The Zebrafish Lab (
http://thezebrafishlab.com/(öffnet in neuem Fenster)) a biotechnological company leader in the development and commercialization of novel, tailor-made solutions based on in vivo zebrafish assays. Our mission is to offer our innovative solutions to a wide range of industry sectors, with a major focus on the healthcare and pharmaceutical industries. Thanks to the extensive knowledge acquired by the R&D projects performed in the field by our team for many years and a close collaboration with Hospitals and Cancer Research Institutions, we have identified a substantial clinical and commercial opportunity in bringing to the healthcare market a novel real time in vivo platform for personalized cancer treatment. This business opportunity is the one presented as MY FISH CURE project and it is based on the use of zebrafish “avatars” as personalized-living test tubes. The explanation of MY FISH CURE project concept it is summarized herein.
MY FISH CURE PROJECT CONCEPT:
The main objective of MY FISH CURE project is to bring to the healthcare market a simple, cost-effective, and faithful in vivo model based on the use of zebrafish “avatars” to guide therapeutic decisions in actionable cancer patient-directed interventions (personalized medicine).
Nowadays and specially when referring to cancer treatment, doctors and drug developers are increasingly focused on treatments based on a personalized medicine approach. This approach is fundamentally based on studying the genetic profile of each patient, understanding their genetic makeup and how the tumor develops and grows. This innovative approach enables them to customize treatment to each patient’s needs for an increased efficiency and with fewer side and toxic effects.
Before the appearance of Personalized Medicine, most patients with a specific type and stage of cancer received the same treatment and the results show that some treatments worked better for some patients than for others, being in fact some patients who do not even respond to the prescribed treatments whatsoever.
This can be explained due to different challenges associated to cancer therapies: a) one of them is to the difficulty in identifying group of patients with the same diagnosis so to correctly stratifying them according to the toxicity responses and benefits associated to the drug administration (See figure 1), b) another important challenge is to define the best drug combinations to eradicate and combat carcinogenic cells after diagnosis and in case of cancer recurrence.
How to combat cancer using personalized medicine?
The idea is to analyze individually the patient tumor to determine what combination of drugs will work best.
Many different approaches have been developed so far and currently the most extended approach is the use of molecular profiling of biopsied tissue using in vitro cell culture assays. This approach is founded upon the idea that tumor biomarkers are associated with patient prognosis and tumor cells response to therapy. Although this approach has demonstrated effectiveness in certain cases, it founds limitations when it comes to predict how cancer will actually progress in a living organism.
The in vitro characterization is only made after the tumor is biopsied, so it only provides information of the tumor at a certain point in time, limiting the prediction of cancer proliferation, migration, metastasis, recurrence, and resistance to treatment. The major challenge in prediction of cancer progress in a living organism is that the study of the tumor by itself, do not seem an effective approach without knowing more about the interactions that take place between tumor and normal cell populations. These interactions are indispensable to understand cancer progression. Therefore, despite all the promises of molecular profiling for cancer treatment personalization, the in vitro models will hardly provide an effective solution, because it is extremely difficult to simulate the tumor microenvironment of a living organism in an in vitro cell culture assay .
Conversely, in vivo models (also known as “Avatars”), allow studying cancer progression with different treatments in a living environment, so they open the door to a more effective personalized approach. However, although in vivo models have been widely used un pre-clinical drug development and, to a less extent, as tools for personalized anticancer therapy, their widespread use in clinic is currently prevented mostly because of the completely unfordable cost (for example mouse avatars are being offered to patients at about 12.000€).
The solution proposed in MY FISH CURE project is to use zebrafish avatars as a cost effective (costs lower than 500€/patient) in vivo platform to guide oncologist finding the best therapeutic option for each patient. These zebrafish avatars will be generated by xenotransplantation of human cancer cell lines and primary tumor samples in zebrafish and these avatars will serve as living test tubes to evaluate the efficiency and toxicity of different drug combinations, so to find the best treatment for each patient: the best survival rates and the lowest toxicity (side effects) results founded in ZB avatars will serve to identify the best drug combination for each patient.
MY FISH CURE: Objectives of the action
The ultimate objective we sought for MY FISH CURE project during Phase 1 was to anticipate the possible potential risk that could appear during the project development to ensure that our business innovation project will be efficient and productive. Having this objective in mind, the Phase 1 was developed as a feasibility study with the ultimate objective of determining the key aspects for the prosperous implementation of our ZB in vivo platform as a companion diagnostic test, useful for oncologists to determine which drug combination will be the best option for each patient. The specifics objectives for the action were as follows:
To target Key Opinion Leaders within the Oncology, Pharmaceutical and Cancer Research Communities, to validate the potential of the proposed solution in the market.
To enlarge our network of collaborators by putting in place new collaboration agreements with the Research Institutions and Biobanks that are needed to complete the R&D activities essential to bring MY FISH CURE to the market.
To define the regulatory pathway for us to follow in order to achieve the clinical trial approval by the pertinent ethic committees for clinical experimentation with human samples and by the regulatory bodies (EMA/FDA) to commercialize our solution as a clinical tool for cancer patients’ management.
To perform an in-depth market analysis, that includes the analysis of main market features, drivers and barriers, geographic markets of major interest and the requirements to access them.
To carry out a comprehensive financial analysis (5 years business plan): investment needs, financial projections (P&L, cash flow projections) and sensitive analysis.
To perform an in-depth risk analysis and define a contingency plan.
