Periodic Reporting for period 1 - STI-001 (Turn Cancer Immunotherapy Effective in Most Patients)
Période du rapport: 2019-12-01 au 2020-05-31
Stimunity is a spin-off of the French foundation for cancer research, Institute Curie, exploiting a cutting-edge new cancer immunotherapy. The company was created in 2016 by Dr Nicolas Manel (scientific leader) and Sylvain Carlioz (business leader), based on more than 10-years of EU-sponsored research on the innate immune system and several scientific publications including two breakthrough papers published in Science.
In cancer, recent new immunotherapies based on use of immune checkpoint inhibitors have resulted in breakthrough respond on advanced cancer disease (Nobel Prize in 2018). Nevertheless, there are still >50% of patients that do not respond to these therapies, leaving about 5 million patients worldwide without any other therapeutic option.
Stimunity develops a new paradigm to cure patients with advanced or metastatic cancers that could not benefit from the existing immunotherapies. Stimunity’s STI-001 is the first new biological drug based on a safe Virus-Like Particles which activates the immune system against tumour cells through the innate immunity and the STING (Stimulator of Interferon Genes) pathway. This approach has the potential to reactivate immune defence against tumour cells in non-responding patients.
The present proposal’s goal is to confirm:
(i) the technical feasibility of STI-001 manufacturing
(ii) its preclinical package attractiveness, through a patent freedom to operate, a regulatory analysis, and a market study.
In cancer, recent new immunotherapies based on use of immune checkpoint inhibitors have resulted in breakthrough respond on advanced cancer disease (Nobel Prize in 2018). Nevertheless, there are still >50% of patients that do not respond to these therapies, leaving about 5 million patients worldwide without any other therapeutic option.
Stimunity develops a new paradigm to cure patients with advanced or metastatic cancers that could not benefit from the existing immunotherapies. Stimunity’s STI-001 is the first new biological drug based on a safe Virus-Like Particles which activates the immune system against tumour cells through the innate immunity and the STING (Stimulator of Interferon Genes) pathway. This approach has the potential to reactivate immune defence against tumour cells in non-responding patients.
The present proposal’s goal is to confirm:
(i) the technical feasibility of STI-001 manufacturing
(ii) its preclinical package attractiveness, through a patent freedom to operate, a regulatory analysis, and a market study.
Overall, the H2020 SME phase 1 project is a success leading to major GO decision to move forward the business:
#1. We have identified a process that is fully GMP compatible to produce STI-001 with acceptable yield. This work secure the transfer-ability of the project to the industrial scale level. This will allow us to re-insure investors to the potential of the project at the industrial scale level. STI-001 also demonstrates that it has the potential to be systemically administrated which is a key unique feature compared to the competition and, overall with its unique mechanism of action and the way it induces a potent synergy with immune checkpoint inhibitors, this demonstrates the medical potential of STI-001. This leads to a patent application that is ongoing.
#2. The Freedom-to-operate analysis is positive and the regulatory analysis did not identified any bottleneck to human translation. This clearly confirm that there is no major barrier from translation to preclinical to clinical studies.
#3. Market analysis concludes of a clear market opportunity on the STING therapeutic target with a product that can be administrated systemically which is the unique case of STI-001 and confirm the business potential of the project.
#1. We have identified a process that is fully GMP compatible to produce STI-001 with acceptable yield. This work secure the transfer-ability of the project to the industrial scale level. This will allow us to re-insure investors to the potential of the project at the industrial scale level. STI-001 also demonstrates that it has the potential to be systemically administrated which is a key unique feature compared to the competition and, overall with its unique mechanism of action and the way it induces a potent synergy with immune checkpoint inhibitors, this demonstrates the medical potential of STI-001. This leads to a patent application that is ongoing.
#2. The Freedom-to-operate analysis is positive and the regulatory analysis did not identified any bottleneck to human translation. This clearly confirm that there is no major barrier from translation to preclinical to clinical studies.
#3. Market analysis concludes of a clear market opportunity on the STING therapeutic target with a product that can be administrated systemically which is the unique case of STI-001 and confirm the business potential of the project.
On the manufacturing, the project leads to a scalable and industrial level process that is fully compatible to GMP standard which a step ahead the start of the art regarding Virus-Like Particles production. This will reinforce the manufacturing expertise and secrets within Stimunity's team. We believe that keeping it secret will have more impact on our business and building up Stimunity whereas filling a patent application and disclosing our process. We also demonstrate that STI-001 is working systemically which was unexpected and ahead the state of the art for STING agonists as all active STING products were intra-tumorally administrated. This gives us a strong differentiation standpoint and is currently being protection with a patent application. FTO and market analysis is reinforcing our attractiveness for investors. Overall, this work will help us to prepare our next round of financing for 30 million € in 2021 and scale Stimunity to a major STING biotech in Europe.