Periodic Reporting for period 1 - Sub-NK (Subcutaneous delivery of theranostic cell-based therapies)
Reporting period: 2024-01-01 to 2025-06-30
Cancer immunotherapy has transformed cancer treatment, with natural killer (NK) cells showing particular promise due to their ability to selectively target and eliminate cancer cells. However, effective delivery of these therapeutic cells to tumor sites while maintaining their viability remains a critical challenge. Current intravenous administration approaches suffer from rapid systemic clearance, poor tumor penetration, and off-target effects, limiting NK cell therapy effectiveness especially in solid tumors.
This ERC Proof of Concept project addressed these delivery challenges by developing an innovative biomaterial platform for controlled, localized NK cell delivery. The primary objective was creating and validating a biocompatible hydrogel system that maintains NK cell viability while providing sustained, controlled release directly at tumor sites through subcutaneous administration. The research tackled the need for improved delivery systems in solid tumor treatment, where traditional systemic approaches show limited efficacy, while addressing both clinical needs for targeted therapy and practical considerations of treatment accessibility and patient comfort.
The platform technology has potential to advance cancer immunotherapy by overcoming delivery limitations that have hindered broader clinical application of NK cell therapies. Beyond immediate therapeutic applications, this establishes a foundation for next-generation cancer treatment approaches. Clinically, the technology could enable more effective solid tumor treatment, including breast cancer subtypes with significant unmet medical needs. The controlled delivery approach may improve therapeutic outcomes while reducing systemic side effects compared to conventional cell therapy administration.
The translational potential is evidenced by industry interest and patent protection, indicating relevance to real-world clinical challenges. This interdisciplinary convergence of materials science, immunology, and clinical translation demonstrates how such approaches can address complex healthcare challenges. The work contributes to precision medicine by developing tools for targeted therapeutic delivery, potentially improving patient outcomes while advancing understanding of effective cancer treatment strategies. The completed proof-of-concept establishes a foundation for future clinical development with clear regulatory and clinical pathways identified.
This ERC Proof of Concept project addressed these delivery challenges by developing an innovative biomaterial platform for controlled, localized NK cell delivery. The primary objective was creating and validating a biocompatible hydrogel system that maintains NK cell viability while providing sustained, controlled release directly at tumor sites through subcutaneous administration. The research tackled the need for improved delivery systems in solid tumor treatment, where traditional systemic approaches show limited efficacy, while addressing both clinical needs for targeted therapy and practical considerations of treatment accessibility and patient comfort.
The platform technology has potential to advance cancer immunotherapy by overcoming delivery limitations that have hindered broader clinical application of NK cell therapies. Beyond immediate therapeutic applications, this establishes a foundation for next-generation cancer treatment approaches. Clinically, the technology could enable more effective solid tumor treatment, including breast cancer subtypes with significant unmet medical needs. The controlled delivery approach may improve therapeutic outcomes while reducing systemic side effects compared to conventional cell therapy administration.
The translational potential is evidenced by industry interest and patent protection, indicating relevance to real-world clinical challenges. This interdisciplinary convergence of materials science, immunology, and clinical translation demonstrates how such approaches can address complex healthcare challenges. The work contributes to precision medicine by developing tools for targeted therapeutic delivery, potentially improving patient outcomes while advancing understanding of effective cancer treatment strategies. The completed proof-of-concept establishes a foundation for future clinical development with clear regulatory and clinical pathways identified.
Activities performed and main achievements: The research program optimized hydrogel formulations through extensive screening of polymer compositions to achieve sustained NK cell release. A major breakthrough was demonstrating NK cell viability exceeding five days without supplements, addressing a critical challenge in controlled cell delivery. Therapeutic studies confirmed that released NK cells retained their cancer-fighting capabilities, with the team strategically pivoting from multiple myeloma to HER2+ breast cancer models to enhance clinical relevance. Safety assessment in mouse models established dosing parameters for clinical translation and confirmed biocompatibility and biodegradability. Human skin explant studies provided clinically relevant data for subcutaneous administration. Biodistribution studies demonstrated NK cell activation and tumor penetration, with microscopic analysis confirming cellular internalization. Comparative studies validated advantages over intravenous delivery, while advanced bioluminescence imaging enabled real-time tumor monitoring.
Key technical achievements:
Biocompatible hydrogel platform for controlled NK cell release
Extended cell viability without external supplements
Preserved therapeutic efficacy post-release
Clinical translation-ready safety parameters
Advanced treatment monitoring protocols
Project outcomes
All work packages were completed with strategic enhancements to the original objectives. The project delivered a validated hydrogel platform, comprehensive preclinical safety and efficacy data, patent protection filed in 2025, demonstrated industry interest through licensing discussions, and a manuscript in preparation for publication by end of 2025.
The work successfully transitioned from proof-of-concept to a technology platform with established pathways for clinical development, regulatory submission, and therapeutic application, providing a foundation for advancing biomaterial-mediated immunotherapy approaches.
Key technical achievements:
Biocompatible hydrogel platform for controlled NK cell release
Extended cell viability without external supplements
Preserved therapeutic efficacy post-release
Clinical translation-ready safety parameters
Advanced treatment monitoring protocols
Project outcomes
All work packages were completed with strategic enhancements to the original objectives. The project delivered a validated hydrogel platform, comprehensive preclinical safety and efficacy data, patent protection filed in 2025, demonstrated industry interest through licensing discussions, and a manuscript in preparation for publication by end of 2025.
The work successfully transitioned from proof-of-concept to a technology platform with established pathways for clinical development, regulatory submission, and therapeutic application, providing a foundation for advancing biomaterial-mediated immunotherapy approaches.
The hydrogel platform tackles long-standing problems in cancer immunotherapy by solving how to deliver NK cells effectively to tumors. Current treatments rely on intravenous injections that don't target tumors well and cause unwanted side effects throughout the body. Our subcutaneous approach keeps therapeutic cells where they're needed most while making treatment easier for patients.
The commercial prospects look promising. A biotech company has already expressed interest in licensing the technology, and we've filed patent protection. This creates opportunities for job creation and economic growth in the biotechnology sector. The research methods we developed could also be applied to deliver other types of therapeutic cells.
Moving forward requires addressing several practical needs. Manufacturing the hydrogel at clinical scale needs further development, and regulators will want to see longer safety studies before approving human trials. We also need to test whether the platform works with other immune cells beyond NK cells. Getting this technology to patients will require substantial funding for clinical trials and regulatory work. Partnerships with pharmaceutical companies could provide both financial resources and expertise in navigating complex approval processes. We'll also need to build relationships with cancer specialists who would eventually use this treatment and ensure our patents protect the technology in major markets worldwide.
The project met all its goals and produced a working cell delivery system. We showed that NK cells stay alive for over five days in the hydrogel and remain effective against cancer cells after release. Animal studies confirmed the treatment is safe and works better than traditional injection methods. A biotech company wants to license our patent, and we're preparing to publish our findings. The technology is ready to move from laboratory research toward eventual clinical testing and patient treatment.
The commercial prospects look promising. A biotech company has already expressed interest in licensing the technology, and we've filed patent protection. This creates opportunities for job creation and economic growth in the biotechnology sector. The research methods we developed could also be applied to deliver other types of therapeutic cells.
Moving forward requires addressing several practical needs. Manufacturing the hydrogel at clinical scale needs further development, and regulators will want to see longer safety studies before approving human trials. We also need to test whether the platform works with other immune cells beyond NK cells. Getting this technology to patients will require substantial funding for clinical trials and regulatory work. Partnerships with pharmaceutical companies could provide both financial resources and expertise in navigating complex approval processes. We'll also need to build relationships with cancer specialists who would eventually use this treatment and ensure our patents protect the technology in major markets worldwide.
The project met all its goals and produced a working cell delivery system. We showed that NK cells stay alive for over five days in the hydrogel and remain effective against cancer cells after release. Animal studies confirmed the treatment is safe and works better than traditional injection methods. A biotech company wants to license our patent, and we're preparing to publish our findings. The technology is ready to move from laboratory research toward eventual clinical testing and patient treatment.