Alps Group Reports Nine-Patient NK Cell Safety Study Using Patent-Pending Protocol
Alps Group reported a peer-reviewed case series of nine patients receiving autologous NK cell infusions cultured via its proprietary, antibody-free protocol, demonstrating tolerability with no dose-dependent toxicities and cytotoxic activity against cancer cell models. The patent-pending in-house culture method (PI2025002484) enables cost-effective, large-scale NK cell production for future clinical trials.
1. Study Design and Patient Outcomes
Alps Group conducted a peer-reviewed case series with nine nonconsecutive patients who received autologous NK cell infusions produced by its in-house culture protocol at ALPS Medical Centre between 2023 and 2024. Patients were monitored for hematological parameters, liver function, hypersensitivity reactions, inflammatory markers and tumor markers, revealing clinical tolerability without dose-dependent toxicities and demonstrating NK cell cytotoxicity in in vitro cancer models.
2. Proprietary Culture Protocol and Patent
The study leveraged the company's antibody-free, patent-pending culture method (Malaysian patent application no. PI2025002484), which uses basic culture media and autologous plasma to produce highly pure NK cells. This approach reduces manufacturing barriers by enabling cost-effective, large-scale production of autologous immune cells, enhancing safety profile and potentially accelerating access to advanced immunotherapies.
3. Next Steps in Clinical Development
Preliminary data from the case series and supporting preclinical GLP studies provide a foundation for designing future clinical investigations in broader patient populations. Alps Group plans to expand its autologous NK cell pipeline, aiming to initiate larger trials that assess efficacy endpoints and further validate the safety and scalability of its proprietary protocol.