Alps Group Reports Positive Safety Data for Autologous NK Cell Therapy in Nine-Patient Case Series
核心洞察
Alps Group published peer-reviewed safety data from nine patients who received autologous Natural Killer cell infusions using the company's proprietary culture protocol.
The study demonstrated clinical tolerability with no significant adverse reactions, while NK cells showed cytotoxicity against cancer (搜索) cell models in laboratory testing.
The company's patent-pending antibody-free culture method enables cost-effective, large-scale production of highly pure NK cells using basic culture media and autologous plasma.
Alps Group Inc (搜索) announced positive safety and tolerability data from a nine-patient case series evaluating autologous Natural Killer (NK) cell therapy, marking a significant step forward for the company's immunotherapy pipeline. The peer-reviewed study, published in the February 2026 edition of SAGE Open Medical Case Reports, provides clinical evidence supporting the safety profile of NK cells produced using the company's proprietary culture protocol.
Clinical Study Design and Patient Population
The clinical case series study was registered with the National Medical Research Register, Ministry of Health Malaysia, under NMRR ID 25-00333-MUM. Data collection and analysis were conducted in accordance with the ethical principles of the Declaration of Helsinki and Malaysian Good Clinical Practice guidelines. The study involved nine nonconsecutive patients who received NK cell infusions at ALPS Medical Centre (搜索) between 2023 and 2024.
Patients were monitored pre- and post-infusion for hematological parameters, liver function, hypersensitivity reactions, inflammatory markers, and tumor markers to assess for potential NK cell-induced or dose-dependent toxic and adverse reactions. The comprehensive monitoring approach aimed to evaluate the clinical tolerability of autologous NK cells cultured using the company's proprietary protocol.
Safety and Efficacy Findings
The study provided evidence of clinical tolerability of the autologous NK cells, with no significant adverse reactions reported. Dr. Tham Seng Kong, Chief Executive Officer of Alps Group, stated, "Based on these preliminary observations, our in-house developed NK cells appear to be safe for use. The NK cells also exhibited cytotoxicity toward in vitro cultured and co-incubated cancer (搜索) cell models; however, this was assessed using pilot cultures rather than as part of batch-release testing."
The NK cells demonstrated cytotoxic activity against cancer (搜索) cell models in laboratory testing, though this assessment was conducted using pilot cultures rather than as part of formal batch-release testing protocols.
Proprietary Manufacturing Technology
A notable aspect of this case series is the company's patent-pending, antibody-free culture method (Malaysian patent application no. PI2025002484), which enables cost-effective, large-scale production of highly pure Natural Killer cells (搜索) using basic culture media and autologous plasma. This approach improves the safety profile of NK cells and lowers manufacturing barriers, potentially making advanced immunotherapy more accessible and efficient.
The antibody-free culture method represents a significant advancement in NK cell manufacturing, addressing key challenges in scalability and cost-effectiveness that have historically limited the broader application of NK cell therapies.
Future Clinical Development
Preliminary case series data supports the safety of this method, positioning Alps Group at the forefront of scalable, next-generation autologous immune cell therapy solutions. Together with preclinical GLP study data, the findings from this study are intended to support the design of future clinical investigations in a broader patient population.
The company plans to leverage these safety findings to advance its NK cell therapy pipeline and expand clinical testing to larger patient populations, building on the foundation established by this initial case series.
Company Background
Alps Group Inc (搜索) is the parent company of Alps Life Sciences Inc (搜索)., an integrated biotechnology platform integrating research and development, medical services, and wellness solutions of advanced therapies under one unified ecosystem aimed at improving healthcare outcomes globally. The company's mission is to create a fair healthcare ecosystem, making advanced predictive, preventive, and precision medicine accessible and affordable.