Periodic Reporting for period 1 - uBeat (Mimic human complexity in a Beat to revolutionize the drug development)
Reporting period: 2022-06-01 to 2022-11-30
BiomimX is an R&D-performing SME specialized in the development of Beating Organ-on-Chip (OoC) platforms, a new generation of in vitro preclinical tools, built upon BiomimX proprietary cutting-edge technology, which enables to generate in vitro replica of human tissue with an unprecedented level of maturation. This technological platform allows for reliable, faster and more affordable screening of drug and medical devices.
Also thanks to the contribution of Women TechEU programme, BiomimX aims at demonstrating the unprecedented potential of its disruptive innovation in reshaping the market of drug development, by i) boosting technological aspects and ii) proving the versatility of its innovation and its capacity to adapt to a manifold of indications and market spaces. The success of BiomimX ambitious plan will be guaranteed by a solid IPR, a strong internal know- how, and already identified partnerships with EU leaders in industrialization, regulations for preclinical drug safety screening and clinical partners.
The past 60 years have seen huge advances in many of the scientific, technological and managerial factors that should tend to raise the efficiency of commercial drug research and development (R&D). Yet the number of new drugs approved per billion US dollars spent on R&D has halved roughly every 9 years since 1950, falling around 80-fold in inflation-adjusted terms. The cost to develop a new single drug is today estimated around 2.8B$ and the average time to market is 12.5 years, with both trends continuously growing1. Less than 1/10’000 of the initially investigated candidate drugs reach the market, while the others fail along the way2. The further in the drug discovery pipeline (DDP) the failure occurs, the higher is the waste of investment, in terms of money, time and human safety. Notably, only less than 12% of new candidate drugs make the transition from pre-clinical to clinical development1. Nonetheless, despite this great waste, the risk to introduce in clinical trial ineffective or even toxic molecules is still high, due to the poor predictability of the currently exploited preclinical test models. Such negative trends are mostly related to the accepted reality that current preclinical tests are only an imperfect representation of the human system, thus providing unreliable data often insufficient to guide preclinical-to-clinical transition, where solid and clinically relevant outcomes would instead facilitate safer and more reliable go/not-go decisions. Currently available preclinical tools for testing drug safety/benefit indeed rely either on i) bi-dimensional (2D) cell culture methods poorly resembling native tissues complexity and thus failing in capturing human responses, or ii) animal models, that often lack in predicting human responses due to inter-species differences. Moreover, 3R principles are forcing Pharma to reduce the use of animals (Directive 2010/63/EU): EU Parliament (EP) recently voted yes to a to a future without animal experiments and “It is now in the hands of the European Commission to establish this EU- wide Action Plan, and we expect the EC will make this a high-level”, said Jytte Guteland (EP member) 3.
BiomimX is at the frontline to speed up this resolution, contributing to a key EU priority, by offering its in vitro human advanced models as visionary tools for reducing (and eventually replacing) animal testing in preclinical DDP.
Also thanks to the contribution of Women TechEU programme, BiomimX aims at demonstrating the unprecedented potential of its disruptive innovation in reshaping the market of drug development, by i) boosting technological aspects and ii) proving the versatility of its innovation and its capacity to adapt to a manifold of indications and market spaces. The success of BiomimX ambitious plan will be guaranteed by a solid IPR, a strong internal know- how, and already identified partnerships with EU leaders in industrialization, regulations for preclinical drug safety screening and clinical partners.
The past 60 years have seen huge advances in many of the scientific, technological and managerial factors that should tend to raise the efficiency of commercial drug research and development (R&D). Yet the number of new drugs approved per billion US dollars spent on R&D has halved roughly every 9 years since 1950, falling around 80-fold in inflation-adjusted terms. The cost to develop a new single drug is today estimated around 2.8B$ and the average time to market is 12.5 years, with both trends continuously growing1. Less than 1/10’000 of the initially investigated candidate drugs reach the market, while the others fail along the way2. The further in the drug discovery pipeline (DDP) the failure occurs, the higher is the waste of investment, in terms of money, time and human safety. Notably, only less than 12% of new candidate drugs make the transition from pre-clinical to clinical development1. Nonetheless, despite this great waste, the risk to introduce in clinical trial ineffective or even toxic molecules is still high, due to the poor predictability of the currently exploited preclinical test models. Such negative trends are mostly related to the accepted reality that current preclinical tests are only an imperfect representation of the human system, thus providing unreliable data often insufficient to guide preclinical-to-clinical transition, where solid and clinically relevant outcomes would instead facilitate safer and more reliable go/not-go decisions. Currently available preclinical tools for testing drug safety/benefit indeed rely either on i) bi-dimensional (2D) cell culture methods poorly resembling native tissues complexity and thus failing in capturing human responses, or ii) animal models, that often lack in predicting human responses due to inter-species differences. Moreover, 3R principles are forcing Pharma to reduce the use of animals (Directive 2010/63/EU): EU Parliament (EP) recently voted yes to a to a future without animal experiments and “It is now in the hands of the European Commission to establish this EU- wide Action Plan, and we expect the EC will make this a high-level”, said Jytte Guteland (EP member) 3.
BiomimX is at the frontline to speed up this resolution, contributing to a key EU priority, by offering its in vitro human advanced models as visionary tools for reducing (and eventually replacing) animal testing in preclinical DDP.
The uBeat project lasted six months and was focused on two main activities i) definition and implementation of a fundraising strategy (T1) and ii) engagement of key stakeholders among Pharma companies (T2).
The two main milestones related to the two objectives of the proposal were matched as described above:
1. Establish high-level commercial relationship with Pharma players, to validate the impact of BiomimX’s solution in the drug developmental pipeline. Regarding this milestone, three contracts were successfully signed.
2. Closure of a seed round dedicated to market deployment of BiomimX’s first product (uBeat setups, together with the case studies) and to the scale up of the business towards the R&D development of new uBeat-based biological models and new integrated technologies.
The two main milestones related to the two objectives of the proposal were matched as described above:
1. Establish high-level commercial relationship with Pharma players, to validate the impact of BiomimX’s solution in the drug developmental pipeline. Regarding this milestone, three contracts were successfully signed.
2. Closure of a seed round dedicated to market deployment of BiomimX’s first product (uBeat setups, together with the case studies) and to the scale up of the business towards the R&D development of new uBeat-based biological models and new integrated technologies.
In five years, BiomimX aims at becoming market leader in the OoC scenario: OoC market is rather new, but its impact in the DDP is already clear to the main stakeholders. The drug discovery segment of the OoC market is indeed expected to hold the largest market share and is projected to witness a CAGR of 34.72% during the forecast period. Toxicology research segment by application will gain $22.3M biopharmaceutical companies’ segment by end-users will gain $41.7M of global annual sales by 2023. In this scenario, there is a high expectation on the potentiality of OoC in addressing the needs of pharmaceutical industries. Both public and private sources have substantially funded OoC start-ups and research groups during the last few years, mainly in USA (Emulate Inc.). These geographical areas thus boast a competitive advantage compared to Europe in this fast-growing market. However, only few players are currently in the production and commercialization phase; and while pharmaceutical and cosmetics companies are engaged in an iterative process to test different OoC solutions, they are conservative and might need time to adopt the technology widely. Indeed, before the expected OoC impact could be achieved, innovative solutions are however required to ensure a sufficient maturation of cellular models. BiomimX aims at filling this gap and taking a consistent segment of the OoC market in Europe in the next 5 years, thanks to its “first mover advantage” represented by uBeat® technology, a brand-new technological solution enabling through mechanical and electrical stimulation to generate 3D mature preclinical models offering high predictivity (e.g. 95% for detection of cardiotoxicity) and unprecedented clinical translational value (e.g. ability to reproduce in vitro human models of pathologies for the first time, like osteoarthritis). While the potential of Beating OoC has already been demonstrated in our validated case studies, the versatility of uBeat® technology (and of future complementary technologies already in R&D) allows to rapidly extend BiomimX’s solutions to different Context of Use, thus exponentially increasing market opportunities. Notably, the release of the first industrialized uBeat® Platforms will drastically speed-up the validations of new models, boosting their TRL and speeding-up their adoption by end-users. Indeed, once a new variant of uBeat® Platform will be industrialized, the time to implement additional plugin models is anticipated to be a straightforward process.
Participation to the Women TechEU programme would boost the visibility of BiomimX’s solution among stakeholders and facilitate high-level partnership with key player in the field to speed up OoC adoption by Pharma companies. This is the right moment to demonstrate Beating OoC are the solution for the future of drug development, and BiomimX is ready to take this occasion and demonstrate the disruptive value of its innovation.
Participation to the Women TechEU programme would boost the visibility of BiomimX’s solution among stakeholders and facilitate high-level partnership with key player in the field to speed up OoC adoption by Pharma companies. This is the right moment to demonstrate Beating OoC are the solution for the future of drug development, and BiomimX is ready to take this occasion and demonstrate the disruptive value of its innovation.