Monday, April 29, 2024 8:09:07 AM
Mentioned: NKGN
GlobeNewswireApril 29, 2024
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."
Recent NKGN News
- Form 8-K - Current report • Edgar (US Regulatory) • 02/22/2024 09:01:29 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:19:39 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:16:19 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:14:43 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 01:11:45 AM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/14/2024 06:05:36 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/22/2024 11:12:43 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/08/2024 10:19:22 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/28/2023 09:14:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/27/2023 09:02:04 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/27/2023 09:01:25 PM
- Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend] • Edgar (US Regulatory) • 12/19/2023 06:41:42 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2023 09:39:00 PM
- NKGen Biotech Shares Rise 8% After FDA Clears IND Application for SNK01 • Dow Jones News • 10/24/2023 02:56:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/24/2023 12:05:14 PM
FEATURED Music Licensing, Inc. (OTC: SONG) Subsidiary Pro Music Rights Secures Final Judgment of $114,081.30 USD, Demonstrating Strength of Licensing Agreements • May 17, 2024 11:00 AM
Greenlite Ventures Inks Deal to Acquire No Limit Technology • GRNL • May 17, 2024 3:00 PM
VPR Brands (VPRB) Reports First Quarter 2024 Financial Results • VPRB • May 17, 2024 8:04 AM
ILUS Provides a First Quarter Filing Update • ILUS • May 16, 2024 11:26 AM
Cannabix Technologies and Omega Laboratories Inc. enter Strategic Partnership to Commercialize Marijuana Breathalyzer Technology • BLO • May 16, 2024 8:13 AM
Avant Technologies to Revolutionize Data Center Management with Proprietary AI Software Platform • AVAI • May 16, 2024 8:00 AM