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NKGen Biotech’s SNK01 NK Cell Therapy Cleared to Start Phase 2 Clinical Trial in Alzheimer’s Disease

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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.

Positive
  • SNK01 advanced to Phase 2 clinical trials for moderate Alzheimer's disease.
  • Phase 1 trial showed no drug-related adverse events.
  • 90% of patients in Phase 1 showed cognitive improvement or stability.
  • Phase 2 trial will involve 30 patients, providing robust data.
  • SNK01 demonstrated the ability to cross the blood-brain barrier and reduce amyloid, tau, and alpha-synuclein proteins.
Negative
  • The Phase 2 trial will not start until Q2 2024, delaying potential market entry.
  • High dosage and long duration of treatment may pose challenges in real-world application.

NKGen Biotech’s announcement of progressing SNK01 to Phase 2 clinical trials in Alzheimer’s disease is a significant development. The transition to Phase 2 indicates that the therapy has met certain safety benchmarks in Phase 1 and is now poised for a more rigorous evaluation of its efficacy.

Understanding the Science: SNK01 is an autologous NK cell therapy, which means the therapy uses the patient’s own cells, minimizing the risk of immune rejection. Autologous therapies often represent a cutting-edge treatment approach, particularly for complex conditions like Alzheimer’s, where traditional treatments have shown limited success.

Clinical Significance: The preliminary data suggesting that SNK01 can reduce key Alzheimer’s biomarkers like amyloid, tau and alpha-synuclein is noteworthy. These proteins are heavily implicated in the pathology of Alzheimer’s and any therapy showing potential to reduce their presence could alter the treatment landscape significantly.

In Phase 1, no drug-related adverse effects were observed, which is encouraging for investors. The escalation to a dose of 6 billion cells and a full-year treatment regimen in Phase 2 will provide a more comprehensive understanding of the therapy’s impact on cognitive function, daily living activities and overall quality of life. The randomized, double-blind design of the Phase 2 trial, involving 30 patients, is a robust approach that will provide critical data on both efficacy and safety.

Market Implications: Alzheimer’s disease represents a vast market with immense unmet needs. A successful Phase 2 trial could not only position NKGen as a frontrunner in Alzheimer’s therapeutics but also create substantial market opportunities. If SNK01 continues to demonstrate safety and efficacy, it could attract considerable attention from larger biopharma companies interested in partnership or acquisition opportunities.

NKGen's progression of SNK01 into Phase 2 trials has several financial implications. Firstly, the approval to move forward without any drug-related adverse events in Phase 1 can be seen as a positive signal to investors, suggesting that safety concerns might not be a significant barrier moving forward.

Cost Implications: The costs associated with Phase 2 clinical trials are substantial, typically ranging from $7 million to $20 million depending on various factors such as patient recruitment and trial duration. Investors should consider NKGen’s current financial health and its ability to secure additional funding if needed. Positive interim results in Phase 2 could also unlock new capital through partnerships or secondary offerings.

Market Positioning: Alzheimer’s therapeutics is a highly competitive and lucrative market. The fact that SNK01 has shown preliminary clinical benefits without adverse events positions NKGen favorably against competitors. If successful, the commercialization of SNK01 could drive substantial revenue. Given that the Alzheimer's drug market is projected to reach $13 billion by 2030, even capturing a small market share could yield significant returns.

Risk Factors: Despite the positives, the transition to Phase 2 brings new risks. The failure rate in Phase 2 trials is higher than in Phase 1 and any negative outcomes could impact NKGen’s stock price significantly. Furthermore, investors should be aware of the dilution risk if the company opts for more equity financing to fund the trial.

Overall, while the news is positive, investors must weigh the potential for high rewards against the inherent risks of clinical trials and the financial demands associated with them.

The move to Phase 2 clinical trials for SNK01 positions NKGen Biotech at a critical juncture in the Alzheimer’s therapeutics market. This sector is characterized by high unmet needs and limited effective treatment options, creating a lucrative opportunity for any successful new therapy.

Competitive Landscape: Alzheimer’s disease has been a challenging area for drug development, with many high-profile failures. The fact that SNK01 has shown no adverse effects and potential cognitive benefits positions it uniquely within this competitive landscape. Other companies like Biogen and Eli Lilly have also pursued various therapeutic approaches, but NKGen’s use of autologous NK cells differentiates its methodology, potentially providing a unique competitive edge.

Market Dynamics: With an aging global population, the number of Alzheimer’s patients is expected to rise, increasing the demand for effective treatments. Successful Phase 2 results could catalyze interest not only from investors but also from healthcare providers looking for new treatment modalities. This could lead to increased market penetration and adoption rates post-approval.

Investor Sentiment: The narrative around innovative Alzheimer’s treatments is compelling and can drive investor interest. Positive developments in this field often generate significant media attention and can lead to stock price appreciation. Investors might also expect potential strategic partnerships or acquisitions if SNK01 shows continued promise.

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.”

About SNK01

SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (“NK”) cell, immunotherapeutic drug candidate. NKGen Biotech, Inc. is developing SNK01 for the treatment of neurodegenerative disorders and a broad range of cancers.

About NKGen Biotech

NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK NK cell therapeutics. NKGen is headquartered in Santa Ana, California, USA. For more information, please visit www.nkgenbiotech.com.

Forward-Looking Statements

Statements contained in this press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “could”, “continue”, “expect”, “estimate”, “may”, “plan”, “outlook”, “future” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are subject to risks and uncertainties, many of which are outside of the Company’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company’s plans and expected timing for developing SNK01, including the expected timing of completing and announcing further results from its ongoing clinical studies; and the Company’s expected timing for developing its product candidates and potential benefits of its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: the Company’s ability to execute its plans and strategies; risks related to performing clinical studies; the risk that initial and interim results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical studies and the reporting of data therefrom; the risk that studies will not be completed as planned; the risk that the abstract will not be published as planned including delays in timing, format, or accessibility; and NKGen’s ability to raise additional funding to complete the development of its product candidates. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in the Company’s filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission’s website at www.sec.gov and on the Company’s website under the subheading “Investors—Financial and Filings”. Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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

External Contacts:
Chris Calabrese
Managing Director
LifeSci Advisors, LLC
ccalabrese@lifesciadvisors.com

Kevin Gardner
Managing Director
LifeSci Advisors, LLC
kgardner@lifesciadvisors.com


FAQ

What is NKGen Biotech’s new development for Alzheimer's disease?

NKGen Biotech's SNK01, an enhanced NK cell therapy, has been cleared to enter Phase 2 clinical trials for moderate Alzheimer's disease.

When will NKGen Biotech start its Phase 2 clinical trial for SNK01?

The Phase 2 clinical trial for SNK01 is expected to begin in Q2 2024.

How many patients will participate in the Phase 2 trial of SNK01?

The Phase 2 trial will involve 30 patients, with 20 receiving SNK01 and 10 receiving a placebo.

What were the results of the Phase 1 trial for SNK01?

The Phase 1 trial for SNK01 showed no drug-related adverse events and 90% of patients showed cognitive improvement or stability.

What is the significance of SNK01 crossing the blood-brain barrier?

SNK01's ability to cross the blood-brain barrier is significant as it can potentially reduce amyloid, tau, and alpha-synuclein proteins, which are associated with Alzheimer's disease.

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