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

March 03, 2025 at 08:00 AM EST

SANTA ANA, Calif., March 03, 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 a stroke patient under a single compassionate use, Investigational New Drug (“IND”) cleared by the U.S. Food and Drug Administration (“FDA”).

Stroke is the second leading cause of death and long-term disability. It is accompanied by an increase in chronic neuroinflammation that can contribute to further subsequent neurological damage. Of note is that one fifth of stroke survivors go on to develop dementia after a stroke, with an 80% higher risk of developing dementia compared to matched controls.

In collaboration with Dimitri Sigounas, M.D., Associate Professor of Neurological Surgery and Amarendra K. Neppalli, M.D., Director of Transplant and Cellular Therapy at George Washington University (“GWU”) Medical Center, Washington, D.C., NKGen has begun to explore the potential therapeutic role of troculeucel in the post-stroke setting. This FDA-cleared single compassionate use IND will be the initial step towards a possible full IND application. Dosing the first stroke patient is part of NKGen’s continued efforts to explore the potential of its NK cell therapy for individuals suffering post-stroke and traumatic brain injury, especially as a means to reduce or prevent chronic neuroinflammation and damage, alongside NKGen’s positive ongoing work in Alzheimer’s and other neurodegenerative diseases.

The patient will receive troculeucel infusions and undergo regular independent assessments by Dr. Sigounas at GWU Medical Center.

“Neurofilament light chain (“NfL”) and glial fibrillary acidic protein (“GFAP”) are markers of brain injury which have been used to assess functional outcome in stroke patients. In our Alzheimer’s trials, we have found that troculeucel can cross the blood brain barrier to reduce cerebrospinal fluid levels of GFAP and NfL” said Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen. “We believe that troculeucel could potentially be a novel approach to reduce chronic neuroinflammation and the associated long-term sequelae in the post-stroke setting.”

“I am excited to explore whether enhanced NK cells can help reduce neuroinflammation in the post-stroke setting to help improve overall outcomes. If so, I believe this may be a very important first step in finding new ways to help stroke patients,” commented Dr. Sigounas.

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