NKGen Biotech Publishes Phase 1 Interim Analysis Results of SNK02 Allogeneic NK Cell Therapy in Advanced Solid Tumors at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
NKGen Biotech has announced interim results from its Phase 1 clinical trial of SNK02, an allogeneic NK cell therapy for advanced solid tumors, at the 2024 ASCO Annual Meeting.
The trial showed that SNK02 was well-tolerated and demonstrated a stable disease response in 100% of patients completing 8 treatment cycles. The study involved five patients with refractory solid tumors, averaging four prior lines of therapy, and a median age of 64.
SNK02 did not require lymphodepletion before administration and exhibited some clinical activity as a monotherapy. Adverse events were mostly mild with one Grade 3 event resolving without intervention.
The company plans to continue studying SNK02 in combination with monoclonal antibodies and immune checkpoint inhibitors.
- SNK02 demonstrated a stable disease response in 100% of patients completing 8 cycles.
- SNK02 was well-tolerated with mostly mild adverse events.
- SNK02 does not require lymphodepletion, potentially improving synergy with other treatments.
- The therapy showed clinical activity against pretreated solid tumors.
- NKGen can produce hundreds of thousands of doses from a single donor.
- Only five patients were enrolled, limiting the data's robustness.
- One Grade 3 adverse event (increased fatigue) occurred.
- Development of auto-antibodies around cycle 5 linked to adverse events.
- There was one death in the study, though unrelated to SNK02.
Insights
The interim analysis of NKGen Biotech's SNK02 presents promising early results for a novel therapy in solid tumor treatment. The significant finding here is the possibility of administering an allogeneic NK cell therapy without lymphodepletion, a pre-treatment that often weakens the immune system. This could position SNK02 favorably in combination therapies, particularly with immune checkpoint inhibitors. However, it's important to note that the sample size of five patients is very small, limiting the strength of these conclusions.
In clinical trials, stable disease in 100% of patients completing the treatment cycles is a positive indicator, yet more comprehensive studies with larger cohorts are necessary to verify efficacy and safety. The observation of auto-antibodies aligning with adverse events also requires further investigation to understand long-term implications. Investors should stay attuned to subsequent trial phases and larger studies that could substantiate these initial findings.
From a financial perspective, NKGen's announcement could bolster investor confidence and potentially positively impact stock prices in the short term. The mention of scalability with their cryopreservation process is particularly relevant. Producing large quantities of NK cell therapies from a single donor implies potential for substantial cost-efficiencies and broad-reaching treatment capabilities. Yet, early-phase clinical trials are inherently uncertain and scaling from promising Phase 1 results to market approval involves significant risk and capital investment.
Investors should consider the company's financial health and capacity to sustain through the lengthy and expensive drug development process. The ultimate profitability will heavily rely on the successful completion of later phase trials, regulatory approvals and market adoption. Therefore, while the current results are encouraging, cautious optimism is advised.
SNK02 has the potential to be a first-in-class cryopreserved allogeneic NK cell therapy for solid tumors that does not require lymphodepletion before administration, which may lead to better overall synergy in future combination regimens with immune checkpoint inhibitors.
In this Phase 1 trial, the best objective response of stable disease was demonstrated in
SNK02 was well tolerated as a monotherapy and appears to have some clinical activity against pretreated solid tumors despite the lack of lymphodepletion.
SANTA ANA, Calif., May 23, 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 an online publication, titled “Interim Analysis of a Phase I Study using Cryopreserved Non-genetically Modified Allogeneic Natural Killer Cells With Enhanced Cytotoxicity (SNK02) in Patients with Advanced Solid Tumors without Lymphodepletion” at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting to be held virtually and at the McCormick Place Convention Center in Chicago, Illinois from May 31–June 4, 2024.
This Phase 1 clinical trial is a multi-center, open-label study evaluating the safety and tolerability of SNK02 in participants with pathologically confirmed solid tumors refractory to standard of care therapy. The study drug, SNK02, is a first-in-kind, cryopreserved allogeneic non-genetically modified NK cell product with significant anti-tumor cytotoxicity and over
“Interim data from our Phase 1 clinical study utilizing our second NK cell therapy product, SNK02, demonstrated that the treatment was well-tolerated as a monotherapy in patients with solid tumors refractory to standard of care therapy,” said Paul Y. Song, MD, Chairman and CEO of NKGen. “We are particularly excited because SNK02 has the potential to be a first-in-class cryopreserved allogeneic NK cell therapy for solid tumors that does not require lymphodepletion before administration, which may lead to better overall synergy in future combination regimens especially with immune checkpoint inhibitors where a robust T-cell response is needed. Using our proprietary allogeneic manufacturing and cryopreservation processes, we are capable of producing hundreds of thousands of potential doses of enhanced NK cell therapies from materials collected from a single donor. Thus, our potential to treat a significant number of cancer patients with SNK02 is remarkably high. We are pleased to see such promising Phase 1 trial results for both of our unique cell therapy candidates: autologous SNK01 for neurodegenerative disease and allogeneic SNK02 for cancer.”
For additional information on the SNK02 clinical trial, please visit https://www.clinicaltrials.gov/ using the identifier NCT05990920.
Highlights from the online publication include:
- Five patients with advanced refractory solid tumors were enrolled in the trial.
- Patients had received an average of 4 lines of prior therapy.
- Median age was 64 (range 44 – 71) and 3 were male.
- The subtypes were 1 leiomyosarcoma, 1 angiosarcoma, 1 endometrial adenocarcinoma, 1 undifferentiated pleomorphic sarcoma, and 1 colorectal adenocarcinoma.
- Four of five patients completed 8 cycles of SNK02. The best objective response of stable disease (tumor stopped growing) was demonstrated in
100% of patients that completed the 8 cycles. - Out of the 36 doses administered through Cycle 8, there were 17 Grade 1, 3 Grade 2, and 1 Grade 3 adverse events (AEs) related to investigational product (IP). The Grade 3 AE of increased fatigue resolved after 1 day with no intervention required.
- There was 1 death on study, which was deemed unrelated to the IP.
- Auto-antibodies appeared to develop around cycle 5 and appeared to correlate with AEs.
- SNK02 was well tolerated as a monotherapy and appears to have some clinical activity against pretreated solid tumors despite the lack of lymphodepletion. SNK02 will continue to be studied as a monotherapy and in potential combination treatment regimens with monoclonal antibodies and immune checkpoint inhibitors.
A copy of the ePublication will be available on the Scientific Publications page of the Company’s website at https://nkgenbiotech.com/.
About SNK02
SNK02 is a novel cell-based, donor-derived ex vivo expanded allogeneic natural killer (“NK”) cell, immunotherapeutic drug candidate. NKGen Biotech, Inc. is developing SNK02 for the treatment of a broad range of cancers.
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 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 SNK01, including the expected timing of completing and announcing further results from its ongoing clinical studies; statements regarding the Company’s plans and expected timing for developing 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, MT (ASCP)
Vice President, Investor Relations and Corporate Communications
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
FAQ
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