Periodic Reporting for period 1 - FRAME (FRAME - tumor genome-based personalized anti-cancer vaccines off-the-shelf)
Okres sprawozdawczy: 2019-08-01 do 2020-01-31
Frame Therapeutics (formally registered as Frame Pharmaceuticals B.V.) is a Dutch start-up company with the ambition to disrupt cancer immunotherapy based on its proprietary frame vaccine technology. Frame Therapeutics has developed a ground breaking strategy to detect frame neoantigen targets in tumors and use these targets for the design of highly effective frame vaccines. The product pipeline of Frame Therapeutics consists of both off-the-shelf vaccines that are cost-efficient and readily available to subgroups of cancer patients, as well as personalized vaccines that are tailor-made and are expected to trigger the strongest immune response.
The most advanced product concerns a personalized frame vaccine that can be applied to a large array of cancer types, but will be first clinically tested in patients with advanced stage lung cancer. The current treatment regimen for patients with metastatic lung cancers concerns a combination of chemotherapy and checkpoint immunotherapy. Only a small proportion of patients responds well to such treatment stressing the need for improved therapy. By carefully selecting strongly immunogenic frames in cancer genome sequencing data of lung cancer patients, we will generate effective vaccines that trigger a more specific immune response against the cancer. The clinical benefit of such strategy is enormous and the same vaccination procedure can be extended towards many other cancer types.
The main objectives of this feasibility study were to perform strategic planning of the (pre-) clinical development path, (ii) identify critical regulatory hurdles towards clinical application and registration, (iii) understand the patent landscape and determine the freedom to operate, (iv) perform a competitor analysis and define business models for future growth.
The most advanced product concerns a personalized frame vaccine that can be applied to a large array of cancer types, but will be first clinically tested in patients with advanced stage lung cancer. The current treatment regimen for patients with metastatic lung cancers concerns a combination of chemotherapy and checkpoint immunotherapy. Only a small proportion of patients responds well to such treatment stressing the need for improved therapy. By carefully selecting strongly immunogenic frames in cancer genome sequencing data of lung cancer patients, we will generate effective vaccines that trigger a more specific immune response against the cancer. The clinical benefit of such strategy is enormous and the same vaccination procedure can be extended towards many other cancer types.
The main objectives of this feasibility study were to perform strategic planning of the (pre-) clinical development path, (ii) identify critical regulatory hurdles towards clinical application and registration, (iii) understand the patent landscape and determine the freedom to operate, (iv) perform a competitor analysis and define business models for future growth.
A thorough pre-clinical and clinical development plan has been devised, based on numerous discussions with key opinion leaders in the field of genomics, clinical oncology, cancer immunotherapy and pre-clinical testing. A series of pre-clinical and early clinical experiments have been performed and proof-of-concept was obtained for use of frames as cancer vaccines. In addition, the path towards a first-in-human clinical study has been outlined and first contacts with vaccine manufacturers have been established, including strategic collaborations with companies developing specific vaccine delivery platforms.
The patent landscape in the field of neoantigen-based cancer vaccination has been thoroughly studied by our team of patent lawyers. In addition, the strengths of the patent portfolio of Frame Therapeutics has been assessed in the light of the existing patent landscape. Based on this analysis we have specified a path forward, where Frame Therapeutics owns the territory and has freedom to operate for full commercial exploitation of frame vaccines.
A thorough analysis of business models has been performed, in light of the competitor landscape and product focuses and trial designs of companies acting in the same field. On the technical side, Frame Therapeutics has a unique focus on frame neoantigens as targets for their vaccines. In addition, technological choices with regard to neoantigen discovery and prioritization as well as methods for vaccine delivery are being made which further discern Frame Therapeutics from other companies that develop therapeutic cancer vaccines.
In conclusion, the overall strategy of Frame Therapeutics for the development and commercialization of their frame vaccines seems very feasible. In the short term, Frame Therapeutics will finalize their pre-clinical development and initiate a first clinical trial in lung cancer. Clinical data are expected within two years of time. By strategic collaboration with partner companies and universities, Frame Therapeutics is expected to contribute major advances to the field of cancer immunotherapy with their proprietary frame vaccine technologies.
The patent landscape in the field of neoantigen-based cancer vaccination has been thoroughly studied by our team of patent lawyers. In addition, the strengths of the patent portfolio of Frame Therapeutics has been assessed in the light of the existing patent landscape. Based on this analysis we have specified a path forward, where Frame Therapeutics owns the territory and has freedom to operate for full commercial exploitation of frame vaccines.
A thorough analysis of business models has been performed, in light of the competitor landscape and product focuses and trial designs of companies acting in the same field. On the technical side, Frame Therapeutics has a unique focus on frame neoantigens as targets for their vaccines. In addition, technological choices with regard to neoantigen discovery and prioritization as well as methods for vaccine delivery are being made which further discern Frame Therapeutics from other companies that develop therapeutic cancer vaccines.
In conclusion, the overall strategy of Frame Therapeutics for the development and commercialization of their frame vaccines seems very feasible. In the short term, Frame Therapeutics will finalize their pre-clinical development and initiate a first clinical trial in lung cancer. Clinical data are expected within two years of time. By strategic collaboration with partner companies and universities, Frame Therapeutics is expected to contribute major advances to the field of cancer immunotherapy with their proprietary frame vaccine technologies.
Metastatic lung cancer is a devastating disease with a poor response rate to existing therapies. By developing a unique vaccination strategy against (lung) cancer, Frame Therapeutics aims to disrupt the cancer immunotherapy landscape and generate major clinical benefit to thousands of cancer patients in the EU and worldwide.