Regenerativ medicin är ett framväxande forskningsområde som fokuserar på reparation, utbyte eller regenerering av celler, vävnader eller organ för att återställa nedsatt funktion. Området har potential att adressera en stor marknad och har en betydande inverkan på hälso- och sjukvårdsindustrin genom att minska bördan av vissa sjukdomar eller tillstånd som involverar vävnadsskador. Forsknings- och utvecklingsbolaget Fluicells målsättning är att äntra denna marknad genom att fokusera på utveckling av läkemedel för avancerad terapi (ATMP) baserat på transplanterbara mikrovävnader med bolagets ledande produkt, Biopixlar. BioStock kontaktade Fluicells vd Victoire Viannay för att får veta mer om initiativet och dess potentiella genomslagskraft.

Idag är patienter som lider av skador eller sjukdomar som involverar skadade celler eller vävnader starkt beroende av läkemedelsbehandling eller medicintekniska produkter som är inriktade på att förbättra symptomen, istället för att fullständigt återställa kroppsfunktioner genom t.ex. vävnadsreparation. Denna begränsning sätter stort tryck på sjukvårdssystemen, särskilt gällande kroniska eller progressiva sjukdomar som typ 1-diabetes, hjärtsvikt eller åldersrelaterad makuladegeneration (AMD), som alla kräver regelbunden, och i vissa fall, livslång hantering med de läkemedel som är tillgängliga idag.

Nu framstår dock regenerativ medicin som ett område med potential att rita om spelplanen för dessa sjukdomar och tillstånd. Regenerativ medicin skulle kunna återuppbygga skadade vävnader och organ från grunden genom att transplantera in ny bioteknisk vävnad till patienter. Detta involverar nästa generations FoU-teknik såsom t.ex. bioprinting, där celler och vävnader kan replikeras helt i laboratoriemiljö och sedan överföras för användning i forskning eller terapeutiska tillämpningar. 

Fluicell tar steget till regenerativ medicin

I Sverige är Fluicell ett bolag känt för sin bioprinting-kapacitet. Tack vare sin huvudprodukt Biopixlar, en 3D-encellsplattform för bioprinting, har Fluicell både vetenskapligt och kommersiellt kunnande att bli en viktig aktör inom regenerativ medicin. Läs mer om Fluicells affärsidé och Biopixlar här.

Den 5 maj 2021 tillkännagav Fluicell sina planer på att äntra marknaden för regenerativ medicin med Biopixlars högupplösta biotrycksfunktioner. Bolaget kommer att fokusera på att utveckla läkemedel för avancerad terapi (ATMP) baserat på transplanterbara mikrovävnader. Målet med det nya initiativet är att utveckla terapeutiska produkter inriktade på viktiga sjukdomsområden, såsom de ovannämnda, som idag saknar adekvata behandlingsalternativ och där Biopixlars bioprintningskapacitet skulle kunna tillföra stort värde.

Fluicells nya tjänster

Fluicell kommer nu att fortsätta utvecklingen av bioprintade vävnader och terapier i tre faser: utveckling av humana vävnadsmodeller in vitro 2021/2022, in vivo-testning för prekliniska studier 2022/2023 och proof-of-concept kliniska prövningar med planerad start 2026.

För detta ändamål har Fluicell presenterat ett nytt partnerskapsprogram för ATMP-forskning och utveckling: BioRej Advance. Idén bakom programmet är att producera mikrovävnader med Fluicells Biopixlar som så småningom kan transplanteras in i patientens kropp direkt på det behandlade organet. Plattformen fungerar som en teknisk ram för utveckling av avancerad terapi inom nästan alla typer av sjukdomsområden som använder någon typ av celler.

»At Fluicell, we believe that ATMPs and regenerative medicine will be an important part of the future healthcare system, and we want to take part in shaping that future. Not only is this a step for creating better human health, but it also creates an excellent opportunity to realize some of the commercial potential inherent in the Biopixlar platform. This, you could say, is the dual motivation behind the BioRej Advance program« — Victoire Viannay, vd Fluicell

Betydande marknadspotential

Potentialen inom området för regenerativ medicin är ganska betydande, då den globala marknaden för regenerativ medicinteknik förväntas nå 39 miljarder USD 2025, och enligt Fluicell förväntas framsteg inom vävnadsteknik spela en stor roll i att öka tillväxten genom att uppta ungefär 25 procent av segmentet regenerativ medicin.

Nu söker bolaget aktivt partners som tillsammans med Fluicell vill utveckla nästa generation av terapi inom regenerativ medicin för att möjliggöra nya framsteg inom sjukvården. BioStock kontaktade Fluicells vd Victoire Viannay för att få veta mer om bolagets nya initiativ och framtida planer.

Victoire Viannay, first of all, for those who are not familiar with the field, why are ATMPs such a big deal?

– Advanced therapy medicinal products (ATMPs) represent a new direction in health technology based on using modified biologically produced material, either genes, cells or tissues. The big interest in ATMPs come from the fact that it is a new product category, distinct from both pharmaceuticals and medical devices, often targeting diseases and conditions that today lack medical treatments or where existing treatments are not sufficiently effective.

– Of the different types of ATMPs, Fluicell focuses on creating tissue-engineered products, which are modified tissues that can be used for regenerative medicine purposes to repair, regenerate or replace human tissue. Here, our aim is to use Biopixlar’s high-resolution bioprinting to create tissue-based therapeutic products that takes advantage of the high level of control of the cellular microenvironment that Biopixlar offers.

Why did Fluicell decide that now was a good time to enter this market?

– We have for a long time been saying that Biopixlar is more than just a research instrument, but a fully scalable platform. Using Biopixlar’s capacity to create detailed tissues for producing new types of therapeutic application is an important part in realising some of the potential of the platform.

– There are several reasons for Fluicell to enter into therapeutic development now. One major reason is the R&D work we have been performing internally, both when it comes to bioprinting therapeutically interesting cell types, such as iPSCs (induces pluripotent stem cells), cardiac cells and more, and, perhaps more importantly, using Biopixlar to print tissues on different substrates like porous membranes that could be used to transplant bioprinted tissues into a patient. This is a very important step towards creating something that could eventually become an engineered tissue product.

– Another reason why now is the right time to enter into ATMP development has to do with market development. The ATMP market is still in a very early and exploratory phase, where many important parts, such as regulatory framework and commercial models still very much under development. While there are several ATMPs in clinical trials, mostly in the cell and gene therapy area, the number of approved treatments is still low. However, we see that many advances are being made right now, and we believe that both the market and the healthcare system will be much more prepared to handle ATMPs, and engineered tissue products specifically, when we reach the product stage, which makes initiating this program now such an ideal opportunity.

Could you tell us more about BioRej Advance and its purpose?

– At Fluicell, we believe that ATMPs and regenerative medicine will be an important part of the future healthcare system, and we want to take part in shaping that future. Not only is this a step for creating better human health, but it also creates an excellent opportunity to realize some of the commercial potential inherent in the Biopixlar platform. This, you could say, is the dual motivation behind the BioRej Advance program.

– In itself, BioRej Advance is a partnership program for ATMP development, where we offer our expertise in bioprinting and single-cell technology and where we look to partner with industrial and academic actors with the same ambition to create new treatments for high-value diseases. The program proceeds in three steps, including an initial in vitro research step followed by in vivo testing of product candidates and with clinical trials being the final step of the program. All of this is based on tissues produced using Biopixlar’s high resolution bioprinting capacity. The idea is to print tissues on transferable membranes, where the resulting construct could be grafted into a living organism to restore organ function in order to cure a disease.

– 3D bioprinting is a promising tissue engineering field that offers new opportunities to create tissues by combining cells and extracellular material layer-by-layer. However, some of the competing technologies within bioprinting have limitations such as insufficient control over individual cells during the bioprinting process, resulting in a lack of precise reconstruction of the tissue composition. With Biopixlar, we can generate complex 3D multi-cellular tissues at high-resolution and faithfully reproduce the cell microenvironment. Through the very promising proof-of-concept work we have been doing in-house and by consulting research expertise in regenerative medicine, we have identified many great opportunities for Fluicell and Biopixlar in regenerative medicine, which has been consolidating our decision to enter into this area.

 Do you have any specific areas that you want to target?

– A key part of the Biopixlar concept is high-resolution bioprinting of microtissues. This also applies to products developed through BioRej Advance. We are not looking for applications where we replace an entire organ, but to create tissues that can help to repair and restore the function of a damaged organ. Biopixlar’s microfluidic technology allows us to carefully place cells with high precision, something we believe will play an important role for the functionality of the bioprinted tissues.

– We have identified three areas of particularly high priority for therapeutic development. These are cardiac repair, type 1 diabetes and age-related macular degeneration. These are all areas with a high unmet medical need and where we see a great opportunity for Biopixlar-produced tissues to add value.

When can we expect to see the first benefits of this new service?

– For us at Fluicell, we are already seeing the first benefits from this strategic focus in terms of the advances made by our R&D team. Setting this goal has allowed our innovative research team to make great advances, both in terms of creating different tissue types and printing on different membrane materials. As for initiating partnerships, this is something that we continuously discuss with research actors across the world. We have recently initiated the work on the BIRDIE project, a research collaboration combining bioprinting and organ-on-a-chip technologies, which is giving us important experiences from managing large international research collaborations that will be important for us in establishing partnerships going forward.

– Our goal is to initiate in vivo testing of Biopixlar printed tissues in 2022/2023. This goal will be a strong driving force in our partnership efforts.

Finally, would you say that Regenerative Medicine is the future of healthcare, and do you expect Fluicell to play a big role in providing this type of medicine?

– I believe that ATMPs will have a very important role to play within healthcare in the future, specifically for targeting diseases and conditions not addressed by conventional treatments today. When you say that something is the future of healthcare, that can give the impression to the reader that this new technology will make everything that is on the market today obsolete. This is not what we are claiming, nor this is what we are trying to achieve. Instead, we want to provide more tools and increase the capabilities of healthcare professionals to help patients that today go without adequate care for conditions that cause many deaths and reduced quality of life and also lead to great societal costs.

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