Periodic Reporting for period 1 - TrojanDC (TrojanDC)
Reporting period: 2019-12-01 to 2020-05-31
Asgard Therapeutics AB is a Swedish start-up company that was founded in 2018 as a spin-off from Lund University. Asgard Therapeutics aims to advance cancer immunotherapies by developing a paradigm-shifting gene therapy consisting of reprograming tumor cells into immune cells that trigger a massive antitumor immune response. The current treatment regimen for patients with solid cancers concerns a combination of surgery, radiotherapy, chemotherapy and immunocheckpoint inhibitors (ICI). Unfortunatly only a small proportion of patients responds well to such treatment stressing the need for improved therapy.
Asgard’s novel approach named TrojanDC is a high-potential innovation that directly reprograms cancer cells into functional antigen-presenting dendritic cells cells. TrojanDC is a proprietary gene-therapy, a viral vector that is directly injected into solid tumors and delivers reprogramming factors. Upon expression of these transcription factors, transduced tumor cells gain functional features of naturally occurring dendritic cells, immune cells that excel on antigen presentation. These tumor-derived dendritic cells will still have cancer-specific antigens, which they now present on their cell-surface to elicit an effective and robust anti-cancer immune response.
Because tumor-specificity is generated within the tumor, TrojanDC is an off-the-shelf – yet tumor-specific – therapy that does not require complex procedures such as autologous cell manipulation. It therefore has similar or reduced production costs when compared to typical vaccine manufacturing. Moreover, synergistic effects between TrojanDC and ICIs are likely as ICIs are most effective in an active immune environment.
Asgard's envisioned that the development of its TrojanDC therapy will contribute towards an improved and more sustainable treatment for various types of solid cancers. Not only will this positively impact the lives of many patients suffering from cancer, but also their close relatives and healthcare systems that currently have large expenditures on expensive cancer therapeutics with questionable effectivity.
The main objectives of this feasibility study were to define product features essential for market feasibility, develop a intellectual property strategy, including FTO Assessment, development of a regulatory strategy with the EMEA/FDA, analysis of all preclinical activities, including financial requirements up to clinical phase 2 and as a final deliverable develop a business plan.
Asgard’s novel approach named TrojanDC is a high-potential innovation that directly reprograms cancer cells into functional antigen-presenting dendritic cells cells. TrojanDC is a proprietary gene-therapy, a viral vector that is directly injected into solid tumors and delivers reprogramming factors. Upon expression of these transcription factors, transduced tumor cells gain functional features of naturally occurring dendritic cells, immune cells that excel on antigen presentation. These tumor-derived dendritic cells will still have cancer-specific antigens, which they now present on their cell-surface to elicit an effective and robust anti-cancer immune response.
Because tumor-specificity is generated within the tumor, TrojanDC is an off-the-shelf – yet tumor-specific – therapy that does not require complex procedures such as autologous cell manipulation. It therefore has similar or reduced production costs when compared to typical vaccine manufacturing. Moreover, synergistic effects between TrojanDC and ICIs are likely as ICIs are most effective in an active immune environment.
Asgard's envisioned that the development of its TrojanDC therapy will contribute towards an improved and more sustainable treatment for various types of solid cancers. Not only will this positively impact the lives of many patients suffering from cancer, but also their close relatives and healthcare systems that currently have large expenditures on expensive cancer therapeutics with questionable effectivity.
The main objectives of this feasibility study were to define product features essential for market feasibility, develop a intellectual property strategy, including FTO Assessment, development of a regulatory strategy with the EMEA/FDA, analysis of all preclinical activities, including financial requirements up to clinical phase 2 and as a final deliverable develop a business plan.
The work undertaken in this feasibility study has led to significant insight into the technical and commercial feasibility of Asgards first product, which led to considerable improvement in the development path maturation of Asgards business plan.
Commercial feasibility studies that were part of this project led to a substantial update of the development plan and refinement of Asgards and clinical strategy. We have carefully analysed safety and risks indicated by the Europeaun Medicin Agency (EMA) and Food and Drugs Administration (FDA) and developed deep understanding of possible bottlnecks for the technology. As a second pillar in this study we performed a thorough Freedom To Opperate (FTO) analysis and searched for earlier, expired patents or publications, which would possibly prevent the later issuance of a valid patent to the TrojanDC product. As a third pillar of this feasibility study we identified a regulatory strategy within the EMEA/FDA regulatory framework. Finally, as a fourth pillar of this feasibility study we identified all preclinical activities required and estimated financial requirements up to clinical phase 2 studies.
As a result of this feasibility study Asgard initiated interactions to establish partnerships with CMOs/CROs, started ongoing dialogues with (multinational) pharmacompanies and investors that are interested in the TrojanDC technology.
Commercial feasibility studies that were part of this project led to a substantial update of the development plan and refinement of Asgards and clinical strategy. We have carefully analysed safety and risks indicated by the Europeaun Medicin Agency (EMA) and Food and Drugs Administration (FDA) and developed deep understanding of possible bottlnecks for the technology. As a second pillar in this study we performed a thorough Freedom To Opperate (FTO) analysis and searched for earlier, expired patents or publications, which would possibly prevent the later issuance of a valid patent to the TrojanDC product. As a third pillar of this feasibility study we identified a regulatory strategy within the EMEA/FDA regulatory framework. Finally, as a fourth pillar of this feasibility study we identified all preclinical activities required and estimated financial requirements up to clinical phase 2 studies.
As a result of this feasibility study Asgard initiated interactions to establish partnerships with CMOs/CROs, started ongoing dialogues with (multinational) pharmacompanies and investors that are interested in the TrojanDC technology.
Solid tumors represent devastating forms of cancer with a poor response rate to existing therapies. By developing a unique reprograming technology, Asgard Therapeutics aims to disrupt the cancer immunotherapy landscape and generate major clinical benefit to thousands of cancer patients in the EU and worldwide.