NKGen Biotech Reveals Phase 1 Results of SNK02 NK Cell Therapy in Advanced Tumors at 2024 ASCO Meeting

NKGen Biotech, Inc., a clinical-stage biotechnology company, has announced promising interim results from its Phase 1 trial of SNK02, a cryopreserved allogeneic NK cell therapy designed for solid tumors. SNK02 distinguishes itself by not requiring lymphodepletion prior to administration, which could enhance its synergistic potential when combined with immune checkpoint inhibitors.

In the Phase 1 trial, 100% of patients who completed the eight treatment cycles of SNK02 achieved stable disease as the best objective response. This suggests that SNK02 can halt tumor growth even in patients who had previously undergone multiple treatments. The trial enrolled five patients with advanced, refractory solid tumors, each having received an average of four prior therapies. The patients’ median age was 64, and the trial included three males and two females. The tumor types treated were leiomyosarcoma, angiosarcoma, endometrial adenocarcinoma, undifferentiated pleomorphic sarcoma, and colorectal adenocarcinoma.

SNK02 was administered intravenously once a week for eight weeks, starting with a dose of 6x10^9 cells. The therapy was well-tolerated with manageable adverse events, including 17 Grade 1 events, three Grade 2 events, and one Grade 3 event related to fatigue, which resolved without intervention. One patient died during the study, although this was deemed unrelated to the investigational product. Interestingly, auto-antibodies developed around cycle five, which appeared to correlate with adverse events.

The primary endpoint of the study was to assess the safety, with secondary endpoints including the tolerability and maximum tolerated dose of SNK02. The results showed that SNK02 was well-tolerated and exhibited clinical activity against solid tumors, despite the absence of lymphodepletion.

Dr. Paul Y. Song, Chairman and CEO of NKGen Biotech, highlighted the potential of SNK02 as a first-in-class therapy that could be administered without lymphodepletion, potentially improving the effectiveness of combination therapies, particularly those involving immune checkpoint inhibitors. This could be particularly beneficial in protocols requiring a strong T-cell response. Using NKGen’s proprietary manufacturing and cryopreservation techniques, hundreds of thousands of doses can be produced from a single donor, making the therapy scalable for widespread clinical use.

The interim results of this trial have been published online and will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Future studies will continue to evaluate SNK02 both as a standalone treatment and in combination with other therapeutic agents like monoclonal antibodies and immune checkpoint inhibitors.

NKGen Biotech is also developing another NK cell therapy, SNK01, for neurodegenerative diseases. The company is committed to advancing these innovative therapies to address unmet medical needs in various diseases, leveraging their extensive research and manufacturing capabilities.

The promising results from the Phase 1 trial of SNK02 offer hope for the development of effective new treatments for patients with refractory solid tumors, potentially transforming the therapeutic landscape for cancer care. As the trials progress, NKGen will continue to monitor and report on the effectiveness and safety of SNK02, aiming to bring this innovative therapy to market.