Periodic Reporting for period 1 - STI-001 (Turn Cancer Immunotherapy Effective in Most Patients)
Reporting period: 2019-12-01 to 2020-05-31
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.
#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."