Periodic Reporting for period 1 - MOOD (Feasibility Study for the introduction into pre-clinical study domain of the first-of-a-kind Multi Organ On Device (MOOD) technology)
Reporting period: 2018-08-01 to 2019-01-31
The Multi In Vitro Organ (MIVO) device is a disposable fluid-dynamic, multi-chamber culture system developed by React4Life, able to emulate portions of the human body. It is coupled with a high-engineered 3D cell laden hydrogel tumor model, with the aim to validate anticancer therapies improving the effectiveness of pharmaceutical tests and reducing animal testing. By recreating cell migration phenomena, MIVO allows the study of cancer metastasis onset and offers a new instrument for anticancer therapies validation. This allows changing the way pre-clinical research is carried out, by offering researchers an all-in-one solution to replace in vitro tests and animal tests for validating the best drug candidates for the clinical phase on humans.
MIVO represents a step-forward with respect to the animal model in terms of capacity to model in a more standard and reproducible way the dynamic behaviour of the human organism, thus allowing to use mice or other rodents only to validate the results of in vitro tests, as requested by the regulation in force. Considering the huge economic value of a single cycle of medical research, minimise the number of mice used during trials could represent significant savings for researchers. These achievements make our 3D tumour model and the bioreactor-based intravasation set-up superior to all available models and migration assays, because the latter do not allow to culture cells in a 3D dynamic environment of clinically relevant size and, at the same time, biologically active. This is poised to introduce a disruptive change in the global in vitro cell research, and considering the societal relevance of metastasis and the poor scientific knowledge about the metastatic onset, MIVO responds to a strong need on novel approaches to cancer treatment.
The Phase 1 Project objectives are:
Goal 1: Streamline the product development through iterative and comparative trials, where the MIVO KPIs will be compared with the animal models.
Goal 2: Define an Operational Plan, which will lead to the definition of the project work plan for the Clinical Validation as RuO.
Goal 3: Perform a risk assessment
Goal 4: Explore the Business Feasibility in order to ensure that the business opportunity behind the MIVO technology exists, and is sustainable for R4L
MIVO represents a step-forward with respect to the animal model in terms of capacity to model in a more standard and reproducible way the dynamic behaviour of the human organism, thus allowing to use mice or other rodents only to validate the results of in vitro tests, as requested by the regulation in force. Considering the huge economic value of a single cycle of medical research, minimise the number of mice used during trials could represent significant savings for researchers. These achievements make our 3D tumour model and the bioreactor-based intravasation set-up superior to all available models and migration assays, because the latter do not allow to culture cells in a 3D dynamic environment of clinically relevant size and, at the same time, biologically active. This is poised to introduce a disruptive change in the global in vitro cell research, and considering the societal relevance of metastasis and the poor scientific knowledge about the metastatic onset, MIVO responds to a strong need on novel approaches to cancer treatment.
The Phase 1 Project objectives are:
Goal 1: Streamline the product development through iterative and comparative trials, where the MIVO KPIs will be compared with the animal models.
Goal 2: Define an Operational Plan, which will lead to the definition of the project work plan for the Clinical Validation as RuO.
Goal 3: Perform a risk assessment
Goal 4: Explore the Business Feasibility in order to ensure that the business opportunity behind the MIVO technology exists, and is sustainable for R4L
Goal 1: Streamline the product development through iterative and comparative trials, where the MIVO KPIs will be compared with the animal models.
We have consolidated the scientific validation of our biology-based technology by providing three different experimental outcomes:
• Breast cancer tissue growth and tumour cells intravasation under fluid-dynamic conditions
• Neuroblastoma tumour model for testing immunotherapies
• Efficacy tests of drugs against ovarian tumour model, by using MIVO in comparison with the animal model
Goal 2: Define an Operational Plan, which will lead to the definition of the project work plan for the Clinical Validation as RuO.
KOLs, such as CROs and interested R&D centers working in oncology and immunotherapies have been identified and approached, so to make aware the widest community about the opportunity to replace, reduce and refine the animal studies with the MOOD device. Comparative drug efficacy tests have been defined and conducted both in vivo and in vitro within MIVO platform to provide a scientific comparative outcome.
Goal 3: Perform a risk assessment.
The main technologic and business risks and barriers have been identified, detecting the related mitigating actions.
Goal 4: Explore the Business Feasibility.
We consolidated the MIVO’s value proposition by means of interactions with several stakeholders. A cost benefit analysis has been performed, showing that the MIVO solution allow significant savings to researchers. We consolidated the MIVO’s value chain and defined the commercialization strategy to enter the market, including the economic and financial projections for the 2019-2023 period. We also defined the IPR strategy.
We have consolidated the scientific validation of our biology-based technology by providing three different experimental outcomes:
• Breast cancer tissue growth and tumour cells intravasation under fluid-dynamic conditions
• Neuroblastoma tumour model for testing immunotherapies
• Efficacy tests of drugs against ovarian tumour model, by using MIVO in comparison with the animal model
Goal 2: Define an Operational Plan, which will lead to the definition of the project work plan for the Clinical Validation as RuO.
KOLs, such as CROs and interested R&D centers working in oncology and immunotherapies have been identified and approached, so to make aware the widest community about the opportunity to replace, reduce and refine the animal studies with the MOOD device. Comparative drug efficacy tests have been defined and conducted both in vivo and in vitro within MIVO platform to provide a scientific comparative outcome.
Goal 3: Perform a risk assessment.
The main technologic and business risks and barriers have been identified, detecting the related mitigating actions.
Goal 4: Explore the Business Feasibility.
We consolidated the MIVO’s value proposition by means of interactions with several stakeholders. A cost benefit analysis has been performed, showing that the MIVO solution allow significant savings to researchers. We consolidated the MIVO’s value chain and defined the commercialization strategy to enter the market, including the economic and financial projections for the 2019-2023 period. We also defined the IPR strategy.
By introducing the first 3D human tissue culture embedded in a living fluid-dynamic environment, MIVO gives researchers the opportunity to test drug candidates in the pre-clinical phase using a platform that replicates the dynamic behaviour of the target organ, overcoming the limits of static in vitro tests and the lack of validity and reproducibility of animal models. MIVO offers a disruptive change in the global in vitro cell research, providing scientists and researchers with the following unique benefits:
- Robust and reliable tool for realistic analysis of cellular behaviour within tumor metastatisation: MIVO combines a clinically relevant size 3D tumor model with a fluid-dynamic bioreactor offering high reliability to researchers, which is expected to decrease the failure rate during clinical trials.
- Very fast pre-screening process with dramatic time savings if compared with animal models: MIVO is a disposable ready-to-use device, which allows savings of time and money.
- Low cost platform for preclinical drug testing that allows huge savings in terms of trial execution costs.
Socio-economic impact and societal implications of the project include:
- Ethical aspects of animal research: the MIVO technology permits a significant reduction of mice used in pre-clinical tests
- Improved effectiveness of pharmaceutical tests enhancing pre-clinical trials reliability.
- Possibility to effectively test emerging anti-cancer therapies, like immunostimulant drugs, for which animal models are not usable.
- Strong reduction of drug development lifetime, cutting pre-clinical tests length.
- Robust and reliable tool for realistic analysis of cellular behaviour within tumor metastatisation: MIVO combines a clinically relevant size 3D tumor model with a fluid-dynamic bioreactor offering high reliability to researchers, which is expected to decrease the failure rate during clinical trials.
- Very fast pre-screening process with dramatic time savings if compared with animal models: MIVO is a disposable ready-to-use device, which allows savings of time and money.
- Low cost platform for preclinical drug testing that allows huge savings in terms of trial execution costs.
Socio-economic impact and societal implications of the project include:
- Ethical aspects of animal research: the MIVO technology permits a significant reduction of mice used in pre-clinical tests
- Improved effectiveness of pharmaceutical tests enhancing pre-clinical trials reliability.
- Possibility to effectively test emerging anti-cancer therapies, like immunostimulant drugs, for which animal models are not usable.
- Strong reduction of drug development lifetime, cutting pre-clinical tests length.