NKGen Biotech gears up for Parkinson's disease trial after FDA approval

SANTA ANA, Calif. – NKGen Biotech, Inc. (Nasdaq: NKGN), a clinical-stage biotechnology company, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the investigational new drug development of SNK01 ( IND) application for a natural killer (NK) cell therapy designed to treat Parkinson's disease (PD).

The FDA approval paves the way for the company to initiate a Phase 1/2a clinical trial, which is expected to begin in the second half of 2024.

This trial will explore the safety, tolerability and preliminary efficacy of SNK01 in patients with PD. The study will have a maximum of 30 participants, with 20 patients receiving the investigational treatment and 10 patients receiving placebo.

NKGen Chairman and CEO Paul Y. Song, Ph.D., expressed the importance of this development and noted that there is an urgent need for new treatments in the field of neurodegenerative diseases, especially diseases such as Parkinson's disease and Alzheimer's disease. Dr. Song highlighted promising results from an early Alzheimer's Phase 1 trial, in which SNK01 showed reduced nerve inflammation, reinforcing the company's optimism about its potential to treat Parkinson's disease.

SNK01 is an autologous, non-genetically modified NK cell product with enhanced cytotoxicity and activating receptor performance. It represents a new strategy to combat Parkinson's disease by potentially addressing protein deposits and nerve inflammation, which are common pathological features of various neurodegenerative diseases.

NKGen Biotech develops cell therapies for diseases with high unmet medical need. The company's focus is on autologous, allogeneic and CAR-NK NK cell therapies. Headquartered in Santa Ana, California, NKGen continues to contribute to the ongoing development of biotechnological treatments for complex diseases.

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The announcement of the FDA IND approval is based on a press release from NKGen Biotech, Inc.

Investment Professional Insights

Given NKGen Biotech's recent FDA IND approval for its SNK01 therapy, investors are paying close attention to the company's financials and market performance. According to live data from InvestingPro, NKGen Biotech, Inc. (NASDAQ:NKGN) has a market capitalization of approximately $36.72 million, reflecting the company’s current market valuation.

InvestingPro Tips indicates that NKGen has a heavy operating debt load and is burning through cash rapidly, which are important factors for investors to consider. These aspects are especially important as the company begins expensive clinical trials of its Parkinson's disease treatment.

In addition, the company's stock rose significantly last week, with a total stock price return of 9.52%. The recent rise may be in response to positive news about the FDA approval, but it's worth noting that the stock has fallen significantly in the last year, with a one-year total price return of -84.18%.

Investors should be aware that NKGen doesn't pay dividends, which means returns must come from capital gains. The stock's trading price is often volatile, which can create opportunities and risks for traders and investors.

For those interested in taking a closer look at NKGen's financials and stock performance, there are additional InvestingPro Tips available that provide a more comprehensive analysis of the company's prospects.To explore these further, visit https://www.investing.com/pro/NKGN and remember to use the coupon code PRONEWS24 Annual or biennial Pro and Pro+ subscriptions receive an additional 10% discount. InvestingPro also lists 9 tips that can help you understand NKGen's financial health and market behavior in more detail.

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