NKGen Biotech Announces Administration of First Dose of Troculeucel to Frontotemporal Dementia Patient Under FDA-Cleared Compassionate Use Program

February 21, 2025 at 08:00 AM EST

SANTA ANA, Calif., Feb. 21, 2025 (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 and allogeneic natural killer (“NK”) cell therapeutics, today announced the administration of troculeucel, an expanded autologous NK cell therapy, in an FTD patient under a single compassionate use, Investigational New Drug (“IND”) cleared by the U.S. Food and Drug Administration (“FDA”).

It is estimated that about 60,000 people in the U.S. are currently living with FTD. Up to 40% of FTD cases have a genetic component and the patient receiving troculeucel is known to carry the C9orf72 gene mutation. Currently, there is no cure for FTD and, unfortunately, no current treatments are available that slow or stop disease progression.

NKGen has begun to explore the potential therapeutic role of troculeucel for the treatment of FTD in collaboration with Mario Mendez, M.D., Ph.D., Director of the Behavioral Neurology Program at the David Geffen School of Medicine at UCLA and Jessica Rexach, M.D., Ph.D., Director of the Rexach Lab at UCLA Department of Neurology. This single, FDA-cleared, IND compassionate use will be the initial step towards a future full IND application as the dosing of the first FTD patient is part of NKGen’s ongoing effort to explore the potential of its NK cell therapy for those suffering from neurodegenerative diseases, especially when existing therapies have not been effective.

“While most of our experience has been in treating patients with Alzheimer’s and Parkinson’s, we know that there is a common theme of neuroinflammation and damage in numerous neurodegenerative diseases,” said Paul Y. Song, M.D., Executive Chairman and Chief Executive Officer of NKGen. “We have previously shown that troculeucel can cross the blood brain barrier to improve levels of amyloid, α-synuclein, and tau proteins in CSF in our treated Alzheimer’s patients as well as reduce neuroinflammation as shown by a reduction in glial fibrillary acidic protein (“GFAP”). Of note is that GFAP and tau are both consistently elevated in patients with FTD and we believe this supports the rationale of trying troculeucel in such patients. We are excited with the potential outcomes using our NK cell therapy in a difficult-to-treat patient population.”

“The potential to influence brain disease by modulating peripheral immune components represents a truly pivotal frontier in our field,” said Dr. Rexach, M.D., Ph.D., Director of the Rexach Lab at UCLA Department of Neurology. “It’s imperative that we bring these opportunities forward to address additional devastating, currently incurable neurodegenerative disorders, like frontotemporal dementia, in addition to Alzheimer’s disease. By incorporating key biomarkers of both neuroinflammation and neurodegeneration, this work is designed to yield impact and achieve critical progress. This effort will ultimately inform effective strategies for immune cell modulation in FTD, paving the way for clinically effective strategies. This work is not only incredibly important, but also exceptionally timely.”

“FTD and its related disorders are devastating for patients and families. As a clinician caring for them, it is difficult to tell them that there are no disease-modifying treatments,” said Dr. Mendez, M.D., Ph.D., Director of the Behavioral Neurology Program at the David Geffen School of Medicine at UCLA. “I’m impressed with the preliminary troculeucel clinical and biomarker data in Alzheimer’s patients and believe its ability to reduce both tau proteins and neuroinflammation in the cerebral spinal fluid (“CSF”) might be beneficial in FTD and related disorders. I look forward to exploring this further in hopes of making a real difference in these disorders.”

The patient will be routinely assessed independently by Dr. Mendez at UCLA while receiving troculeucel infusions at the Sarcoma Oncology Center under the guidance of Dr. Sant Chawla and Dr. Erlinda Gordon.

About Troculeucel
Troculeucel is a novel cell-based, patient specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate. NKGen is developing troculeucel for the treatment of neurodegenerative disorders and a broad range of cancers. Troculeucel is the International Nonproprietary Name (“INN”) for SNK01 assigned by the World Health Organization (“WHO”). The WHO INN approval of troculeucel establishes a universally recognized nonproprietary drug name for SNK01 and marks a significant step on NKGen’s journey toward bringing this therapy to market.

About NKGen Biotech
NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic 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 troculeucel and SNK02, 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, MLS (ASCP)
SVP, Corporate Affairs
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

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NKGen Biotech Announces Administration of First Dose of Troculeucel to Frontotemporal Dementia Patient Under FDA-Cleared Compassionate Use Program

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