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NKGen Biotech Presents Updated Phase 1 Data on SNK02 Allogeneic NK Cell Therapy for Solid Tumors at the 6th Annual Allogeneic Cell Therapies Summit 2024

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NKGen Biotech presented updated Phase 1 data on its allogeneic NK cell therapy, SNK02, at the 6th Annual Allogeneic Cell Therapies Summit 2024. The therapy avoids lymphodepletion, aiming to preserve immune function and reduce toxicity. In the trial, 6 patients with advanced solid tumors received weekly intravenous doses of SNK02. Four patients completed 8 cycles, with stable disease observed in all. The treatment was generally well-tolerated, with most adverse events being mild. One death occurred but was deemed unrelated to the therapy. Further studies will explore SNK02 in combination with other immunotherapies.

Positive
  • SNK02 therapy avoids lymphodepletion, reducing toxicity and preserving immune function.
  • In Phase 1 trial, stable disease was observed in all patients who completed 8 cycles.
  • SNK02 was well-tolerated with most adverse events being mild (Grade 1 or 2).
  • Therapy appears to have some clinical activity against pretreated solid tumors.
  • SNK02 has potential for combination with other immunotherapies.
Negative
  • Only 6 patients were enrolled in the Phase 1 trial, limiting the data's robustness.
  • There were 17 mild adverse events and 4 more severe adverse events (Grade 3).
  • Auto-antibodies developed around Cycle 5, correlating with adverse events.
  • One death occurred during the study, though it was deemed unrelated to SNK02.

NKGen Biotech's presentation of updated Phase 1 data on SNK02, a novel allogeneic NK cell therapy, reveals important findings for the treatment of advanced refractory solid tumors. The study's primary endpoint was safety and the results indicated that SNK02 is well-tolerated as a monotherapy. Notably, the therapy was administered without lymphodepletion, a process typically required to prepare patients for NK cell therapy. Avoiding lymphodepletion is significant because it reduces toxicity and helps preserve immune function, which is especially beneficial for patients undergoing multiple treatments.

One of the most compelling findings from the Phase 1 trial is that SNK02 was able to achieve stable disease in 100% of patients who completed the 8 cycles of treatment. This is particularly promising given that these patients had undergone an average of four prior lines of therapy without success. Additionally, the adverse events reported were mostly low-grade (Grade 1 and 2), with only one Grade 3 event that resolved quickly without intervention. This suggests that SNK02 may offer a safer alternative to existing therapies.

Moreover, the development of autoantibodies around Cycle 5 and the lack of correlation between KIR mismatch or HLA subtyping with adverse events or tumor response are noteworthy. These findings could be pivotal in tailoring future treatments and understanding patient responses to allogeneic NK cell therapies. In summary, while these early results are promising, further studies are necessary to fully understand the potential and efficacy of SNK02, particularly in combination with other treatments such as immune checkpoint inhibitors and monoclonal antibodies.

The updated Phase 1 data for SNK02 provided by NKGen Biotech are quite promising, especially considering the challenging nature of treating advanced refractory solid tumors. The noteworthy aspect here is the omission of lymphodepletion, a common pre-treatment step that can be quite taxing on a patient's immune system. Eliminating this step could potentially reduce treatment-related toxicities and preserve immune function, which is important for patients who have already undergone multiple prior therapies.

The trial results showed that SNK02 was able to halt tumor progression in all patients who completed the 8-cycle regimen. This outcome is significant, as these patients had few remaining treatment options. The ability of SNK02 to achieve stable disease in such a heavily pretreated population suggests that this NK cell therapy could be an important addition to the armamentarium against solid tumors.

Additionally, the safety profile of SNK02 is encouraging. With most adverse events being of low severity and only one Grade 3 event that resolved without intervention, SNK02 appears to be a well-tolerated option. The development of autoantibodies is a point of interest, as it may influence future dosing strategies or combination therapies. Overall, the data support the continued investigation of SNK02 both as a monotherapy and in combination with other immune-modulating agents.

SANTA ANA, Calif., June 12, 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 presented details on its novel allogeneic blood-derived NK cell therapy (“SNK02”) commercial manufacturing and cryopreservation process by Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen, entitled, “Protecting Patients by Removing Need for Lymphodepletion to Better Preserve Immune Function”. Dr. Song also provided an update on the Company’s initial Phase 1 results using SNK02 to treat patients with advanced refractory solid tumors.

Dr. Song’s presentation explored the potential benefits of eliminating pre-treatment lymphodepletion in patients undergoing SNK02 therapy, aiming to safeguard immune function and aid in recovery. Avoiding lymphodepletion before administering cancer treatment can provide many benefits including reduced toxicity, preservation of immune function and potentially enhancing treatment efficacy. The presentation also included a discussion on the results from the Company’s Phase 1 SNK02 clinical study in solid tumors previously disclosed in a publication at the 2024 American Society for Clinical Oncology annual meeting. Moreover, unpublished Phase 1 SNK02 data were also presented.

The Phase 1 clinical trial administered SNK02 intravenously (“IV”) weekly for a total of 8 weeks with a starting dose of 6 x 109 SNK02 cells in patients with advanced refractory solid tumors, without lymphodepletion. The primary endpoint was safety based on adverse events, vitals, laboratory tests and physical exams. Tolerability and maximum tolerated dose were also evaluated. SNK02 was found to be well tolerated as a monotherapy and appears to have some clinical activity against pretreated solid tumors despite the lack of lymphodepletion.

Dr. Song commented during the presentation, “As most of the focus of NK cell therapy has been for liquid tumors with lymphodepletion, we have always believed that lymphodepletion could be detrimental to patients with solid tumors especially those being treated with immune checkpoint inhibitors, monoclonal antibodies or bispecific therapies where a robust immune response is essential. We therefore set out to develop a commercial scale manufacturing and cryopreservation process which could yield greater than 100,00 doses of SNK02 (cryopreserved enhanced activated allogeneic NK cells) with the idea that large doses could be delivered without lymphodepletion to potentially overcome any host versus graft reaction. We are pleased to show that, despite developing autoantibodies to sustained repeated dosing of our allogeneic product, SNK02 was safe and treatment appeared to stop the progression of several heavily pretreated solid tumors as a monotherapy. We are excited to further explore the efficacy of SNK02 in combination with immune checkpoint inhibitors and antibodies against solid tumors.”

Presentation Highlights:

  • In the Phase 1 SNK02 clinical trial, 6 patients, with advanced refractory solid tumors and an average of 4 prior lines of therapy, were enrolled. The median age was 64 years old (range, 44–71), and 4 were male.
  • The cancer subtypes included 2 colorectal cancers, 1 leiomyosarcoma, 1 angiosarcoma, 1 endometrial adenocarcinoma, and 1 undifferentiated pleomorphic sarcoma.
  • Four of six 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.
  • One patient received 18 consecutive weekly doses and another patient received 12 consecutive weekly doses.
  • 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.
  • There did not appear to be any correlation with KIR mismatch or HLA subtyping with AEs or tumor response.
  • 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 presentation is available on the Scientific Publications page of the Company’s website at https://nkgenbiotech.com/. Previously disclosed Phase 1 data on the positive effects of SNK02 on advanced solid tumors, which may not be included in this conference presentation, can also be found on the Scientific Publications page.

About SNK02
SNK02 is a novel cell-based, donor-derived ex vivo expanded allogeneic 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 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, 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

What is SNK02?

SNK02 is an allogeneic NK cell therapy developed by NKGen Biotech for treating solid tumors.

What were the results of the Phase 1 trial for SNK02?

The Phase 1 trial showed that SNK02 was well-tolerated and induced stable disease in all patients who completed 8 cycles.

Were there any adverse events in the SNK02 Phase 1 trial?

Yes, there were 17 mild adverse events and 4 more severe adverse events, including one Grade 3 event which resolved without intervention.

Did patients develop any resistance to SNK02 during the Phase 1 trial?

Auto-antibodies appeared to develop around Cycle 5, correlating with some adverse events.

What is the significance of avoiding lymphodepletion in SNK02 therapy?

Avoiding lymphodepletion reduces toxicity, preserves immune function, and potentially enhances treatment efficacy.

NKGen Biotech, Inc.

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