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NKGen Biotech, Inc. (symbol: NKGN) is a progressive biotechnology company dedicated to developing cutting-edge cell therapies aimed at combating neurodegenerative and oncological diseases. The company’s central focus revolves around utilizing activated NK cells, which form a part of the human innate immune response system. These cells have the remarkable ability to selectively identify and eliminate abnormal or diseased cells.
NKGen Biotech’s innovative approach is anchored in a proprietary manufacturing and cryopreservation process that produces SuperNK™ (SNK) cells. These cells exhibit significantly enhanced activity compared to the original population of NK cells. Enhanced parameters include increased cytotoxicity, cytokine production, and activating receptor expression, based on detailed in vitro experiments conducted by NKMAX. One of the notable advantages of SNK cells is their ability to be produced in large quantities and preserved cryogenically without losing their high levels of cytotoxicity.
Recently, NKGen Biotech has achieved significant milestones with its SNK01 trial. Additional Phase 1 data point to clinical activity regarding cognitive function in patients with advanced Alzheimer’s disease, alongside previously disclosed positive effects on amyloid protein and neuroinflammation biomarkers. Dr. Jesse Carr, MD, Medical Director of Behavioral Research Specialists, LLC, has expressed optimism about the trial, highlighting the absence of treatment-related adverse events and noting apparent improvements in patients' cognitive function, daily living activities, and overall quality of life.
For investors and stakeholders, NKGen Biotech represents a beacon of innovation in the biotechnology sector, with its unique approach to developing cell therapies that could potentially redefine the treatment landscape for challenging diseases like Alzheimer’s and various cancers. The company’s robust pipeline, strategic partnerships, and ongoing clinical trials position it as a key player in advancing medical science and therapeutic solutions.
For the latest updates and detailed information, visit the NKGen Biotech website.
NKGen Biotech (Nasdaq: NKGN) has announced promising interim data from the Phase 1 cohort of its Phase 1/2a clinical trial for troculeucel, an autologous enhanced NK cell therapy for moderate Alzheimer's disease (AD). Two out of three patients treated with the highest dose (6 billion cells) showed improved CDR-SB cognitive scores, upgrading from moderate to mild AD after just three months.
The company has also dosed the first patient in the Phase 2 cohort, continuing with the 6 billion cell dose. The Phase 2 trial will evaluate troculeucel's efficacy in a randomized, double-blind, placebo-controlled study with 30 moderate AD patients. NKGen has activated four clinical sites across North America and expects to increase enrollment soon.
NKGen Biotech (Nasdaq: NKGN), a clinical-stage biotechnology company specializing in NK cell therapeutics, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024. Paul Y. Song, MD, Chairman and CEO of NKGen, will deliver a virtual presentation and engage in one-on-one meetings with investors.
Key points:
- The virtual presentation will be available on-demand starting September 9, 2024, at 7:00 AM Eastern Time
- Registered participants can submit questions after the presentation
- A webcast of the pre-recorded presentation will be accessible on NKGen's website
- The webcast replay will be available for 90 days following the presentation
This event provides an opportunity for NKGen to showcase its innovative NK cell therapeutics and engage with potential investors.
NKGen Biotech (Nasdaq: NKGN) has received a standard notice from Nasdaq on August 20, 2024, stating that the company is not in compliance with Nasdaq Listing Rule 5250(c)(1). This is due to the delayed filing of its Quarterly Report on Form 10-Q for the period ended June 30, 2024. The delay is partly attributed to recent changes in the company's independent registered public accounting firm and valuation firm.
NKGen has been given 60 calendar days, until October 21, 2024, to submit a plan to regain compliance. Nasdaq can grant an exception of up to 180 calendar days, until February 18, 2025. The notice has no immediate effect on the listing or trading of NKGen's common stock on the Nasdaq Global Market. The company is actively working to file the Form 10-Q promptly and regain compliance within the given timeframe.
NKGen Biotech presented new positive data on its SNK01 therapy for Alzheimer's disease at the 2024 AAIC. The study showed that SNK01, a cryopreserved autologous non-genetically modified NK cell product, can effectively reduce α-synuclein (α-syn) protein levels in the cerebrospinal fluid of Alzheimer's patients. This is significant as increased α-syn correlates with worse cognitive performance and is not targeted by current treatments.
Key findings include:
- 60% of patients showed decreased CSF α-syn levels
- 90% of patients demonstrated stable or improved cognitive function
- SNK01 also improved amyloid, tau, and neuroinflammatory markers
- The therapy was well-tolerated with no treatment-related adverse events
NKGen plans to expand investigation in a larger Phase II trial with higher doses and longer treatment duration.
NKGen Biotech (Nasdaq: NKGN) will present new biomarker data on its SNK01 therapy for Alzheimer's disease at the 2024 Alzheimer's Association International Conference. The poster presentation will showcase SNK01's ability to reduce α-synuclein in Alzheimer's patients, which is significant as α-synuclein correlates with worse cognitive function. The presentation, titled 'Subjects treated with expanded non-genetically modified autologous Natural Killer cells (SNK01) show improved changes in CSF α-synuclein and in cognitive function,' will be held on July 30, 2024. This data adds to previously disclosed Phase 1 results showing SNK01's positive effects on amyloid, tau, and neuroinflammation biomarkers in Alzheimer's patients.
NKGen Biotech (Nasdaq: NKGN) has appointed Dr. Marco Gottardis to its Board of Directors, effective July 11, 2024. Dr. Gottardis will serve on the company's Audit, Compensation, and Nominating and Corporate Governance Committees. He brings extensive experience in biopharmaceuticals and oncology research, having held senior positions at Replay Bio Holdings and Janssen Pharmaceuticals. Dr. Gottardis has a PhD in Human Oncology and has led strategies for novel research platforms and prostate cancer R&D portfolios.
NKGen's CEO, Dr. Paul Y. Song, expressed enthusiasm about Dr. Gottardis joining the board, highlighting his expertise in cell therapy research and development. This appointment is expected to strengthen NKGen's capabilities as they advance their NK cell therapy clinical programs in neurodegenerative diseases and cancer.
NKGen Biotech presented updated Phase 1 data on its allogeneic NK cell therapy, SNK02, at the 6th Annual Allogeneic Cell Therapies Summit 2024. The therapy avoids lymphodepletion, aiming to preserve immune function and reduce toxicity. In the trial, 6 patients with advanced solid tumors received weekly intravenous doses of SNK02. Four patients completed 8 cycles, with stable disease observed in all. The treatment was generally well-tolerated, with most adverse events being mild. One death occurred but was deemed unrelated to the therapy. Further studies will explore SNK02 in combination with other immunotherapies.
NKGen Biotech (Nasdaq: NKGN) announced that CEO Paul Y. Song, MD, will present updated Phase 1 data on their SNK02 allogeneic NK cell therapy at the 6th Annual Allogeneic Cell Therapies Summit, June 10-12, 2024, in Boston, MA. The presentation, scheduled for June 12, will highlight the company's cryopreserved allogeneic NK cell therapy platform and the initial Phase 1 results for advanced refractory solid tumors. Dr. Song will discuss the potential benefits of eliminating pre-treatment lymphodepletion, which may reduce toxicity and preserve immune function. Further, the presentation will explore unexpected findings from the SNK02 trial that suggest its use beyond cancer treatment. A copy of the presentation will be available on the company's website post-event.
NKGen Biotech has announced interim results from its Phase 1 clinical trial of SNK02, an allogeneic NK cell therapy for advanced solid tumors, at the 2024 ASCO Annual Meeting.
The trial showed that SNK02 was well-tolerated and demonstrated a stable disease response in 100% of patients completing 8 treatment cycles. The study involved five patients with refractory solid tumors, averaging four prior lines of therapy, and a median age of 64.
SNK02 did not require lymphodepletion before administration and exhibited some clinical activity as a monotherapy. Adverse events were mostly mild with one Grade 3 event resolving without intervention.
The company plans to continue studying SNK02 in combination with monoclonal antibodies and immune checkpoint inhibitors.
NKGen Biotech announced that its cryopreserved, enhanced natural killer cell therapy, SNK01, has been cleared to progress into Phase 2 clinical trials for moderate Alzheimer’s disease. The therapy showed clinical benefit and no drug-related adverse events in Phase 1. The Phase 2 trial will involve 30 patients, with 20 receiving SNK01 and 10 receiving a placebo, and will begin in Q2 2024. This trial aims to assess the therapy's efficacy and safety over a full year. Preliminary results are promising, with improvements in cognitive function and daily activities observed.
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