NKGen Biotech Announces FDA Clearance of Investigational New Drug (IND) Application for SNK01 NK Cell Therapy in Parkinson’s Disease

Rhea-AI Summary

NKGen Biotech, Inc. (NKGN) received FDA clearance for its SNK01 NK cell therapy in Parkinson's disease, advancing its neurodegenerative disease program. The Phase 1/2a clinical trial is set to commence in 2H 2024, with SNK01 showing promising potential in addressing Parkinson's disease through enhanced cytotoxicity and activating receptor expression.

Positive

• FDA clearance for SNK01 NK cell therapy in Parkinson's disease, advancing NKGen's neurodegenerative disease program.
• Promising potential of SNK01 in addressing Parkinson's disease through enhanced cytotoxicity and activating receptor expression.

Negative

• None.

Medical Research Analyst

The FDA's clearance of NKGen Biotech's IND for SNK01 NK cell therapy is an essential step towards exploring new therapeutic avenues in Parkinson's disease (PD). From a scientific standpoint, the development leverages the potential of natural killer (NK) cells to modulate neuroinflammation. Neuroinflammation is increasingly recognized as a significant factor in the progression of neurodegenerative disorders, including PD and Alzheimer's. The fact that SNK01 is an autologous, nongenetically modified product could differentiate it from other genetically engineered therapies, potentially offering a more favorable safety profile. This differentiation might appeal to patients and clinicians wary of gene therapy's unknown long-term effects. As trials commence and data emerges, particularly around cytotoxicity and receptor expression, the scientific community will gain insights into how NK cells can be harnessed to treat neurodegenerative diseases. Investors should monitor patient recruitment and trial progression keenly, as delays or rapid advancements could signal future commercial prospects.

Biotech Financial Analyst

NKGen Biotech's move to initiate a Phase 1/2a trial for SNK01 in PD patients could be an inflection point for the stock. Given the market's demand for innovative PD treatments and the high unmet medical need, a successful trial could pave the way for significant future revenues. One should consider that the path from Phase 1/2a to market is long and fraught with risk. Investors should weigh the company's burn rate against its capital reserves to sustain lengthy and expensive clinical trials. Furthermore, the investor community should assess the company's past clinical trial outcomes, as suggested efficacy in Alzheimer's trials may bode well for PD research. However, efficacy in one does not guarantee success in the other, considering the differing pathologies of these diseases. Share price volatility is likely to increase around trial updates, so risk tolerance will be a key consideration for potential investors. The dual-focus on protein deposition and neuroinflammation might present broader therapeutic applications, potentially enhancing the company's valuation if the science proves solid.

Healthcare Industry Analyst

The FDA's approval to proceed with clinical trials for NKGen's SNK01 marks a pivotal moment in the biotech industry, particularly for firms targeting neurodegenerative diseases. The strategic decision to target both Alzheimer's and Parkinson's with a shared therapeutic approach could streamline development costs and speed up the research process. This tactic is relatively common in the industry, as leveraging similarities between diseases can optimize R&D investments. For the broader healthcare sector, success in this trial could signal a shift towards non-genetic modification approaches in cell therapy. Given the current industry trend towards personalized medicine, NKGen's focus on autologous therapies aligns with market direction. Global investors will likely evaluate this IND clearance as an indicator of the company's potential to capitalize on the significant PD market and possibly extend to other neurodegenerative diseases. Close attention to the company's research outcomes could serve as a bellwether for innovation in this segment.

NKGen advances its neurodegenerative disease program with FDA IND clearance for its Phase 1/2a SNK01 Clinical Trial in patients with Parkinson’s disease.

The Company expects to initiate a Phase 1 clinical trial in PD in 2H 2024.

SANTA ANA, Calif., April 29, 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 the U.S. Food and Drug Administration (“FDA”) has cleared the Company’s Investigational New Drug (“IND”) application for SNK01 NK cell therapy for the treatment of Parkinson’s disease (“PD”). SNK01 is an autologous, nongenetically modified NK cell product that has enhanced cytotoxicity and activating receptor expression, potentially addressing a novel approach to tackling Parkinson’s disease.

The FDA IND clearance enables NKGen to initiate a Phase 1/2a clinical trial evaluating the safety, tolerability, and exploratory efficacy of SNK01 in patients with PD. The trial is designed to enroll up to 30 patients (20 receiving SNK01 and 10 receiving placebo). NKGen expects to begin the trial, with the first patient dosed, in the second half of 2024.

“The IND clearance marks a significant milestone as we advance our pipeline of NK cell therapy in neurodegenerative diseases,” said Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen. “This is our second IND approval for SNK01 within the past several months and underscores our focused dedication towards developing safe and effective treatments that target both protein deposition and neuroinflammation for patients with neurodegenerative diseases such as Alzheimer’s and Parkinson’s. We are excited to start our first clinical trial in PD as there currently is a high unmet medical need in this indication.”

Dr. Song further commented, “Given the encouraging outcomes regarding the reduction in neuroinflammation observed in our Phase 1 Alzheimer’s trials, we are optimistic about the potential benefits that may emerge in our Parkinson’s trial. Although these two neurodegenerative diseases differ, both share a neuroinflammatory component, which has led to our hypothesis that SNK01 may be beneficial in both indications. While directly inhibiting neuroinflammation, whether as an independent approach or in conjunction with other interventions, may not address the etiology, it can potentially decrease the production of factors that contribute to neurotoxicity, thereby hopefully leading to clinical improvements.”

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

When will NKGen initiate the Phase 1 clinical trial in Parkinson's disease?

NKGen expects to begin the trial, with the first patient dosed, in the second half of 2024.

What is SNK01?

SNK01 is an autologous, nongenetically modified NK cell product that has enhanced cytotoxicity and activating receptor expression.

How many patients will be enrolled in the Phase 1/2a clinical trial for SNK01?

The trial is designed to enroll up to 30 patients (20 receiving SNK01 and 10 receiving placebo).