P2 interim result for Alzheimer is due in June as well
Pps will keep on going up to fair market valuation soon
Another catalyst in May
Huge interim result of P1 trial for cancer tumor
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/.
evry time down down
Going for $2 today and $3 tmrw and $5 on Thursday
So much undervalued
Super Volcano Explosion !!
Do not forget this was trading $3-$4 a month ago
Thus presentation is biggest annual meeting for Alzheimer and Pakinson
SAVA. Alzheimer stock trading at $880 mil mktcap now
What will happen here upon astounding data presentation of Alzheimer and Pakinson on Thursday
This Pps is a gift
1000% explosion coming this week
This is what happens when the float is locked up by big boys
This bio co is worth more than $200 mil with promising P1 result of Alzheimer
150 big pharmaceutical international companies will line up to make a deal after astounding data presentation this Thursday
Insiders holds majority shares here
8 mil float was locked up now
Shares Outstanding 5 22.81M
Implied Shares Outstanding 6 22.39M
Float 8.05M
% Held by Insiders 1 57.71%
% Held by Institutions 1 17.11%
AH or Tmrw for sure
Big boys are accumulating now
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."
why do you not see an offering? no cash
Pps will keep going up as the low float being locked up
There is no offering risk here
My prediction Pps over $5 - $10 this week
This could explode over $10 this week
Only $250 mil mktcap at $10
Some group buying up the float before the data presentation
NKGN must be trading over $200 mil mktcap now
Just $30 mil mktcap now
I have no idea why the mktcap is at $25 mil right now
MM and shorts manipulation caused the pps suppression
I added huge at low Pps and will wait until P2 interim readout in June for 1000% profit
This Pps is a gift indeed
It is big thing to present at 12th annual Alzheimer and Parkinson’s summit so many big pharmaceutical companies attending
NJGN is presenting P1 complete results of Alzheimer and preclinical Pakinson data as well
This company is worth $1 billion mktcap
Good luck all
NKGN will be buyout candidate by many big pharmaceutical companies after the presentation at the summit next week
$5 billion - $10 billion buyout price
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….
Keep running in horrible red market
Something big news coming next week
So much undervalued at $25 mil mktcap
The fair value is $500 mil mktcap with P2 interim result coming in June and new indication of Pakinson as well
This could be $100 stock this year
Alzheimer P2 interim result due in June
1000% in 2 months
the market is well aware.
you have nothing science wise?
This was trading around $3-$4 a month ago
I think it will go higher upon Parkinson’s new data next week as well as Alzheimer’s
Billion dollars market
you are strawmanning all over the place.
Provide an argument please.
Im a bull too! Like CEOs optimism and improvement of cognitive. But the NKMax tie in is a stick in the soup.
1000% explosion coming sooner than I anticipated
Alzheimer and Parkinson’s market is more than $60 billion worldwide
Pls make the case on actual superiorerity via arguments. Claiming is easy.
NKGN is worth billion dollars based on P1 result of Alzheimer and preclinical result of Pakinson disease
Super explosion upon the data explosion next week
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.
You are dead wrong
NKGN became associate company now and IPO thru spac merger last year
Nothing to do with NK Max in Korea
Okay...they got me. Dumped shares on my ass lol. Good luck guys.
ST AR79 ty for info
https://www.chosun.com/english/market-money-en/2024/04/15/7IY6NRSMCZB77DGT2FLXZKG4UM/
Very possible to run 1000% or more. Especially while the float is so small and market cap sitting at $26M. Added more today, building a position.
Brief Summary
The goal of this clinical trial is to test SNK01 in participants with moderate Alzheimer's Disease. The main questions it aims to answer are:
1 - Is SNK01 safe and tolerable when administered every 3 weeks for up to 1 year as an intravenous infusion
2 - Can SNK01 administration improve cognitive assessment scores and biomarkers
Official Title:
A Phase I/IIa, Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of SNK01 in Participants With Moderate Alzheimer's Disease
Source:
https://clinicaltrials.gov/study/NCT06189963?cond=alzheimer%27s%20disease&intr=SNK01&rank=2
Huge P2 interim result for Alzheimer is coming soon
Billion dollar mktcap potential
1000% run coming
Is NKGN going to 0 ?? what is going on????
Did some DD. I'm in! Company is over 20 years in the making, a cell therapy company. Check out their website. Really interesting technology that they have already built!
NKGen Biotech’s innovative and unique NK cell immunotherapy, SNK, involves the infusion of one’s own activated NK cells into the body with the goal to improve immune system function, eliminate diseased or abnormal cells and prevent recurrence. SNK uses highly pure NK cells harvested from the patient’s blood, activated and infused back into the patient’s body.
SNK stands out from other available therapies because it is autologous, not genetically modified and has less chance of side effects than other therapies such as chimeric antigen receptor T cell (CAR-T) treatments.
SNK has a broad therapeutic potential within the areas of cancer, autoimmune and neurodegenerative diseases.
Autologous NK cell immunotherapy is treatment that provides immune enhancement using highly pure NK cells harvested from a patient’s body.
https://investorshub.advfn.com/uimage/uploads/2024/3/28/cupdmAutolgous-Manufacturing-Slide-8.3.23.png
Not sure why my pictures are a link now, they used to be just on here.
IND filing for our SNK01 program for Parkinson's Disease, and a preliminary data readout of our SNK02 allogeneic Phase I study in solid tumors, the first and only product candidate that does not require lymphodepletion, the latter two which are anticipated in the first quarter of 2024."
should we see some news in the next days for NKGN ???
If this can do what they say and gain FDA approval. This thing it going to like $200. At least 5 years out to get through phases.
Just started looking into this. Didn't do a deep dive yet. This was a red flag: *Nasdaq FSI: Deficient: Issuer Failed to Meet NASDAQ Continued Listing Requirements. Did management take care of this?
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