Periodic Reporting for period 1 - READY (Getting ready to treat human patients with nanobody-targeted photodynamic therapy)
Berichtszeitraum: 2020-01-01 bis 2022-04-30
The fundamental objective of this ERC Proof of Concept project was to ascertain the technical and commercial viability of our recently developed therapy, i.e. nanobody-targeted photodynamic therapy (PDT) for head and neck cancer. Nanobody-photosensitizer conjugates exhibit improved tumor distribution and faster clearance, allowing more rapid activation through light application. This therapy is consequently associated with reduced side effects, and improved cancer destruction, compared to conventional PDT or antibody-targeted PDT. Within this project, we aimed to:
1. Humanize the lead nanobody, validate the results, and explore the GMP production:
Several candidates were produced and tested for their binding properties and efficacy when conjugated to the photosensitizer, compared to the wild type lead nanobody. From a set of 18 candidates, the 2 final candidates will be subjected to final in vitro studies and the selected humanized version will be tested in vivo for efficacy in nanobody targeted PDT, compared to the wild type.
2. Perform an IP landscape analysis and establish freedom-to-operate (FTO):
Photoimmunotherapy (antibody-targeted PDT) is a very competitive intellectual property space. Antibodies and fragments thereof appeared to be of significant importance for targeting photosensitizers. IRDye700DX (the PS used in nanobody targeted PDT) often seemed to be the photosensitizers of choice. Of those working in the photoimmunotherapy space, one company appears to dominate the landscape.
Concerning freedom to operate, a number of patents were identified that could potentially block positions in the US or in Europe.
3. Execute an extensive market, competitor, and stakeholder analysis:
Further development of the nanobody-photosensitizer technology holds potential for patentability, in which case there is a moderate sustainable market potential. To commercialize the nanobody-PS and capture the value, IP protection is required. Nanobody-targeted PDT offers a unique value proposition compared to photodynamic therapies currently on the market. There is a large potential addressable market. There is a moderate threat of new entrants and/or substitutes.
4. Develop a detailed business plan to guide commercialisation of nanobody-targeted PDT:
Nanobody-targeted PDT is currently not patented. The IP report concludes the freedom to operate is questionable, but there could be opportunities which will be considered by the PI of the project.
1. Humanize the lead nanobody, validate the results, and explore the GMP production:
Several candidates were produced and tested for their binding properties and efficacy when conjugated to the photosensitizer, compared to the wild type lead nanobody. From a set of 18 candidates, the 2 final candidates will be subjected to final in vitro studies and the selected humanized version will be tested in vivo for efficacy in nanobody targeted PDT, compared to the wild type.
2. Perform an IP landscape analysis and establish freedom-to-operate (FTO):
Photoimmunotherapy (antibody-targeted PDT) is a very competitive intellectual property space. Antibodies and fragments thereof appeared to be of significant importance for targeting photosensitizers. IRDye700DX (the PS used in nanobody targeted PDT) often seemed to be the photosensitizers of choice. Of those working in the photoimmunotherapy space, one company appears to dominate the landscape.
Concerning freedom to operate, a number of patents were identified that could potentially block positions in the US or in Europe.
3. Execute an extensive market, competitor, and stakeholder analysis:
Further development of the nanobody-photosensitizer technology holds potential for patentability, in which case there is a moderate sustainable market potential. To commercialize the nanobody-PS and capture the value, IP protection is required. Nanobody-targeted PDT offers a unique value proposition compared to photodynamic therapies currently on the market. There is a large potential addressable market. There is a moderate threat of new entrants and/or substitutes.
4. Develop a detailed business plan to guide commercialisation of nanobody-targeted PDT:
Nanobody-targeted PDT is currently not patented. The IP report concludes the freedom to operate is questionable, but there could be opportunities which will be considered by the PI of the project.