NKGEN BIOTECH, INC. SNK01, a cryopreserved, autologous enhanced natural killer cell therapy, delivered in highest dose to date, demonstrates preliminary clinical benefit without any drug-related adverse events.
Company advances SNK01 into Phase 2 in moderate Alzheimer’s disease; first patient enrolled in Phase 2 expected in Q2 2024.
NKGen’s initial “proof of concept” Phase 1 study was an open label, 3+3 dose escalation study which demonstrated that even after only four doses (1, 2, or 4 billion cells) given simple IV, that SNK01 was very safe and able to cross the blood brain barrier to reduce amyloid, tau, and alpha-synuclein proteins as well as neuroinflammation in a dose responsive manner. Despite only receiving four doses, 90% of patients (median MMSE score of 14) demonstrated improvement or maintained stable cognitive function as per Alzheimer's disease composite score (“ADCOMS”).
Based on this initial pilot experience, NKGen received
After careful review of the Phase 1 data by a majority independent Safety Review Committee, SNK01 has been cleared by an
“We are excited to announce another important clinical milestone in our mission to advance SNK01 as the first potential disease modifying treatment of its kind for patients with more advanced Alzheimer’s disease,” said
“I am encouraged by the continued promise of NKGen’s SNK01 NK cell therapy in a difficult to treat disease such as Alzheimer’s,” said Dr.
About SNK01
SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (“NK”) cell, immunotherapeutic drug candidate.
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
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:
Vice President, Investor Relations and Corporate Communications
949-396-6830
dchua@nkgenbiotech.com
External Contacts:
Managing Director
ccalabrese@lifesciadvisors.com
Managing Director
kgardner@lifesciadvisors.com
2024 GlobeNewswire, Inc., source
